Roxee Medication Guide

Tilmicosin Phosphate

Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.

Both Reference complete Livestock/food-animal use Rx required Solution Multiple FDA labelers Official label facts Owner quick guide first

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Food-animal or livestock record. This source record is for livestock or food-animal use, not a dog/cat medication profile. Food-animal rules, withdrawal intervals, and residue restrictions may apply. Do not start, stop, or change treatment without your veterinarian.

Data freshness

Reference facts

Reference refreshed

Jun 22, 2026, 10:45 a.m.

These are the reference facts Roxee uses on browse cards and quick facts.

FDA applications

FDA application data refreshed

Jun 22, 2026, 10:41 a.m.

Sponsor, product, and application records imported from Animal Drugs @ FDA.

Safety reports

No safety reports linked

No refresh timestamp yet

openFDA reaction terms and case summaries are supporting evidence, not proof of causality.

Source timing details

Reference facts: Source Roxee | Refreshed Jun 22, 2026, 10:45 AM UTC
The reference fact projection used for browse cards and quick facts.
Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:40 AM UTC
Applications/products are imported from FDA export data.
Animal Drugs @ FDA previews: Source FDA | Refreshed Apr 11, 2026, 10:01 AM UTC
Label highlights/doc links are fetched from FDA preview endpoints.
Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Jun 22, 2026, 10:41 AM UTC
Package/product NDCs from FDA’s electronic listing directory (XLS).

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Tilmicosin Phosphate

Drug type: Food-animal record • Branded profile • Livestock/food-animal use

Both Solution Rx required 100% reference complete

Species: Both

Approval status: Food-animal or livestock record. This source record is for livestock or food-animal use, not a dog/cat medication profile. Food-animal rules, withdrawal intervals, and residue restrictions may apply.

Medication Snapshot

Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.

Tilmicosin Phosphate

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni . For the control of respiratory disease in cattle at high risk of developing BRD associated with M. haemolytica . For the treatment of ovine respiratory disease (ORD) associated with Mannheimia haemolytica . For the control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in groups of beef and non-lactating dairy cattle, where active BRD has been diagnosed in at least 10% of the animals in the group. Species commonly shown: Both, Beef, Dairy, excluding female breeding age animals.

Generic name

Tilmicosin Phosphate

Brand names

Micotil™ 300, Pulmotil™ 90, Pulmotil™ AC, Tilmovet® 90

Manufacturer

Multiple FDA labelers

Species

Both, Beef, Dairy, Sheep

Dosage forms

Solution, Liquid, Type A Medicated Article, Aqueous Concentrate

Prescription

Prescription required

Completeness

100%

Validation

Complete

Brand names

Micotil™ 300 Pulmotil™ 90 Pulmotil™ AC Tilmovet® 90 Tilmovet® AC Tilmovet AC Oral Solution Micotil 300 Tilmicosin Phosphate Tilmicosin Tilmovet 90 Type A Medicated Article Pulmotil 90 Pulmotil AC

Dosage forms

Solution Liquid Type A Medicated Article Aqueous Concentrate

Indications / Uses

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica , Pasteurella multocida , and Histophilus somni . For the control of respiratory disease in cattle at high risk of developing BRD associated with M. haemolytica . For the treatment of ovine respiratory disease (ORD) associated with Mannheimia haemolytica . For the control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica , Pasteurella multocida , and Histophilus somni in groups of beef and non-lactating dairy cattle, where active BRD has been diagnosed in at least 10% of the animals in the group.

Warnings / Contraindications

Feed continuously for a single, 14-day period to provide 12.5 mg tilmicosin/kg of body weight/day. The safety of tilmicosin has not been established in cattle intended for breeding purposes. This drug product is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. This drug product is not approved for use in calves intended to be processed for veal. A withdrawal period has not been established in pre-ruminating calves. Cattle intended for human consumption must not be slaughtered within 28 days of the last treatment with this drug product. Feed continuously as the sole ration for 21-day period, beginning approximately 7 days before an anticipated disease outbreak. The safety of tilmicosin has not been established in male swine intended for breeding purposes. Swine intended for human consumption must not be slaughtered within 7 days of the last treatment with this drug product. The safety of tilmicosin has not been established in cattle intended for breeding purposes. Tilmicosin is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. Tilmicosin is not approved for use in calves intended to be processed for veal. Feed only to cattle being fed in confinement for slaughter. Feed continuously for 14 days to provide 12.5 mg tilmicosin/kg/head/day. Tilmicosin is not approved for use in calves intended to be processed for veal. Feed continuously in complete feed at a rate of 50 to 480 milligrams of monensin per head per day. No additional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 grams per ton (360 milligrams per head per day).

Feed continuously for a single, 14-day period to provide 12.5 mg tilmicosin/kg of body weight/day. The safety of tilmicosin has not been established in cattle intended for breeding purposes. This drug product is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. This drug product is not approved for use in calves intended to be processed for veal. A withdrawal period has not been established in pre-ruminating calves. Cattle intended for human consumption must not be slaughtered within 28 days of the last treatment with this drug product. Feed continuously as the sole ration for 21-day period, beginning approximately 7 days before an anticipated disease outbreak. The safety of tilmicosin has not been established in male swine intended for breeding purposes. Swine intended for human consumption must not be slaughtered within 7 days of the last treatment with this drug product. The safety of tilmicosin has not been established in cattle intended for breeding purposes. Tilmicosin is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. Tilmicosin is not approved for use in calves intended to be processed for veal. Feed only to cattle being fed in confinement for slaughter. Feed continuously for 14 days to provide 12.5 mg tilmicosin/kg/head/day. Tilmicosin is not approved for use in calves intended to be processed for veal. Feed continuously in complete feed at a rate of 50 to 480 milligrams of monensin per head per day. No additional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 grams per ton (360 milligrams per head per day).

FAQ

Both, Beef, Dairy, excluding female breeding age animals, Sheep, Beef And Non-Lactating Dairy

Yes. Roxee shows this as prescription-only.

Solution, Liquid, Type A Medicated Article, Aqueous Concentrate

Related Conditions

Pneumonia (aspiration, bacterial, viral)

Source Transparency

Verified source: https://www.roxee.ai/meds/
Verified source: https://animaldrugsatfda.fda.gov
Verified source: https://animaldrugsatfda.fda.gov/adafda/views/#/search
Verified source: https://api.fda.gov/animalandveterinary/event.json
Verified source: https://www.roxee.ai/conditions/
Verified source: https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/600
Last refreshed: Jun 22, 2026, 10:45 a.m.
Last verified: Feb 12, 2026, 10:44 p.m.
Validation status: Complete

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Pet Owner Quick Guide

Start here first for the safest next-step summary before the deeper medication detail.

Used for:

For the control of swine respiratory disease associated with Pasteurella multocida and Haemophilus parasuis in groups of swine in buildings where a respiratory disease outbreak is diagnosed. For the control of swine resp...

Dosing note:

Exact dosing depends on your pet's species, weight, and health status. Use your veterinarian's instructions for the exact dose and schedule.

What to watch for:

Feed continuously for a single, 14-day period to provide 12.5 mg tilmicosin/kg of body weight/day
The safety of tilmicosin has not been established in cattle intended for breeding purposes
This drug product is not approved for use in female dairy cattle 20 months of age or older
Use in these cattle may cause drug residues in milk
This drug product is not approved for use in calves intended to be processed for veal
A withdrawal period has not been established in pre-ruminating calves
Cattle intended for human consumption must not be slaughtered within 28 days of the last treatment with this drug product
Feed continuously as the sole ration for 21-day period, beginning approximately 7 days before an anticipated disease outbreak
The safety of tilmicosin has not been established in male swine intended for breeding purposes
Swine intended for human consumption must not be slaughtered within 7 days of the last treatment with this drug product
Tilmicosin is not approved for use in female dairy cattle 20 months of age or older
Tilmicosin is not approved for use in calves intended to be processed for veal
Feed only to cattle being fed in confinement for slaughter
Feed continuously for 14 days to provide 12.5 mg tilmicosin/kg/head/day
Feed continuously in complete feed at a rate of 50 to 480 milligrams of monensin per head per day
No additional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 grams per ton (360 milligrams per head per day)

When to call the vet:

Repeated vomiting or diarrhea.
Severe lethargy (hard to wake, very low energy).
Collapse or fainting.
Trouble breathing.
Facial swelling or hives.
Blood in vomit or stool.

What to tell or ask your vet today:

Is this medicine the right fit for my pet’s current symptoms?
Which warning signs mean I should call back right away?
How should I handle missed doses or refusal to take the medicine?

Next actions

Talk to a Vet / Find a Vet Near You Save to pet meds Share page Review report evidence

Research brief

Medication Research Insights

A source-aware map of what to know, what is uncertain, and what to verify with your veterinarian.

Source Backed Limited Signals

What to know

Evidence-backed context Limited

Roxee has limited cited overview evidence for Tilmicosin Phosphate; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA adverse-event data

Safety signal coverage No signal rollup

No source-backed adverse-reaction rollup is linked yet. That is a data gap, not proof that no reactions occur.

Source: openFDA adverse-event data

Interpretation guardrail Not causation

Adverse-event reports help form a watch list, but they do not prove the medication caused the reaction and they are not a risk ranking between medications.

Evidence tension

Stronger signal Label / review

Official labels, package inserts, and reviewed summaries carry more weight than isolated reports.

Source: openFDA adverse-event data

Weaker signal Reported data

Case reports and openFDA terms are useful for pattern awareness, but they are incomplete, can include multiple exposures, and do not estimate an individual pet's probability of harm.

Reaction signal map

Reaction signal map Limited data

No source-backed adverse-reaction rollup is linked yet for this medication. Use the owner watch list, official documents, and veterinary guidance.

What your vet may verify

Fit for this patient Vet check

Verify whether Tilmicosin Phosphate fits the pet's species, current diagnosis, age, weight, organ status, pregnancy/lactation status, and concurrent medications.

Evidence limitations Evidence review

Separate label-backed warnings from adverse-event reports and owner observations before changing the plan.

What to watch next

Watch list Owner-safe

Feed continuously for a single, 14-day period to provide 12.5 mg tilmicosin/kg of body weight/day, The safety of tilmicosin has not been established in cattle intended for breeding purposes, This drug product is not approved for use in female dairy cattle 20 months of age or older, Use in these cattle may cause drug residues in milk, This drug product is not approved for use in calves intended to be processed for veal

Call sooner if Escalation

Repeated vomiting or diarrhea. Severe lethargy (hard to wake, very low energy). Collapse or fainting.

Bottom line: Roxee has limited reaction-signal depth for Tilmicosin Phosphate right now. Use veterinary instructions, official documents, and direct clinic guidance for decisions.

Vet source depth

openFDA adverse-event data · openfda · adverse reactions
Contraindication source · fda_animal_drugs · warnings contraindications
FDA application profile · official_label · quick facts
FDA application profile · official_label · quick facts
Medication usage source · fda_animal_drugs · quick facts
FOI · document · documents
SPL · document · documents
FOI · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

Updated: February 12, 2026, 10:44 PM UTC

Sources:

FDA application profile · official_label
FDA application profile · official_label
Medication usage source · fda_animal_drugs
Pulmotil™ AC · official_label
openFDA adverse-event data · openfda

Safety & side effects

Side effects to monitor:

Feed continuously for a single, 14-day period to provide 12.5 mg tilmicosin/kg of body weight/day
The safety of tilmicosin has not been established in cattle intended for breeding purposes
This drug product is not approved for use in female dairy cattle 20 months of age or older
Use in these cattle may cause drug residues in milk
This drug product is not approved for use in calves intended to be processed for veal

Emergency warning signs:

Repeated vomiting or diarrhea.
Severe lethargy (hard to wake, very low energy).
Collapse or fainting.
Trouble breathing.

Talk to a Vet / Find a Vet Near You Start Symptom Intake

Vet Fast Scan

Source-backed clinical checkpoints for quick review.

FDA-labeled species

Beef, Beef And Non-Lactating Dairy, Dairy, Sheep

Indication / use

For the control of swine respiratory disease associated with Pasteurella multocida and Haemophilus parasuis in groups of swine in buildings where a respiratory disease outbreak is…

Form / route / dose

Form: Aqueous Concentrate, Liquid, Type A Medicated Article
Route: Oral, Oral, in drinking water, Subcutaneous
Confirm product label and patient-specific plan.

Warnings

High: Feed continuously for a single, 14-day period to provide 12.5 mg tilmicosin/kg of body weight/day. The safety of tilmic…

Adverse-event caveat

No stored openFDA case explorer rows are linked yet.

Source docs

140-929 Official label / PI
140-929 Official label / PI
141-361 Official label / PI

Quick Facts

Official label facts first, then secondary summaries. Marketing content is separated below.

Species: Both

Manufacturer: Multiple FDA labelers

Form: Aqueous Concentrate, Liquid, Type A Medicated Article

Identifiers:

ANADA: 200509 ANADA: 200596 ANADA: 200654 ANADA: 200655 ANADA: 200707 NADA: 140929 NADA: 141064 NADA: 141343 NADA: 141361 NDC Package: 23243-2395-4 NDC Package: 23243-7287-1 NDC Package: 49553-4161-1 NDC Package: 58198-0230-2 NDC Package: 58198-0470-1 NDC Package: 58198-0472-9 NDC Package: 86098-0003-1 NDC Package: 86098-0004-1 NDC Product: 23243 NDC Product: 49553 NDC Product: 58198

Source metadata:

https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/200707 · official_label · FDA application profile
https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/140929 · official_label · FDA application profile
https://animaldrugsatfda.fda.gov · fda_animal_drugs · Medication usage source

Warnings / Contraindications

High: Feed continuously for a single, 14-day period to provide 12.5 mg tilmicosin/kg of body weight/day. The safety of tilmicosin has not been established in cattle intended for breeding purposes. This drug product is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. This drug product is not approved for use in calves intended to be processed for veal. A withdrawal period has not been established in pre-ruminating calves. Cattle intended for human consumption must not be slaughtered within 28 days of the last treatment with this drug product. Feed continuously as the sole ration for 21-day period, beginning approximately 7 days before an anticipated disease outbreak. The safety of tilmicosin has not been established in male swine intended for breeding purposes. Swine intended for human consumption must not be slaughtered within 7 days of the last treatment with this drug product. The safety of tilmicosin has not been established in cattle intended for breeding purposes. Tilmicosin is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. Tilmicosin is not approved for use in calves intended to be processed for veal. Feed only to cattle being fed in confinement for slaughter. Feed continuously for 14 days to provide 12.5 mg tilmicosin/kg/head/day. Tilmicosin is not approved for use in calves intended to be processed for veal. Feed continuously in complete feed at a rate of 50 to 480 milligrams of monensin per head per day. No additional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 grams per ton (360 milligrams per head per day).

Source metadata:

https://animaldrugsatfda.fda.gov · fda_animal_drugs · Contraindication source

Source Documents

The most useful source links appear first; full previews and metadata stay in the veterinary/professional layer.

Use original documents to confirm product-specific warnings, ingredients, and handling details with your veterinarian.

140-929 Official label / PI · EA 140-929 Official label / PI · FONSI 141-361 Official label / PI · EA

Full source previews and metadata remain in the veterinary/professional layer.

Owner handouts

No owner handouts linked yet.

Official label / PI

SPL

Open original

Tilmovet® AC

SPL · SPL

Open original

FDA Structured Product Label

Tilmovet® AC

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor: Huvepharma EOOD
ANADA: 200-707
Status: RX
Form: Aqueous Concentrate
Route: Oral, in drinking water

Composition / specifications

250 mg/mL

Swine

Indication

For the control of swine respiratory disease associated with Pasteurella multocida and Haemophilus parasuis in groups of swine in buildings where a respiratory disease outbreak is diagnosed.

For the control of swine respiratory disease associated with Mycoplasma hyopneumoniae in the presence of Porcine Reproductive and Respiratory Syndrome Virus (PRRSV) in groups of swine in buildings where a respiratory disease outbreak is diagnosed.

Dosage

Administer in drinking water at a concentration of 200 mg tilmicosin per liter for 5 consecutive days.

Micotil™ 300

SPL · SPL

Open original

FDA Structured Product Label

Micotil™ 300

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor: Elanco US Inc.
NADA: 140-929
Status: RX
Form: Liquid
Route: Subcutaneous
Species: Beef • Dairy • Sheep

Composition / specifications

300 mg tilmicosin/mL

Cattle

Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni. For the control of respiratory disease in cattle at high risk of developing BRD associated with M. haemolytica.

Dosage

Administer a single subcutaneous dose of 10 to 20 mg/kg body weight (1 to 2 mL/30 kg or 1.5 to 3 mL per 100 lbs.). Do not inject more than 10 mL per injection site.

Sheep

Indication

For the treatment of ovine respiratory disease (ORD) associated with Mannheimia haemolytica.

Dosage

In sheep greater than 15 kg, administer a single subcutaneous dose of 10 mg/kg of body weight (1 mL/30 kg or 1.5 mL per 100 lbs.). Do not inject more than 10 mL per injection site.

Pulmotil™ AC

SPL · SPL

Open original

FDA Structured Product Label

Pulmotil™ AC

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor: Elanco US Inc.
NADA: 141-361
Status: RX
Form: Aqueous Concentrate
Route: Oral

Composition / specifications

250 mg tilmicosin/mL

Swine

Indication

For the control of swine respiratory disease associated with Pasteurella multocida and Haemophilus parasuis in groups of swine in buildings where a respiratory disease outbreak is diagnosed.

For the control of swine respiratory disease (SRD) associated with Mycoplasma hyopneumoniae in the presence of Porcine Reproductive and Respiratory Syndrome Virus (PRRSV) in groups of swine in buildings where a respiratory disease outbreak is diagnosed.

Dosage

200 mg tilmicosin/L (200 ppm) for 5 consecutive days

Limitations

For use in swine only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not inject this product. Injection of tilmicosin has been shown to be fatal in swine and non-human primates, and may be fatal in horses and goats.

Pulmotil™ 90

SPL · SPL

Open original

FDA Structured Product Label

Pulmotil™ 90

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor: Elanco US Inc.
NADA: 141-064
Status: VFD
Form: Type A Medicated Article
Route: Oral
Species: Beef And Non-Lactating Dairy

Composition / specifications

Tilmicosin (as tilmicosin phosphate) 90.7 g per lb (200 g per kg)

Beef and non-lactating dairy cattle

Indication

For the control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in groups of beef and non-lactating dairy cattle, where active BRD has been diagnosed in at least 10% of the animals in the group.

Dosage

Tilmicosin (as tilmicosin phosphate): 568 to 757 grams per ton (100% dry matter basis) of Type C medicated feed.

Limitations

Swine

Indication

For the control of swine respiratory disease associated with Actinobacillus pleuropneumoniae and Pasteurella multocida.

Dosage

Tilmicosin (as tilmicosin phosphate): 181 to 363 grams per ton of Type C medicated feed.

Limitations

Feed continuously as the sole ration for 21-day period, beginning approximately 7 days before an anticipated disease outbreak. The safety of tilmicosin has not been established in male swine intended for breeding purposes. Swine intended for human consumption must not be slaughtered within 7 days of the last treatment with this drug product.

Tilmovet® 90

SPL · SPL

Open original

FDA Structured Product Label

Tilmovet® 90

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor: Huvepharma EOOD
ANADA: 200-509
Status: VFD
Form: Type A Medicated Article
Route: Oral
Species: Beef And Non-Lactating Dairy

Composition / specifications

Tilmicosin (as tilmicosin phosphate) 90.7 g/lb

Swine

Indication

For the control of swine respiratory disease associated with Actinobacillus pleuropneumoniae and Pasteurella multocida.

Dosage

Tilmicosin is to be fed continuously at 181 grams to 363 grams per ton (200 ppm to 400 ppm) of Type C medicated feed as the sole ration for a 21-day period, beginning approximately 7 days before an anticipated disease outbreak.

Limitations

Do not allow horses or other equines access to feeds containing tilmicosin. The safety of tilmicosin has not been established in cattle or male swine intended for breeding purposes. Feed containing tilmicosin shall not be fed to pigs for more than 21 days during each phase of production without ceasing administration for reevaluation of antimicrobial use by a licensed veterinarian before re-initiating a further course of therapy with an appropriate antimicrobial. Veterinary Feed Directive (VFD) expiration date for swine must not exceed 90 days from the time of issuance. VFDs for tilmicosin shall not be refilled.

Cattle (Beef and Non-Lactating Dairy)

Indication

Dosage

Source metadata:

https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/11894 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/11959/Tilmovet%C2%AE%20AC · document · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/494 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/493 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/492 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/2494 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/2500 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/491 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadEA/177 · document · EA
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFonsi/181 · document · FONSI

Veterinary reference (advanced)

Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.

At a Glance

Quick facts and links to official labeling and safety signals.

Data freshness

Reference facts: Source Roxee | Refreshed Jun 22, 2026, 10:45 AM UTC
The reference fact projection used for browse cards and quick facts.
Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:40 AM UTC
Applications/products are imported from FDA export data.
Animal Drugs @ FDA previews: Source FDA | Refreshed Apr 11, 2026, 10:01 AM UTC
Label highlights/doc links are fetched from FDA preview endpoints.
Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Jun 22, 2026, 10:41 AM UTC
Package/product NDCs from FDA’s electronic listing directory (XLS).

Official (FDA)

Identity: Generic ingredient • FDA branded products available

Official FDA brands: Micotil 300 Pulmotil 90 Pulmotil AC Tilmicosin Tilmicosin Phosphate Tilmovet 90 Type A Medicated Article Tilmovet AC Oral Solution

Manufacturer mapping: Multiple FDA labelers

Catalog species: Both • FDA-labeled species: Beef, Beef And Non-Lactating Dairy, Dairy, Sheep

Rx/OTC: RX, VFD

Form/route: Aqueous Concentrate, Liquid, Type A Medicated Article • Oral, Oral, in drinking water, Subcutaneous

Applications: ANADA 200-707 • NADA 140-929 • NADA 141-361 • NADA 141-064 • ANADA 200-509

NDC: Packages 23243-2395-4 23243-7287-1 49553-4161-1 58198-0230-2 58198-0470-1 58198-0472-9 • Products 23243 49553 58198 86098

Documents: 26 (FOI: 16) • SPL: 5 • Label highlights • Official documents

Safety (openFDA)

Top reactions: Dog 0 • Cat 0

Case summaries: 0

openFDA reports are unverified and do not prove causation.

Explore

Related conditions: Pneumonia (aspiration, bacterial, viral)

Linked using: Fda_Label (0.95)

Diagnosis Codes

Diagnosis-code mappings are not available for this medication yet.

Counseling and Monitoring Highlights

Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.

Owner-facing counseling points

Feed continuously for a single, 14-day period to provide 12.5 mg tilmicosin/kg of body weight/day. The safety of tilmicosin has not been established in cattle intended for breeding purposes. This drug product is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. This drug product is not approved for use in calves intended to be processed for veal. A withdrawal period has not been established in pre-ruminating calves. Cattle intended for human consumption must not be slaughtered within 28 days of the last treatment with this drug product. Feed continuously as the sole ration for 21-day period, beginning approximately 7 days before an anticipated disease outbreak. The safety of tilmicosin has not been established in male swine intended for breeding purposes. Swine intended for human consumption must not be slaughtered within 7 days of the last treatment with this drug product. The safety of tilmicosin has not been established in cattle intended for breeding purposes. Tilmicosin is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. Tilmicosin is not approved for use in calves intended to be processed for veal. Feed only to cattle being fed in confinement for slaughter. Feed continuously for 14 days to provide 12.5 mg tilmicosin/kg/head/day. Tilmicosin is not approved for use in calves intended to be processed for veal. Feed continuously in complete feed at a rate of 50 to 480 milligrams of monensin per head per day. No additional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 grams per ton (360 milligrams per head per day). (Contraindication, High)

Identifiers & Packages

Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.

Identifiers

Package NDC	Product NDC	Status
23243-2395-4	23243	-
23243-7287-1	23243	-
49553-4161-1	49553	-
58198-0230-2	58198	-
58198-0470-1	58198	-
58198-0472-9	58198	-
86098-0003-1	86098	-
86098-0004-1	86098	-

Enriched Documents

Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.

Tilmicosin SPL • Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
Tilmicosin Phosphate SPL • Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
Tilmicosin Phosphate SPL • Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
Micotil 300 SPL • Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
Tilmovet AC Oral Solution SPL • Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
Pulmotil AC SPL • Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
Pulmotil 90 SPL • Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
Tilmovet 90 Type A Medicated Article SPL • Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
FOI Summary oA 200-707 Approved January 25, 2022.pdf • FOI summary • Official • Feb. 1, 2022
FDA FOI summary for application 200707
UCM478248.pdf • FOI summary • Official • April 24, 2020
FDA FOI summary for application 140929
N140929 Supp_12_30_1996_.pdf • FOI summary • Official • April 24, 2020
FDA FOI summary for application 140929
N140929 Supp_12_23_1997.pdf • FOI summary • Official • April 24, 2020
FDA FOI summary for application 140929
ucm115926.pdf • FOI summary • Official • April 24, 2020
FDA FOI summary for application 140929
ucm115928.pdf • FOI summary • Official • April 24, 2020
FDA FOI summary for application 140929
UCM255919.pdf • FOI summary • Official • April 24, 2020
FDA FOI summary for application 140929
FOI Summary oA 200-655 Approved October 11, 2019.pdf • FOI summary • Official • Feb. 24, 2020
FDA FOI summary for application 200655
FOI Summary oA 200-654 Approved October 11, 2019.pdf • FOI summary • Official • Feb. 24, 2020
FDA FOI summary for application 200654
UCM396900.pdf • FOI summary • Official • Oct. 24, 2019
FDA FOI summary for application 141361
UCM480603.pdf • FOI summary • Official • Oct. 24, 2019
FDA FOI summary for application 141361
N141064_Orig_12_17_1996.pdf • FOI summary • Official • Oct. 23, 2019
FDA FOI summary for application 141064
ucm116747.pdf • FOI summary • Official • Oct. 23, 2019
FDA FOI summary for application 141064
ucm116748.pdf • FOI summary • Official • Oct. 23, 2019
FDA FOI summary for application 141064
ucm116750.pdf • FOI summary • Official • Oct. 23, 2019
FDA FOI summary for application 141064
UCM287928.pdf • FOI summary • Official • Oct. 23, 2019
FDA FOI summary for application 141064
UCM504537.pdf • FOI summary • Official • Oct. 3, 2019
FDA FOI summary for application 200596
UCM326885.pdf • FOI summary • Official • Dec. 4, 2018
FDA FOI summary for application 141343
UCM351216.pdf • FOI summary • Official • Nov. 10, 2018
FDA FOI summary for application 200509
UCM461125.pdf • FOI summary • Official • Nov. 10, 2018
FDA FOI summary for application 200509

Data Sources & Change Log

Every non-trivial field is expected to include provenance and update timestamps.

Official 148 Clinical 0 Manufacturer 0 Marketing 0

Current Field Facts

contraindications: Feed continuously for a single, 14-day period to provide 12.5 mg tilmicosin/kg of body weight/day. The safety of tilmicosin has not been established in cattle … (Official, 2026-06-22)
contraindications: Feed continuously for a single, 14-day period to provide 12.5 mg tilmicosin/kg of body weight/day. The safety of tilmicosin has not been established in cattle … (Official, 2026-06-22)
contraindications: Feed continuously for a single, 14-day period to provide 12.5 mg tilmicosin/kg of body weight/day. The safety of tilmicosin has not been established in cattle … (Official, 2026-06-21)
contraindications: Feed continuously for a single, 14-day period to provide 12.5 mg tilmicosin/kg of body weight/day. The safety of tilmicosin has not been established in cattle … (Official, 2026-06-20)
contraindications: Feed continuously for a single, 14-day period to provide 12.5 mg tilmicosin/kg of body weight/day. The safety of tilmicosin has not been established in cattle … (Official, 2026-06-13)
contraindications: Feed continuously for a single, 14-day period to provide 12.5 mg tilmicosin/kg of body weight/day. The safety of tilmicosin has not been established in cattle … (Official, 2026-06-12)
contraindications: Feed continuously for a single, 14-day period to provide 12.5 mg tilmicosin/kg of body weight/day. The safety of tilmicosin has not been established in cattle … (Official, 2026-06-12)
contraindications: Feed continuously for a single, 14-day period to provide 12.5 mg tilmicosin/kg of body weight/day. The safety of tilmicosin has not been established in cattle … (Official, 2026-06-11)
contraindications: Feed continuously for a single, 14-day period to provide 12.5 mg tilmicosin/kg of body weight/day. The safety of tilmicosin has not been established in cattle … (Official, 2026-06-11)
contraindications: Feed continuously for a single, 14-day period to provide 12.5 mg tilmicosin/kg of body weight/day. The safety of tilmicosin has not been established in cattle … (Official, 2026-06-10)
contraindications: Feed continuously for a single, 14-day period to provide 12.5 mg tilmicosin/kg of body weight/day. The safety of tilmicosin has not been established in cattle … (Official, 2026-06-08)
contraindications: Feed continuously for a single, 14-day period to provide 12.5 mg tilmicosin/kg of body weight/day. The safety of tilmicosin has not been established in cattle … (Official, 2026-06-07)
contraindications: Feed continuously for a single, 14-day period to provide 12.5 mg tilmicosin/kg of body weight/day. The safety of tilmicosin has not been established in cattle … (Official, 2026-06-06)
contraindications: Feed continuously for a single, 14-day period to provide 12.5 mg tilmicosin/kg of body weight/day. The safety of tilmicosin has not been established in cattle … (Official, 2026-06-05)
contraindications: Feed continuously for a single, 14-day period to provide 12.5 mg tilmicosin/kg of body weight/day. The safety of tilmicosin has not been established in cattle … (Official, 2026-06-04)
contraindications: Feed continuously for a single, 14-day period to provide 12.5 mg tilmicosin/kg of body weight/day. The safety of tilmicosin has not been established in cattle … (Official, 2026-06-03)
contraindications: Feed continuously for a single, 14-day period to provide 12.5 mg tilmicosin/kg of body weight/day. The safety of tilmicosin has not been established in cattle … (Official, 2026-06-02)
contraindications: Feed continuously for a single, 14-day period to provide 12.5 mg tilmicosin/kg of body weight/day. The safety of tilmicosin has not been established in cattle … (Official, 2026-06-01)
contraindications: Feed continuously for a single, 14-day period to provide 12.5 mg tilmicosin/kg of body weight/day. The safety of tilmicosin has not been established in cattle … (Official, 2026-06-01)
contraindications: Feed continuously for a single, 14-day period to provide 12.5 mg tilmicosin/kg of body weight/day. The safety of tilmicosin has not been established in cattle … (Official, 2026-05-31)

Recent Revisions

contraindications updated 2026-06-22 10:45 by etl_backfill • Backfilled from existing medication fields
usage updated 2026-06-22 10:45 by etl_backfill • Backfilled from existing medication fields
contraindications updated 2026-06-22 10:04 by etl_backfill • Backfilled from existing medication fields
usage updated 2026-06-22 10:04 by etl_backfill • Backfilled from existing medication fields
contraindications updated 2026-06-21 05:18 by etl_backfill • Backfilled from existing medication fields
usage updated 2026-06-21 05:18 by etl_backfill • Backfilled from existing medication fields
contraindications updated 2026-06-20 20:58 by etl_backfill • Backfilled from existing medication fields
usage updated 2026-06-20 20:58 by etl_backfill • Backfilled from existing medication fields
contraindications updated 2026-06-13 11:33 by etl_backfill • Backfilled from existing medication fields
usage updated 2026-06-13 11:33 by etl_backfill • Backfilled from existing medication fields
contraindications updated 2026-06-12 10:42 by etl_backfill • Backfilled from existing medication fields
usage updated 2026-06-12 10:42 by etl_backfill • Backfilled from existing medication fields
contraindications updated 2026-06-12 10:04 by etl_backfill • Backfilled from existing medication fields
usage updated 2026-06-12 10:04 by etl_backfill • Backfilled from existing medication fields
contraindications updated 2026-06-11 19:22 by etl_backfill • Backfilled from existing medication fields
usage updated 2026-06-11 19:22 by etl_backfill • Backfilled from existing medication fields
contraindications updated 2026-06-11 18:40 by etl_backfill • Backfilled from existing medication fields
usage updated 2026-06-11 18:40 by etl_backfill • Backfilled from existing medication fields
contraindications updated 2026-06-10 10:05 by etl_backfill • Backfilled from existing medication fields
usage updated 2026-06-10 10:05 by etl_backfill • Backfilled from existing medication fields

FDA Products & Applications (Animal Drugs @ FDA)

Official sponsor/proprietary-name/application-status records linked by active ingredient.

Product	Sponsor	Application	Status	Published
Tilmovet® AC RX Tilmicosin Phosphate Aqueous Concentrate • Oral, in drinking water Label highlights Official documents	Huvepharma EOOD	ANADA 200-707	Approved	Feb 1, 2022
Micotil™ 300 RX Tilmicosin Phosphate Liquid • Subcutaneous Label highlights Official documents	Elanco US Inc.	NADA 140-929	Approved	Apr 24, 2020
Pulmotil™ AC RX Tilmicosin Tilmicosin Phosphate Aqueous Concentrate • Oral Label highlights Official documents	Elanco US Inc.	NADA 141-361	Approved	Oct 24, 2019
Pulmotil™ 90 VFD Tilmicosin Phosphate Type A Medicated Article • Oral Label highlights Official documents	Elanco US Inc.	NADA 141-064	Approved	Oct 23, 2019
Tilmovet® 90 VFD Tilmicosin Type A Medicated Article • Oral Label highlights Official documents	Huvepharma EOOD	ANADA 200-509	Approved	Nov 10, 2018

Data source: FDA Animal Drugs @ FDA (public search export).

What It's For (FDA Label Highlights)

Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.

Composition / specifications

250 mg/mL

Swine

Indication

For the control of swine respiratory disease associated with Pasteurella multocida and Haemophilus parasuis in groups of swine in buildings where a respiratory disease outbreak is diagnosed.

Dosage

Administer in drinking water at a concentration of 200 mg tilmicosin per liter for 5 consecutive days.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Beef • Dairy • Sheep

Composition / specifications

300 mg tilmicosin/mL

Cattle

Indication

Dosage

Administer a single subcutaneous dose of 10 to 20 mg/kg body weight (1 to 2 mL/30 kg or 1.5 to 3 mL per 100 lbs.). Do not inject more than 10 mL per injection site.

Limitations

Sheep

Indication

For the treatment of ovine respiratory disease (ORD) associated with Mannheimia haemolytica.

Dosage

In sheep greater than 15 kg, administer a single subcutaneous dose of 10 mg/kg of body weight (1 mL/30 kg or 1.5 mL per 100 lbs.). Do not inject more than 10 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Composition / specifications

250 mg tilmicosin/mL

Swine

Indication

For the control of swine respiratory disease associated with Pasteurella multocida and Haemophilus parasuis in groups of swine in buildings where a respiratory disease outbreak is diagnosed.

Dosage

200 mg tilmicosin/L (200 ppm) for 5 consecutive days

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Beef And Non-Lactating Dairy

Composition / specifications

Tilmicosin (as tilmicosin phosphate) 90.7 g per lb (200 g per kg)

Beef and non-lactating dairy cattle

Indication

Dosage

Tilmicosin (as tilmicosin phosphate): 568 to 757 grams per ton (100% dry matter basis) of Type C medicated feed.

Limitations

Swine

Indication

For the control of swine respiratory disease associated with Actinobacillus pleuropneumoniae and Pasteurella multocida.

Dosage

Tilmicosin (as tilmicosin phosphate): 181 to 363 grams per ton of Type C medicated feed.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Beef And Non-Lactating Dairy

Composition / specifications

Tilmicosin (as tilmicosin phosphate) 90.7 g/lb

Swine

Indication

For the control of swine respiratory disease associated with Actinobacillus pleuropneumoniae and Pasteurella multocida.

Dosage

Limitations

Cattle (Beef and Non-Lactating Dairy)

Indication

Dosage

Limitations

Do not allow horses or other equines access to feeds containing tilmicosin. The safety of tilmicosin has not been established in cattle or male swine intended for breeding purposes. Use only in cattle fed in confinement for slaughter. Tilmicosin medicated feed treatment has not been evaluated in cattle with severe clinical disease. Cattle with severe clinical illness should be evaluated for individual treatment with an alternative non-macrolide therapy. The expiration dale tor a tilmicosin Veterinarv Feed Directive (VFD) for cattle must not exceed 45 days from the time of issuance. VFDs for tilmicosin shall not be refilled.

FDA page: Open in Animal Drugs @ FDA

Usage

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica , Pasteurella multocida , and Histophilus somni . For the control of respiratory disease in cattle at high risk of developing BRD associated with M. haemolytica . For the treatment of ovine respiratory disease (ORD) associated with Mannheimia haemolytica . For the control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica , Pasteurella multocida , and Histophilus somni in groups of beef and non-lactating dairy cattle, where active BRD has been diagnosed in at least 10% of the animals in the group.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Adverse Event Case Summaries (openFDA)

These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.

No case-level openFDA reports are linked for this medication yet.

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Overdose Information

No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.

Storage & Handling

No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.

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This medication has not been reviewed by a veterinarian yet.

Medical Disclaimer: The medication details provided on Roxee are for informational purposes only and are not a substitute for professional veterinary advice. Always consult your veterinarian about your pet's specific needs.

Tilmicosin Phosphate

Data freshness

Tilmicosin Phosphate

Medication Snapshot

Tilmicosin Phosphate

Indications / Uses

Warnings / Contraindications

FAQ

What species is this commonly shown for?

Does this usually require a prescription?

What dosage forms are listed?

Related Conditions

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Evidence

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Warnings / Contraindications

Source Documents

Owner handouts

Official label / PI

SPL

FOI

140-929

140-929

141-361

141-361

141-361

141-361

141-064

141-064

141-064

141-064

Tilmovet® AC

Tilmovet® AC

Swine

Micotil™ 300

Micotil™ 300

Cattle

Sheep

Pulmotil™ AC

Pulmotil™ AC

Swine

Pulmotil™ 90

Pulmotil™ 90

Beef and non-lactating dairy cattle

Swine

Tilmovet® 90

Tilmovet® 90

Swine

Cattle (Beef and Non-Lactating Dairy)

Tilmicosin SPL

Tilmicosin Phosphate SPL

Tilmicosin Phosphate SPL

Micotil 300 SPL

Tilmovet AC Oral Solution SPL

Pulmotil AC SPL

Pulmotil 90 SPL

Tilmovet 90 Type A Medicated Article SPL

FOI Summary oA 200-707 Approved January 25, 2022.pdf

UCM255919.pdf

ucm115928.pdf

ucm115926.pdf

N140929 Supp_12_23_1997.pdf

N140929 Supp_12_30_1996_.pdf

UCM478248.pdf

UCM480603.pdf

UCM396900.pdf

UCM287928.pdf

ucm116750.pdf

ucm116748.pdf

ucm116747.pdf