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Roxee Meds Catalog

Grapiprant

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

Both Catalog complete FDA data linked Rx required Tablet Elanco US Inc. Official label facts Owner quick guide first

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Data freshness

Storefront facts
Catalog refreshed
May 5, 2026, 10:00 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 May 5, 2026, 10:00 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: February 12, 2026

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

Sources:
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Grapiprant

Grapiprant

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

Both Tablet Rx required 100% storefront ready

Species: Both

Manufacturer: Elanco US Inc.

Medication Snapshot

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

Grapiprant

For the control of pain and inflammation associated with osteoarthritis in dogs. Species commonly shown: Both, Dog, No Use Class Stated Or Implied.

Generic name
Grapiprant
Brand names
Galliprant™, Galliprant
Manufacturer
Elanco US Inc.
Species
Both, Dog, No Use Class Stated Or Implied
Dosage forms
Tablet
Prescription
Prescription required
Completeness
100%
Validation
Complete
Brand names
Galliprant™ Galliprant
Dosage forms
Tablet

Indications / Uses

For the control of pain and inflammation associated with osteoarthritis in dogs.

Warnings / Contraindications

For oral use in dogs only.

  • For oral use in dogs only.

Side Effects

Top reported reactions (openFDA): Vomiting, Diarrhoea, Lack of efficacy - NOS, Lethargy (see also Central nervous system depression in 'Neurological'), Elevated alanine aminotransferase (ALT), Death by euthanasia.

FAQ

Both, Dog, No Use Class Stated Or Implied

Yes. Roxee shows this as prescription-only.

Tablet

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 the control of pain and inflammation associated with osteoarthritis in dogs.

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:

  • For oral use in dogs only
  • Discomfort NOS (1 reports)
  • Dehiscence (1 reports)
  • Decreased appetite (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?
Major cautions & emergency warning signs

Side effects to monitor:

  • For oral use in dogs only
  • Discomfort NOS
  • Dehiscence
  • Decreased appetite

Most reported reactions:

  • Discomfort NOS (1 reports)
  • Dehiscence (1 reports)
  • Decreased appetite (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: Elanco US Inc.
Form: Tablet
Identifiers:
NADA: 141455 NDC Package: 58198-5810-1 NDC Package: 58198-5810-2 NDC Package: 58198-5810-3 NDC Package: 58198-5811-1 NDC Package: 58198-5811-2 NDC Package: 58198-5811-3 NDC Package: 58198-5812-1 NDC Package: 58198-5812-2 NDC Package: 58198-5812-3 NDC Product: 58198
Source metadata:

Warnings / Contraindications

For oral use in dogs only.

  • High: For oral use in dogs only.
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
21
Species represented
2
Grouped by Body System
Digestive (3) · Loss of appetite, Drooling, Decreased appetite Neurologic (1) · Clonic seizure Behavior (3) · Biting -aggression, Behavioral disorder (unspecified), Anxiety Other (25) · Ear infection NOS, Discomfort NOS, Difficulty eating NOS
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Other 1 Dog 1
Other 1 Dog 1
Digestive 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Neurologic 1 Dog 1

Species coverage: Dog (28) Cat (4)

View detailed reaction table
Reaction Body system Species Seriousness Frequency Reports
Digestive Dog Non-serious - 1
Other Dog Non-serious - 1
Digestive Dog Non-serious - 1
Other Dog Serious - 1
Other Dog Non-serious - 1
Other Dog Non-serious - 1
Other Dog Serious - 1
Digestive Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Neurologic Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Non-serious - 1
Other Dog Serious - 1
Behavior Dog Serious - 1
Behavior Cat Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Non-serious - 1
Other Dog Non-serious - 1
Behavior Dog Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Cat Non-serious - 1
Other Dog Non-serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Non-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

2

SPL

2

FOI

1

N-141455-C-0045-NL-AA_CIS.pdf

Official label / PI · Labeling

N-141455-C-0055-CS-AA_PI.pdf

Official label / PI · Labeling

Galliprant™

SPL · SPL

FDA Structured Product Label

Galliprant™

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
141-455
Status
RX
Form
Tablet
Route
Oral
Species
Dog, No Use Class Stated Or Implied
Composition / specifications
20 mg, 60 mg, or 100 mg

Dogs

Indication
For the control of pain and inflammation associated with osteoarthritis in dogs.
Dosage
0.9 mg/lb (2 mg/kg) once daily.
Limitations
For oral use in dogs only.

Galliprant SPL

SPL · Structured Product Label

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

UCM494127.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 May 5, 2026, 10:00 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: Galliprant
Manufacturer mapping: Elanco US Inc.
Case-reported brands (openFDA): MSK
Catalog species: Both FDA-labeled species: Dog
Rx/OTC: RX
Form/route: Tablet Oral
Applications: NADA 141-455
NDC: Packages 58198-5810-1 58198-5810-2 58198-5810-3 58198-5811-1 58198-5811-2 58198-5811-3 Products 58198
Documents: 3 (FOI: 1) • SPL: 1 Label highlights Official documents
Safety (openFDA)
Top reactions: Dog 133 Cat 0 View
Case summaries: 15 (showing 8) View
openFDA reports are unverified and do not prove causation.

Explore
Linked using: Fda_Label (0.95), Fda_Label (0.95), Fda_Label (0.95)

Diagnosis Codes
ICD10_CM: M19.90
Unspecified osteoarthritis, unspecified site

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
  • For oral use in dogs only. (Contraindication, High)
Top reaction signals
Discomfort NOS (1) Dehiscence (1) Decreased appetite (1) Death by euthanasia (1) Death (1) Corneal ulcer (1) Confusion (1) Clonic seizure (1)

Identifiers & Packages

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

Identifiers
NADA: 141455 NDC Package: 58198-5810-1 NDC Package: 58198-5810-2 NDC Package: 58198-5810-3 NDC Package: 58198-5811-1 NDC Package: 58198-5811-2 NDC Package: 58198-5811-3 NDC Package: 58198-5812-1 NDC Package: 58198-5812-2 NDC Package: 58198-5812-3 NDC Product: 58198
Package NDC Product NDC Form / Route Status
58198-5810-1 58198 -
58198-5810-2 58198 -
58198-5810-3 58198 -
58198-5811-1 58198 -
58198-5811-2 58198 -
58198-5811-3 58198 -
58198-5812-1 58198 -
58198-5812-2 58198 -
58198-5812-3 58198 -

Enriched Documents

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

  • Galliprant SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • N-141455-C-0055-CS-AA_PI.pdf • Official label • Official • July 15, 2025
    FDA official labeling for application 141455
  • N-141455-C-0045-NL-AA_CIS.pdf • Official label • Official • July 15, 2025
    FDA official labeling for application 141455
  • UCM494127.pdf • FOI summary • Official • July 15, 2025
    FDA FOI summary for application 141455

Data Sources & Change Log

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

Official 39 Clinical 1 Manufacturer 0 Marketing 0
Current Field Facts
  • side_effects: Top reported reactions (openFDA): Vomiting, Diarrhoea, Lack of efficacy - NOS, Lethargy (see also Central nervous system depression in 'Neurological'), Elevate… (Clinical, 2026-04-11)
  • contraindications: For oral use in dogs only. (Official, 2026-04-12)
  • contraindications: For oral use in dogs only. (Official, 2026-04-11)
  • contraindications: For oral use in dogs only. (Official, 2026-02-12)
  • indications: For the control of pain and inflammation associated with osteoarthritis in dogs. (Official, 2026-05-05)
  • indications: For the control of pain and inflammation associated with osteoarthritis in dogs. (Official, 2026-05-03)
  • indications: For the control of pain and inflammation associated with osteoarthritis in dogs. (Official, 2026-05-02)
  • indications: For the control of pain and inflammation associated with osteoarthritis in dogs. (Official, 2026-04-29)
  • indications: For the control of pain and inflammation associated with osteoarthritis in dogs. (Official, 2026-04-28)
  • indications: For the control of pain and inflammation associated with osteoarthritis in dogs. (Official, 2026-04-27)
  • indications: For the control of pain and inflammation associated with osteoarthritis in dogs. (Official, 2026-04-26)
  • indications: For the control of pain and inflammation associated with osteoarthritis in dogs. (Official, 2026-04-25)
  • indications: For the control of pain and inflammation associated with osteoarthritis in dogs. (Official, 2026-04-22)
  • manufacturer_name: Elanco US Inc. (Official, 2026-05-05)
  • manufacturer_name: Elanco US Inc. (Official, 2026-05-03)
  • manufacturer_name: Elanco US Inc. (Official, 2026-05-02)
  • manufacturer_name: Elanco US Inc. (Official, 2026-04-29)
  • manufacturer_name: Elanco US Inc. (Official, 2026-04-28)
  • manufacturer_name: Elanco US Inc. (Official, 2026-04-27)
  • manufacturer_name: Elanco US Inc. (Official, 2026-04-26)
Recent Revisions
  • side_effects updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage 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
  • contraindications updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
  • usage 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
Galliprant™
RX
Grapiprant
Tablet Oral
Elanco US Inc. NADA 141-455 Approved Jul 15, 2025

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
20 mg, 60 mg, or 100 mg
Dogs
Indication
For the control of pain and inflammation associated with osteoarthritis in dogs.
Dosage
0.9 mg/lb (2 mg/kg) once daily.
Limitations
For oral use in dogs only.

FDA page: Open in Animal Drugs @ FDA

Usage

For the control of pain and inflammation associated with osteoarthritis in dogs.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

For oral use in dogs only.

Top Reported Reactions (openFDA)

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

Digestive
Loss of appetite (1) • Dog Drooling (1) • Dog Decreased appetite (1) • Dog

Showing top 5 for Digestive.

Neurologic
Clonic seizure (1) • Dog

Showing top 5 for Neurologic.

Behavior
Biting -aggression (1) • Dog Behavioral disorder (1) • Cat Anxiety (1) • Dog

Showing top 5 for Behavior.

Other
Ear infection NOS (1) • Dog Discomfort NOS (1) • Dog Difficulty eating NOS (1) • Dog Dental discolouration (1) • Dog Dehiscence (1) • Dog
Show more (20)
Death by euthanasia (1) • Dog Death (1) • Dog Corneal ulcer (1) • Dog Confusion (1) • Dog Chewing disorder (1) • Dog Bumping into walls (1) • Dog Bradycardia (1) • Dog Bone and joint disorder NOS (1) • Dog Balance problem (1) • Dog Bacterial skin infection NOS (1) • Dog Arthritis (1) • Dog Arrhythmia (1) • Dog Anaemia NOS (1) • Cat Agitation (1) • Cat Accidental exposure (1) • Cat Abnormal ultrasound finding (1) • Dog Abnormal tail posture (1) • Dog Abnormal radiograph finding (1) • Dog Abnormal histology NOS (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.

Dog, Siberian Husky, Female, 11 year, 26.58 kilogram • Drug: MSK, Tablet, Oral, Dose: 1 tablet per animal • Reactions: Clonic seizure, Biting -aggression, Partial blindness, Seizure NOS, Foaming at the mouth… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-075044
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 11.00 Year
  • Weight: 26.580 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
  • Dose: 1 tablet per animal
Reactions Reported:
Clonic seizure Biting -aggression Partial blindness Seizure NOS Foaming at the mouth Oral bleeding Tiredness (lethargy) Wobbliness Unable to focus Urination Lateral recumbency Vocalisation Balance problem Staring Elevated alanine aminotransferase Elevated serum alkaline phosphatase
Outcomes: Ongoing

Dog, Dog (unknown), Unknown • Drug: MSK, Tablet, Unknown • Reactions: Spinal pain NOS, Painful defecation, Not eating, Not drinking • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074815
  • Serious AE: No
  • Treated For AE: No
  • Sex: Unknown
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Tablet
Reactions Reported:
Spinal pain NOS Painful defecation Not eating Not drinking
Outcomes: Ongoing

Dog, Crossbred Canine/dog, Male, 12 year, 30.119 kilogram • Drug: MSK, Tablet, chewable, Unknown • Reactions: Not eating, Vomiting, Lymphadenopathy, Halitosis, Low platelet count… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-075413
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 12.00 Year
  • Weight: 30.119 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Tablet, chewable
Reactions Reported:
Not eating Vomiting Lymphadenopathy Halitosis Low platelet count Elevated alanine aminotransferase Elevated serum alkaline phosphatase Anxiety
Outcomes: Ongoing

Dog, Shepherd Dog - German, Male, 12 year, 35.38 kilogram • Drug: MSK, Tablet, Unknown, Dose: 1 tablet per animal, Frequency: 1 per day • Reactions: Increased appetite, Flatulence • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-074700
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 12.00 Year
  • Weight: 35.380 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Tablet
  • Dose: 1 tablet per animal
  • Frequency: 1 per day
Reactions Reported:
Increased appetite Flatulence
Outcomes: Outcome Unknown

Dog, Retriever - Labrador, Male, 11.08 year, 30.5 kilogram • Drug: MSK, Tablet, Oral, Dose: 1 tablet per animal, Frequency: 1 per day • Reactions: Ear infection NOS, Loss of appetite, Nausea, Vomiting, Polycythaemia… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074697
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 11.08 Year
  • Weight: 30.500 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
  • Dose: 1 tablet per animal
  • Frequency: 1 per day
Reactions Reported:
Ear infection NOS Loss of appetite Nausea Vomiting Polycythaemia Elevated haemoglobin Increased percentage reticulocytes Elevated mean corpuscular volume Elevated alanine aminotransferase Elevated serum alkaline phosphatase Elevated gamma-glutamyl transferase Elevated cholesterol Hyperproteinaemia Elevated total bilirubin Elevated blood urea nitrogen Abnormal ultrasound finding Abnormal histology NOS Other abnormal test result NOS
Outcomes: Ongoing

Dog, Dog (unknown), Unknown • Drug: MSK, Tablet, Unknown • Reactions: Lack of efficacy - NOS • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-074691
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Unknown
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Tablet
Reactions Reported:
Lack of efficacy - NOS
Outcomes: Outcome Unknown

Dog, ['Terrier - Scottish', 'Dog (unknown)'], Male, 16 year, 11.249 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Restlessness, Staring, Confusion, Difficulty eating NOS, Anxiety… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074497
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 16.00 Year
  • Weight: 11.249 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Restlessness Staring Confusion Difficulty eating NOS Anxiety Elevated blood urea nitrogen Elevated serum alkaline phosphatase
Outcomes: Ongoing

Dog, ['Terrier (unspecified)', 'Dog (unknown)'], Male, 14 year, 9.072 kilogram • Drug: MSK, Tablet, chewable, Oral • Reactions: Death, Seizure NOS, Renal failure, Anaemia NOS, Loss of appetite… • Outcome: Died

  • Report ID: USA-USFDACVM-2025-US-074272
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 14.00 Year
  • Weight: 9.072 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
Reactions Reported:
Death Seizure NOS Renal failure Anaemia NOS Loss of appetite Sleepiness - systemic disorder Confusion Shaking Unable to rise Bumping into walls Corneal ulcer Increased drinking Squinting Ocular discharge Biting -aggression Elevated alanine aminotransferase Medication error NOS General illness
Outcomes: Died

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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