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Roxee Meds Catalog

Orbiflox/Momet/Posaco Eardrops

Medication catalog facts with explicit FDA-approval, off-label, source-limited, and safety context.

Both Catalog complete FDA data linked Rx required Topical Suspension Merck Sharp & Dohme Corp. Official label facts Owner quick guide first

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Data freshness

Storefront facts
Catalog refreshed
Apr 22, 2026, 10:07 a.m.

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

FDA applications
FDA application data refreshed
May 5, 2026, 10:00 a.m.

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

Safety reports
Safety data refreshed
May 5, 2026, 10:01 a.m.

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

Source timing details
Source timing details
  • Storefront facts: Source Roxee | Refreshed Apr 22, 2026, 10:07 AM UTC
    The storefront fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed May 5, 2026, 10:00 AM 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.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC

Evidence

Reviewed / Updated / Sources

Reviewed by: Not available

Last reviewed: April 22, 2026

Updated: April 22, 2026, 10:06 AM UTC

Sources:
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Orbiflox/Momet/Posaco Eardrops

Orbiflox/Momet/Posaco Eardrops

Drug type: Generic ingredient • Branded profile FDA branded products available

Both Topical Suspension Rx required 100% storefront ready

Species: Both

Manufacturer: Merck Sharp & Dohme Corp.

Medication Snapshot

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

Orbiflox/Momet/Posaco Eardrops

POSATEX Otic Suspension is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria (coagulase positive staphylococci, Pseudomonas aeruginosa , and Enterococcus faecalis ). Species commonly shown: Both, Dog, No Use Class Stated Or Implied.

Generic name
Orbiflox/Momet/Posaco Eardrops
Brand names
Posatex® Otic Suspension, Posatex
Manufacturer
Merck Sharp & Dohme Corp.
Species
Both, Dog, No Use Class Stated Or Implied
Dosage forms
Topical Suspension
Prescription
Prescription required
Completeness
100%
Validation
Complete
Brand names
Posatex® Otic Suspension Posatex
Dosage forms
Topical Suspension

Indications / Uses

POSATEX Otic Suspension is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria (coagulase positive staphylococci, Pseudomonas aeruginosa , and Enterococcus faecalis ).

Warnings / Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Side Effects

Top reported reactions (openFDA): Deafness, Partial deafness, Drug administration duration too long, Underdose, Lack of efficacy - NOS, Overdose.

FAQ

Both, Dog, No Use Class Stated Or Implied

Yes. Roxee shows this as prescription-only.

Topical Suspension

Related Conditions

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:

POSATEX Otic Suspension is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria (coagulase positive staphylococci, Pseudomonas aerug...

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:

  • wobbly/unsteady walking (1 reports)
  • Injection site pain (1 reports)
  • Injection site oedema (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.

Regulatory restrictions are shown in Vet View.

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?
Major cautions & emergency warning signs

Side effects to monitor:

  • wobbly/unsteady walking
  • Injection site pain
  • Injection site oedema

Most reported reactions:

  • Unsteady walking (ataxia) (1 reports)
  • Injection site pain (1 reports)
  • Injection site oedema (1 reports)

Emergency warning signs:

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

Quick Facts

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

Species: Both
Manufacturer: Merck Sharp & Dohme Corp.
Form: Topical Suspension
Identifiers:
NADA: 141266 NDC Package: 0061-0089-01 NDC Package: 0061-0089-02 NDC Package: 0061-0089-03 NDC Product: 0061
Source metadata:

Warnings / Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • High: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
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
32
Serious reports
28
Species represented
2
Grouped by Body System
Digestive (1) · Decreased appetite Skin & allergy (1) · Application site hair loss Neurologic (1) · Unsteady walking (ataxia) Behavior (1) · Behavioral disorder (unspecified) Other (28) · Injection site pain, Injection site oedema, Injection site mass NOS
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Neurologic 1 Cat 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 (21) Cat (11)

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

Documents

Owner handouts and official technical documents open on-page first, with the original source still one click away.

Owner handouts

0
No owner handouts linked yet.

Official label / PI

0
No official label or package insert links yet.

SPL

2

FOI

1

Posatex® Otic Suspension

SPL · SPL

FDA Structured Product Label

Posatex® Otic Suspension

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
141-266
Status
RX
Form
Topical Suspension
Route
Otic
Species
Dog, No Use Class Stated Or Implied
Composition / specifications
Each gram of POSATEX Otic Suspension contains 10 mg orbifloxacin; mometasone furoate monohydrate equivalent to 1 mg mometasone furoate; and 1 mg posaconazole in a mineral oil based system containing a plasticized hydrocarbon gel.

Dogs

Indication
POSATEX Otic Suspension is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (coagulase positive staphylococci, Pseudomonas aeruginosa, and Enterococcus faecalis).
Dosage
For dogs weighing less than 30 lbs. instill 4 drops of POSATEX Otic Suspension once daily into the ear canal. For dogs weighing 30 lbs. or more, instill 8 drops once daily into the ear canal. Therapy should continue for 7 consecutive days. Four drops of POSATEX Otic Suspension delivers approximately 1.0 mg of orbifloxacin, 0.1 mg of mometasone furoate monohydrate, and 0.1 mg of posaconazole.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Posatex SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Posatex. Use the source link for the full official labeling record.

UCM256757.pdf

FOI · FOI

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
  • Storefront facts: Source Roxee | Refreshed Apr 22, 2026, 10:07 AM UTC
    The storefront fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed May 5, 2026, 10:00 AM 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.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: Posatex
Manufacturer mapping: Merck Sharp & Dohme Corp.
Case-reported brands (openFDA): MSK
Catalog species: Both FDA-labeled species: Dog
Rx/OTC: RX
Form/route: Topical Suspension Otic
Applications: NADA 141-266
NDC: Packages 0061-0089-01 0061-0089-02 0061-0089-03 Products 0061
Documents: 1 (FOI: 1) • SPL: 1 Label highlights Official documents
Safety (openFDA)
Top reactions: Dog 24 Cat 14 View
Case summaries: 5 (showing 5) View
openFDA reports are unverified and do not prove causation.

Explore
Related conditions: Otitis Externa (Ear Infection)
Linked using: Fda_Label (0.95)

Diagnosis Codes
ICD10_CM: H60.90
Otitis externa, unspecified ear

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 law restricts this drug to use by or on the order of a licensed veterinarian. (Contraindication, High)
Top reaction signals
Unsteady walking (ataxia) (1) Injection site pain (1) Injection site oedema (1) Injection site mass NOS (1) Injection site inflammation (1) Injection site haemorrhage (1) Increased skin sensitivity (1) Hyperkalaemia (1)

Identifiers & Packages

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

Identifiers
NADA: 141266 NDC Package: 0061-0089-01 NDC Package: 0061-0089-02 NDC Package: 0061-0089-03 NDC Product: 0061
Package NDC Product NDC Form / Route Status
0061-0089-01 0061 -
0061-0089-02 0061 -
0061-0089-03 0061 -

Enriched Documents

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

  • Posatex SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • UCM256757.pdf • FOI summary • Official • March 23, 2020
    FDA FOI summary for application 141266

Data Sources & Change Log

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

Official 33 Clinical 2 Manufacturer 0 Marketing 0
Current Field Facts
  • side_effects: Top reported reactions (openFDA): Deafness, Partial deafness, Drug administration duration too long, Underdose, Lack of efficacy - NOS, Overdose. (Clinical, 2026-04-15)
  • side_effects: Top reported reactions (openFDA): Deafness, Partial deafness, Drug administration duration too long, Underdose, Lack of efficacy - NOS, Overdose. (Clinical, 2026-04-11)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. (Official, 2026-04-22)
  • indications: POSATEX Otic Suspension is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and ba… (Official, 2026-05-05)
  • indications: POSATEX Otic Suspension is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and ba… (Official, 2026-05-03)
  • indications: POSATEX Otic Suspension is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and ba… (Official, 2026-05-02)
  • indications: POSATEX Otic Suspension is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and ba… (Official, 2026-04-29)
  • indications: POSATEX Otic Suspension is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and ba… (Official, 2026-04-28)
  • indications: POSATEX Otic Suspension is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and ba… (Official, 2026-04-27)
  • indications: POSATEX Otic Suspension is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and ba… (Official, 2026-04-26)
  • indications: POSATEX Otic Suspension is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and ba… (Official, 2026-04-25)
  • indications: POSATEX Otic Suspension is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and ba… (Official, 2026-04-22)
  • manufacturer_name: Merck Sharp & Dohme Corp. (Official, 2026-05-05)
  • manufacturer_name: Merck Sharp & Dohme Corp. (Official, 2026-05-03)
  • manufacturer_name: Merck Sharp & Dohme Corp. (Official, 2026-05-02)
  • manufacturer_name: Merck Sharp & Dohme Corp. (Official, 2026-04-29)
  • manufacturer_name: Merck Sharp & Dohme Corp. (Official, 2026-04-28)
  • manufacturer_name: Merck Sharp & Dohme Corp. (Official, 2026-04-27)
  • manufacturer_name: Merck Sharp & Dohme Corp. (Official, 2026-04-26)
  • manufacturer_name: Merck Sharp & Dohme Corp. (Official, 2026-04-25)
Recent Revisions
  • side_effects updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-22 10:07 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
Posatex® Otic Suspension
RX
Mometasone Furoate Monohydrate Orbifloxacin posaconazole
Topical Suspension Otic
Intervet, Inc. NADA 141-266 Approved Mar 23, 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, No Use Class Stated Or Implied
Composition / specifications
Each gram of POSATEX Otic Suspension contains 10 mg orbifloxacin; mometasone furoate monohydrate equivalent to 1 mg mometasone furoate; and 1 mg posaconazole in a mineral oil based system containing a plasticized hydrocarbon gel.
Dogs
Indication
POSATEX Otic Suspension is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (coagulase positive staphylococci, Pseudomonas aeruginosa, and Enterococcus faecalis).
Dosage
For dogs weighing less than 30 lbs. instill 4 drops of POSATEX Otic Suspension once daily into the ear canal. For dogs weighing 30 lbs. or more, instill 8 drops once daily into the ear canal. Therapy should continue for 7 consecutive days. Four drops of POSATEX Otic Suspension delivers approximately 1.0 mg of orbifloxacin, 0.1 mg of mometasone furoate monohydrate, and 0.1 mg of posaconazole.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Usage

POSATEX Otic Suspension is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria (coagulase positive staphylococci, Pseudomonas aeruginosa , and Enterococcus faecalis ).

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Top Reported Reactions (openFDA)

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

Digestive
Decreased appetite (1) • Cat

Showing top 5 for Digestive.

Skin & allergy
Application site hair loss (1) • Cat

Showing top 5 for Skin & allergy.

Neurologic
Unsteady walking (1) • Cat

Showing top 5 for Neurologic.

Behavior
Behavioral disorder (1) • Dog

Showing top 5 for Behavior.

Other
Injection site pain (1) • Dog Injection site oedema (1) • Dog Injection site mass NOS (1) • Dog Injection site inflammation (1) • Dog Injection site haemorrhage (1) • Dog
Show more (23)
Increased skin sensitivity (1) • Dog Hyperkalaemia (1) • Dog Hiding (1) • Cat Gastric ulceration NOS (1) • Dog Gait abnormality (1) • Cat Eosinopenia (1) • Dog Elevated creatine-kinase (1) • Dog Drug administration duration too long (1) • Dog Dehiscence (1) • Dog Death by euthanasia (1) • Cat Death (1) • Dog Deafness (1) • Dog Cardiac murmur (1) • Cat Bone marrow disorder NOS (1) • Dog Blood loss NOS (1) • Cat Bacterial skin infection NOS (1) • Dog Azotaemia (1) • Cat Application site pustule (1) • Cat Appearance, Abnormal (1) • Cat Adrenal gland disorder NOS (1) • Dog Administration error NOS (1) • Dog Abnormal radiograph finding (1) • Dog Abnormal cytology (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.

Cat, Persian, Male, 12.5 year, 4.4 kilogram • Drug: MSK, Liquid, Oral • Reactions: Intentional misuse, Lack of efficacy - NOS, Death by euthanasia, Gait abnormality, Lumbar pain • Outcome: Euthanized

  • Report ID: USA-USFDACVM-2025-US-075165
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 12.50 Year
  • Weight: 4.400 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Liquid
Reactions Reported:
Intentional misuse Lack of efficacy - NOS Death by euthanasia Gait abnormality Lumbar pain
Outcomes: Euthanized

Dog, ['Retriever - Labrador', 'Dog (unknown)'], Female, 11 year • Drug: MSK, Liquid, Oral • Reactions: Vocalisation, Injection site pain, Increased skin sensitivity, Injection site inflammation, Injection site reddening… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-072652
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 11.00 Year
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Liquid
Reactions Reported:
Vocalisation Injection site pain Increased skin sensitivity Injection site inflammation Injection site reddening Leucocytosis NOS Neutrophilia Monocytosis Eosinopenia Thrombocytosis Hyperkalaemia Low sodium-potassium ratio Elevated creatine-kinase Low thyroxine Abnormal cytology Panniculitis Abnormal radiograph finding Sleep disturbance NOS Necrotic wound Injection site oedema Injection site haemorrhage Dehiscence Bacterial skin infection NOS Injection site mass NOS
Outcomes: Ongoing

Cat, Domestic Shorthair, Male, 5 year, 5.897 kilogram • Drug: MSK, Ophthalmic • Reactions: Weight loss, Decreased appetite, Vomiting • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-072145
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 5.00 Year
  • Weight: 5.897 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Ophthalmic
Reactions Reported:
Weight loss Decreased appetite Vomiting
Outcomes: Ongoing

Cat, Domestic Shorthair, Female, 9 year, 3.83 kilogram • Drug: MSK, Unknown • Reactions: Not eating, Less social, Reluctant to move, Hiding, Not drinking • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-069698
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 9.00 Year
  • Weight: 3.830 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Not eating Less social Reluctant to move Hiding Not drinking
Outcomes: Recovered/Normal

Cat, Domestic Shorthair, Female, 10 year, 2.54 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Lack of efficacy - NOS, Non-regenerative anaemia • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-063054
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 10.00 Year
  • Weight: 2.540 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Lack of efficacy - NOS Non-regenerative anaemia
Outcomes: Ongoing

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.

Share Your Thoughts

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