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Roxee Medication Guide

Milbemycin, Lufenuron

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 FDA data linked Rx required Tablet Merck Sharp & Dohme Corp. Official label facts Owner quick guide first
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Data freshness

Reference facts
Reference refreshed
Jun 21, 2026, 5:13 a.m.

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

FDA applications
FDA application data refreshed
Jun 21, 2026, 7:26 p.m.

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

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

Source timing details
Source timing details
  • Reference facts: Source Roxee | Refreshed Jun 21, 2026, 5:13 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Jun 21, 2026, 7:26 PM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
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Milbemycin, Lufenuron

Milbemycin, Lufenuron

Drug type: Generic ingredient • Generic profile • No FDA branded products linked

Both Tablet Rx required 100% reference complete

Species: Both

Manufacturer: Merck Sharp & Dohme Corp.

Medication Snapshot

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

Milbemycin, Lufenuron

For use in dogs and puppies for the prevention of heartworm disease caused by Dirofilaria immitis, for prevention and control of flea populations, control of adult Ancylostoma caninum (hookworm), and removal and control of adult Toxocara canis, Toxascaris leonine (roundworm), and Trichuris vulpis (whipworm) infections. Lufenuron controls flea populations by preventing the development of flea eggs and does not kill adult fleas. Concurrent use of insecticides may be necessary for adequate control of adult fleas. The concurrent use of flavored milbemycin oxime and lufenuron tablets is indicated to kill adult fleas and prevent flea eggs from hatching. Species commonly shown: Both, Dog, Excluding Under 2 Pounds, Dogs and puppies, excluding puppies under 4 weeks age.

Generic name
Milbemycin, Lufenuron
Brand names
Sentinel® Flavor Tabs®
Manufacturer
Merck Sharp & Dohme Corp.
Species
Both, Dog, Dogs and puppies
Dosage forms
Tablet
Prescription
Prescription required
Completeness
100%
Validation
Needs review
Brand names
Sentinel® Flavor Tabs®
Dosage forms
Tablet

Indications / Uses

For use in dogs and puppies for the prevention of heartworm disease caused by Dirofilaria immitis , for prevention and control of flea populations, control of adult Ancylostoma caninum (hookworm), and removal and control of adult Toxocara canis , Toxascaris leonine (roundworm), and Trichuris vulpis (whipworm) infections. Lufenuron controls flea populations by preventing the development of flea eggs and does not kill adult fleas. Concurrent use of insecticides may be necessary for adequate control of adult fleas. The concurrent use of flavored milbemycin oxime and lufenuron tablets is indicated to kill adult fleas and prevent flea eggs from hatching.

Warnings / Contraindications

Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Administer tablets once a month, preferably on the same date each time. All dogs in a household should be treated to achieve maximum efficacy. Do not use in dogs less than 4 weeks of age and less than 2 pounds body weight To ensure adequate absorption, always administer sentinel® flavor tabs® to dogs immediately after or in conjunction with a normal meal..

  • Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Administer tablets once a month, preferably on the same date each time. All dogs in a household should be treated to achieve maximum efficacy. Do not use in dogs less than 4 weeks of age and less than 2 pounds body weight To ensure adequate absorption, always administer sentinel® flavor tabs® to dogs immediately after or in conjunction with a normal meal..

Side Effects

Top reported reactions (openFDA): Intentional misuse, Lack of efficacy (endoparasite) - heartworm, Ataxia, Death, Elevated alanine aminotransferase (ALT), Elevated aspartate aminotransferase (AST).

FAQ

Both, Dog, Excluding Under 2 Pounds, Dogs and puppies, excluding puppies under 4 weeks age

Yes. Roxee shows this as prescription-only.

Tablet

Related Medications

Afoxolaner Same category: Flea & Tick Doxycycline Same category: Flea & Tick Fluralaner 13.64% 12-Week Chew Same category: Flea & Tick Fluralaner Chew Tablets Same category: Flea & Tick Fluralaner Spot-On Solution Same category: Flea & Tick Imidacloprid Same category: Flea & Tick

Related Conditions

Fleas (Flea Infestation) Heartworm Disease

Source Transparency

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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 use in dogs and puppies for the prevention of heartworm disease caused by Dirofilaria immitis , for prevention and control of flea populations, control of adult Ancylostoma caninum (hookworm), and removal and control...

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:

  • Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian
  • Administer tablets once a month, preferably on the same date each time
  • All dogs in a household should be treated to achieve maximum efficacy
  • Do not use in dogs less than 4 weeks of age and less than 2 pounds body weight To ensure adequate absorption, always administer sentinel® flavor tabs® to dogs immediately after or in conjunction with a normal meal
  • Urinary tract infection (1 reports)
  • Unclassifiable adverse event (1 reports)
  • Thrombocytopenia (1 reports)

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 Signals

What to know

Evidence-backed context Limited

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

Source: openFDA case USA-USFDACVM-2025-US-072281
Safety signal coverage Reported signals

32 tracked reaction signals; 31 reported cases; 20 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2025-US-072281
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 case USA-USFDACVM-2025-US-072281
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

Most reported reactions Top terms

Urinary tract infection (1 reports), Unclassifiable adverse event (1 reports), Thrombocytopenia (1 reports), Small liver (1 reports), Respiratory tract infection NOS (1 reports)

Body systems represented Signal grouping

Digestive (3), Neurologic (2), Effectiveness (5), Other (22)

Species and breed lens

Species represented in reports Species lens

Dog (28 reports), Cat (4 reports)

What your vet may verify

Fit for this patient Vet check

Verify whether Milbemycin, Lufenuron 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

Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian, Administer tablets once a month, preferably on the same date each time, All dogs in a household should be treated to achieve maximum efficacy, Do not use in dogs less than 4 weeks of age and less than 2 pounds body weight To ensure adequate ab, Urinary tract infection

Call sooner if Escalation

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

Bottom line: Use this Milbemycin, Lufenuron brief as a structured watch list and source map, not as a reason to start, stop, or change treatment without your veterinarian.
Vet source depth
  1. openFDA case USA-USFDACVM-2025-US-072281 · adverse_reaction · adverse reactions
  2. Contraindication source · fda_animal_drugs · warnings contraindications
  3. FDA application profile · official_label · quick facts
  4. Medication usage source · fda_animal_drugs · quick facts
  5. FOI · document · documents
  6. FOI · document · documents
  7. FOI · document · documents
  8. SPL · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

Updated: April 22, 2026, 10:13 AM UTC

Sources:
Safety & side effects

Side effects to monitor:

  • Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian
  • Administer tablets once a month, preferably on the same date each time
  • All dogs in a household should be treated to achieve maximum efficacy
  • Do not use in dogs less than 4 weeks of age and less than 2 pounds body weight To ensure adequate absorption, always administer sentinel® flavor tabs® to dogs immediately after or in conjunction with a normal meal
  • Urinary tract infection

Most reported reactions:

  • Urinary tract infection (1 reports)
  • Unclassifiable adverse event (1 reports)
  • Thrombocytopenia (1 reports)

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
Dog, Dogs and puppies
Indication / use
For use in dogs and puppies for the prevention of heartworm disease caused by Dirofilaria immitis , for prevention and control of flea populations, control of adult Ancylostoma ca…
Form / route / dose
Form: Tablet
Route: Oral
Confirm product label and patient-specific plan.
Warnings
  • High: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Administer tablets once a m…
Adverse-event caveat
No stored openFDA case explorer rows are linked yet.
Source docs

Quick Facts

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

Species: Both
Manufacturer: Merck Sharp & Dohme Corp.
Form: Tablet
Identifiers:
NADA: 141084 NDC Package: 0061-5350-01 NDC Package: 0061-5350-02 NDC Package: 0061-5351-01 NDC Package: 0061-5351-02 NDC Package: 0061-5352-01 NDC Package: 0061-5352-02 NDC Package: 0061-5353-01 NDC Package: 0061-5353-02 NDC Product: 0061
Source metadata:

Warnings / Contraindications

Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Administer tablets once a month, preferably on the same date each time. All dogs in a household should be treated to achieve maximum efficacy. Do not use in dogs less than 4 weeks of age and less than 2 pounds body weight To ensure adequate absorption, always administer sentinel® flavor tabs® to dogs immediately after or in conjunction with a normal meal..

  • High: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Administer tablets once a month, preferably on the same date each time. All dogs in a household should be treated to achieve maximum efficacy. Do not use in dogs less than 4 weeks of age and less than 2 pounds body weight To ensure adequate absorption, always administer sentinel® flavor tabs® to dogs immediately after or in conjunction with a normal meal..
Source metadata:

Adverse Reactions

Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.

Tap or hover a reaction to see what it means in plain language.

Tracked signals
32
Reported cases
31
Serious reports
20
Species represented
2
Grouped by Body System
Digestive (3) · Vomiting, Drooling, Diarrhea Neurologic (2) · Unsteady walking (ataxia), Tiredness (lethargy) Effectiveness (5) · Lack of efficacy - NOS, Lack of efficacy (endoparasite) - tapeworm, Lack of efficacy (endoparasite) - roundworm NOS Other (22) · Wound, Urinary tract infection, UNPALATABLE
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1

Species coverage: Dog (28) Cat (4)

View detailed reaction table
Reaction Body system Species Seriousness Frequency Reports
Other Dog Non-serious - 1
Digestive Cat Non-serious - 1
Other Dog Serious - 1
Neurologic Dog Non-serious - 1
Other Cat Non-serious - 1
Other Dog Serious - 1
Neurologic Dog Non-serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Cat Non-serious - 1
Other Dog Serious - 1
Other Dog Non-serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Effectiveness Dog Serious - 1
Effectiveness Dog Serious - 1
Effectiveness Dog Non-serious - 1
Effectiveness Dog Non-serious - 1
Effectiveness Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Digestive Cat Non-serious - 1
Digestive Dog Non-serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Unknown - -
Source metadata:

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.

Sentinel® Flavor Tabs® SPL · SPL Sentinel Flavor Tabs SPL SPL · Structured Product Label ucm117024.pdf FOI · FOI

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

Owner handouts

0
No owner handouts linked yet.

Official label / PI

0
No official label or package insert links yet.

SPL

2

FOI

3

Sentinel® Flavor Tabs®

SPL · SPL

Open original
FDA Structured Product Label

Sentinel® Flavor Tabs®

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

Sponsor
Intervet, Inc.
NADA
141-084
Status
RX
Form
Tablet
Route
Oral
Species
Dog • Dogs and puppies
Composition / specifications
Tablets containing: 2.3 milligrams milbemycin oxime/46 milligrams lufenuron, 5.75 milligrams/115 milligrams, 11.5 milligrams/230 milligrams, and 23 milligrams/460 milligrams.

Dogs and Puppies (4 Weeks and Older; 2 Lbs or Greater)

Indication
For use in dogs and puppies for the prevention of heartworm disease caused by Dirofilaria immitis, for prevention and control of flea populations, control of adult Ancylostoma caninum (hookworm), and removal and control of adult Toxocara canis, Toxascaris leonine (roundworm), and Trichuris vulpis (whipworm) infections. Lufenuron controls flea populations by preventing the development of flea eggs and does not kill adult fleas. Concurrent use of insecticides may be necessary for adequate control of adult fleas. The concurrent use of flavored milbemycin oxime and lufenuron tablets is indicated to kill adult fleas and prevent flea eggs from hatching.
Dosage
SENTINEL FLAVOR TABS are given orally, once a month, at the recommended minimum dosage of 0.23 mg/lb (0.5 mg/kg) milbemycin oxime and 4.55 mg/lb (10mg/kg) lufenuron.
Limitations
Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Administer tablets once a month, preferably on the same date each time. All dogs in a household should be treated to achieve maximum efficacy. Do not use in dogs less than 4 weeks of age and less than 2 pounds body weight To ensure adequate absorption, always administer sentinel® flavor tabs® to dogs immediately after or in conjunction with a normal meal..

Sentinel Flavor Tabs SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Sentinel Flavor Tabs. Use the source link for the full official labeling record.

ucm117024.pdf

FOI · FOI

Open original

N141084_Supp_6_17_1998.pdf

FOI · FOI

Open original

N141084_Orig_4_10_1997.pdf

FOI · FOI

Open original
Source metadata:
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 21, 2026, 5:13 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Jun 21, 2026, 7:26 PM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
Official (FDA)
Identity: Generic ingredient • No FDA branded products linked
No official FDA brand rows linked yet for this ingredient.
Manufacturer mapping: Merck Sharp & Dohme Corp.
Catalog species: Both • FDA-labeled species: Dog, Dogs and puppies
Rx/OTC: RX
Form/route: Tablet • Oral
Applications: NADA 141-084
Documents: 3 (FOI: 3) • SPL: 1 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 0 • Cat 0 • View
Case summaries: 0
openFDA reports are unverified and do not prove causation.
Explore
Linked using: Fda_Label (0.95), Fda_Label (0.95)
Diagnosis Codes
ICD10_CM: B74.8 ICD10_CM: B88.1
Other filariases

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
  • Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Administer tablets once a month, preferably on the same date each time. All dogs in a household should be treated to achieve maximum efficacy. Do not use in dogs less than 4 weeks of age and less than 2 pounds body weight To ensure adequate absorption, always administer sentinel® flavor tabs® to dogs immediately after or in conjunction with a normal meal.. (Contraindication, High)
Top reaction signals
Urinary tract infection (1) Unclassifiable adverse event (1) Thrombocytopenia (1) Small liver (1) Respiratory tract infection NOS (1) Paresis (1) Overdose (1) Other abnormal test result NOS (1)

Identifiers & Packages

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

Identifiers
NADA: 141084 NDC Package: 0061-5350-01 NDC Package: 0061-5350-02 NDC Package: 0061-5351-01 NDC Package: 0061-5351-02 NDC Package: 0061-5352-01 NDC Package: 0061-5352-02 NDC Package: 0061-5353-01 NDC Package: 0061-5353-02 NDC Product: 0061
Package NDC Product NDC Form / Route Status
0061-5350-01 0061 -
0061-5350-02 0061 -
0061-5351-01 0061 -
0061-5351-02 0061 -
0061-5352-01 0061 -
0061-5352-02 0061 -
0061-5353-01 0061 -
0061-5353-02 0061 -

Enriched Documents

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

  • Sentinel Flavor Tabs SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • N141084_Orig_4_10_1997.pdf • FOI summary • Official • Aug. 3, 2020
    FDA FOI summary for application 141084
  • N141084_Supp_6_17_1998.pdf • FOI summary • Official • Aug. 3, 2020
    FDA FOI summary for application 141084
  • ucm117024.pdf • FOI summary • Official • Aug. 3, 2020
    FDA FOI summary for application 141084

Data Sources & Change Log

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

Official 70 Clinical 4 Manufacturer 0 Marketing 0
Current Field Facts
  • side_effects: Top reported reactions (openFDA): Intentional misuse, Lack of efficacy (endoparasite) - heartworm, Ataxia, Death, Elevated alanine aminotransferase (ALT), Elev… (Clinical, 2026-04-25)
  • side_effects: Top reported reactions (openFDA): Intentional misuse, Lack of efficacy (endoparasite) - heartworm, Ataxia, Death, Elevated alanine aminotransferase (ALT), Elev… (Clinical, 2026-04-22)
  • side_effects: Top reported reactions (openFDA): Intentional misuse, Lack of efficacy (endoparasite) - heartworm, Ataxia, Death, Elevated alanine aminotransferase (ALT), Elev… (Clinical, 2026-04-15)
  • side_effects: Top reported reactions (openFDA): Intentional misuse, Lack of efficacy (endoparasite) - heartworm, Ataxia, Death, Elevated alanine aminotransferase (ALT), Elev… (Clinical, 2026-04-11)
  • contraindications: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Administer tablets once a month, preferably on the same date each t… (Official, 2026-04-25)
  • contraindications: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Administer tablets once a month, preferably on the same date each t… (Official, 2026-04-22)
  • indications: SENTINEL Tablets are indicated for use in dogs and puppies four weeks of age and older and two pounds body weight or greater, for the prevention of heartworm d… (Official, 2026-06-21)
  • indications: SENTINEL Tablets are indicated for use in dogs and puppies four weeks of age and older and two pounds body weight or greater, for the prevention of heartworm d… (Official, 2026-06-20)
  • indications: SENTINEL Tablets are indicated for use in dogs and puppies four weeks of age and older and two pounds body weight or greater, for the prevention of heartworm d… (Official, 2026-06-13)
  • indications: SENTINEL Tablets are indicated for use in dogs and puppies four weeks of age and older and two pounds body weight or greater, for the prevention of heartworm d… (Official, 2026-06-12)
  • indications: SENTINEL Tablets are indicated for use in dogs and puppies four weeks of age and older and two pounds body weight or greater, for the prevention of heartworm d… (Official, 2026-06-12)
  • indications: SENTINEL Tablets are indicated for use in dogs and puppies four weeks of age and older and two pounds body weight or greater, for the prevention of heartworm d… (Official, 2026-06-11)
  • indications: SENTINEL Tablets are indicated for use in dogs and puppies four weeks of age and older and two pounds body weight or greater, for the prevention of heartworm d… (Official, 2026-06-11)
  • indications: SENTINEL Tablets are indicated for use in dogs and puppies four weeks of age and older and two pounds body weight or greater, for the prevention of heartworm d… (Official, 2026-06-10)
  • indications: SENTINEL Tablets are indicated for use in dogs and puppies four weeks of age and older and two pounds body weight or greater, for the prevention of heartworm d… (Official, 2026-06-09)
  • indications: SENTINEL Tablets are indicated for use in dogs and puppies four weeks of age and older and two pounds body weight or greater, for the prevention of heartworm d… (Official, 2026-06-08)
  • indications: SENTINEL Tablets are indicated for use in dogs and puppies four weeks of age and older and two pounds body weight or greater, for the prevention of heartworm d… (Official, 2026-06-07)
  • indications: SENTINEL Tablets are indicated for use in dogs and puppies four weeks of age and older and two pounds body weight or greater, for the prevention of heartworm d… (Official, 2026-06-06)
  • indications: SENTINEL Tablets are indicated for use in dogs and puppies four weeks of age and older and two pounds body weight or greater, for the prevention of heartworm d… (Official, 2026-06-05)
  • indications: SENTINEL Tablets are indicated for use in dogs and puppies four weeks of age and older and two pounds body weight or greater, for the prevention of heartworm d… (Official, 2026-06-04)
Recent Revisions
  • side_effects updated 2026-04-25 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-25 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-25 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-22 10:13 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-22 10:13 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-22 10:13 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-15 10:04 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-02-12 22:44 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
Sentinel® Flavor Tabs®
RX
Lufenuron Milbemycin Oxime
Tablet • Oral
Label highlights
Official documents
Intervet, Inc. NADA 141-084 Approved Aug 3, 2020

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.

Species: Dog • Dogs and puppies
Composition / specifications
Tablets containing: 2.3 milligrams milbemycin oxime/46 milligrams lufenuron, 5.75 milligrams/115 milligrams, 11.5 milligrams/230 milligrams, and 23 milligrams/460 milligrams.
Dogs and Puppies (4 Weeks and Older; 2 Lbs or Greater)
Indication
For use in dogs and puppies for the prevention of heartworm disease caused by Dirofilaria immitis, for prevention and control of flea populations, control of adult Ancylostoma caninum (hookworm), and removal and control of adult Toxocara canis, Toxascaris leonine (roundworm), and Trichuris vulpis (whipworm) infections. Lufenuron controls flea populations by preventing the development of flea eggs and does not kill adult fleas. Concurrent use of insecticides may be necessary for adequate control of adult fleas. The concurrent use of flavored milbemycin oxime and lufenuron tablets is indicated to kill adult fleas and prevent flea eggs from hatching.
Dosage
SENTINEL FLAVOR TABS are given orally, once a month, at the recommended minimum dosage of 0.23 mg/lb (0.5 mg/kg) milbemycin oxime and 4.55 mg/lb (10mg/kg) lufenuron.
Limitations
Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Administer tablets once a month, preferably on the same date each time. All dogs in a household should be treated to achieve maximum efficacy. Do not use in dogs less than 4 weeks of age and less than 2 pounds body weight To ensure adequate absorption, always administer sentinel® flavor tabs® to dogs immediately after or in conjunction with a normal meal..

FDA page: Open in Animal Drugs @ FDA

Usage

For use in dogs and puppies for the prevention of heartworm disease caused by Dirofilaria immitis , for prevention and control of flea populations, control of adult Ancylostoma caninum (hookworm), and removal and control of adult Toxocara canis , Toxascaris leonine (roundworm), and Trichuris vulpis (whipworm) infections. Lufenuron controls flea populations by preventing the development of flea eggs and does not kill adult fleas. Concurrent use of insecticides may be necessary for adequate control of adult fleas. The concurrent use of flavored milbemycin oxime and lufenuron tablets is indicated to kill adult fleas and prevent flea eggs from hatching.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Administer tablets once a month, preferably on the same date each time. All dogs in a household should be treated to achieve maximum efficacy. Do not use in dogs less than 4 weeks of age and less than 2 pounds body weight To ensure adequate absorption, always administer sentinel® flavor tabs® to dogs immediately after or in conjunction with a normal meal..

Top Reported Reactions (openFDA)

De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).

Digestive
Vomiting (1) • Cat Drooling (1) • Cat Diarrhea (1) • Dog

Showing top 5 for Digestive.

Neurologic
Unsteady walking (1) • Dog Tiredness (1) • Dog

Showing top 5 for Neurologic.

Effectiveness
Lack of efficacy - NOS (1) • Dog Lack of efficacy (endoparasite) - tapeworm (1) • Dog Lack of efficacy (endoparasite) - roundworm NOS (1) • Dog Lack of efficacy (endoparasite) - hookworm (1) • Dog Lack of efficacy (endoparasite) - heartworm (1) • Dog

Showing top 5 for Effectiveness.

Other
Wound (1) • Dog Urinary tract infection (1) • Dog UNPALATABLE (1) • Cat Unclassifiable adverse event (1) • Dog Thrombocytopenia (1) • Dog
Show more (16)
Small liver (1) • Dog Scratching (1) • Cat Respiratory tract infection NOS (1) • Dog Polydipsia (1) • Dog Paresis (1) • Dog Overdose (1) • Dog Other abnormal test result NOS (1) • Dog Musculoskeletal disorder NOS (1) • Dog Intentional misuse (1) • Dog Hind limb paresis (1) • Dog Gall bladder & bile duct disorder NOS (1) • Dog Fracture (1) • Dog Elevated aspartate aminotransferase (1) • Dog Elevated alanine aminotransferase (1) • Dog Death (1) • Dog Conjunctivitis (1) • Dog

Showing top 5 for Other.

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

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.