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Roxee Meds Catalog

Dexmedetomidine

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

Both Catalog complete FDA data linked Rx required Liquid (Solution) Multiple FDA sponsors 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.
  • 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 15, 2026

Updated: April 15, 2026, 10:04 AM UTC

Sources:
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Dexmedetomidine

Dexmedetomidine

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

Both Liquid (Solution) Rx required 100% storefront ready

Species: Both

Manufacturer: Multiple FDA sponsors

Medication Snapshot

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

Dexmedetomidine

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. For use as a preanesthetic to general anesthesia. For use as a sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. Species commonly shown: Both, Dog, No Use Class Stated Or Implied, Cat, No Use Class Stated Or Implied.

Generic name
Dexmedetomidine
Brand names
Dexdomitor®, Dexmedesed®, DEXVETRA™, Dexmedetomidine Hydrochloride
Manufacturer
Multiple FDA sponsors
Species
Both, Dog, No Use Class Stated Or Implied, Cat, No Use Class Stated Or Implied
Dosage forms
Liquid (Solution), Sterile Solution, Injectable Solution, Sterile Injectable Solution
Prescription
Prescription required
Completeness
100%
Validation
Complete
Brand names
Dexdomitor® Dexmedesed® DEXVETRA™ Dexmedetomidine Hydrochloride DexmedVet™ SILEO®
Dosage forms
Liquid (Solution) Sterile Solution Injectable Solution Sterile Injectable Solution Oromucosal Gel

Indications / Uses

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. For use as a preanesthetic to general anesthesia. For use as a sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures.

Warnings / Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue. Federal law (USA) 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. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue. Federal law (USA) restricts this drug to use by or on the order of a licensed veterinarian.

Side Effects

Top reported reactions (openFDA): Lack of efficacy - NOS, Vomiting, Injection site swelling, Death, Bradycardia, Diarrhoea.

FAQ

Both, Dog, No Use Class Stated Or Implied, Cat, No Use Class Stated Or Implied

Yes. Roxee shows this as prescription-only.

Liquid (Solution), Sterile Solution, Injectable Solution, Sterile Injectable Solution

Related Conditions

Shock (hypovolemic, septic, cardiogenic, anaphylactic)

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 as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures.

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:

  • Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue
  • Federal law (USA) restricts this drug to use by or on the order of a licensed veterinarian
  • Loss of appetite (1 reports)
  • Decreased activity (1 reports)
  • Death by euthanasia (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:

  • Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue
  • Federal law (USA) restricts this drug to use by or on the order of a licensed veterinarian
  • Loss of appetite
  • Decreased activity
  • Death by euthanasia

Most reported reactions:

  • Loss of appetite (1 reports)
  • Decreased activity (1 reports)
  • Death by euthanasia (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

Quick Facts

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

Species: Both
Manufacturer: Multiple FDA sponsors
Form: Injectable Solution, Liquid (Solution), Oromucosal Gel, Sterile Injectable Solution, Sterile Solution
Identifiers:
ANADA: 200573 ANADA: 200699 ANADA: 200735 ANADA: 200752 ANADA: 200824 NADA: 141267 NADA: 141456 NDC Package: 11695-6967-1 NDC Package: 17033-005-10 NDC Package: 46066-088-13 NDC Package: 54771-1050-1 NDC Package: 54771-2805-1 NDC Package: 54771-2806-1 NDC Package: 64189-8502-0 NDC Package: 64189-8502-1 NDC Package: 68504-006-10 NDC Package: 69043-038-10 NDC Package: 86101-061-41 NDC Package: 86136-105-31 NDC Package: 86136-152-31
Source metadata:

Warnings / Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue. Federal law (USA) 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. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue. Federal law (USA) 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
27
Species represented
2
Grouped by Body System
Digestive (2) · Loss of appetite, Bloody diarrhoea Skin & allergy (1) · Hair loss at application site Neurologic (1) · Unsteady walking (ataxia) Behavior (2) · Biting -aggression, Behavioral disorder (unspecified) Other (26) · Decreased activity, Death by euthanasia, Death
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Digestive 1 Dog 1
Other 1 Cat 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Cat 1
Other 1 Cat 1

Species coverage: Dog (17) Cat (15)

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

1

Official label / PI

1

SPL

7

FOI

9

CIS SILEO N141456G0022-2.pdf

Owner handouts · Labeling

Open original

PI SILEO N141456G0022.pdf

Official label / PI · Labeling

Open original

DEXVETRA™

SPL · SPL

Open original
FDA Structured Product Label

DEXVETRA™

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

Sponsor
Parnell Technologies Pty. Ltd.
ANADA
200-699
Status
RX
Form
Injectable Solution
Route
Intravenous, Intramuscular
Species
Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
0.5 mg/mL

Dogs

Indication

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures.

Dosage

Administer 375 micrograms (mcg) per square meter (/m2) of body surface area by intravenous injection or 500 mcg/m2 of body surface area by intramuscular injection.

Indication

For use as a preanesthetic to general anesthesia.

Dosage

Administer 125 mcg/m2 of body surface area or 375 mcg/m2 of body surface area by intramuscular injection.

Cats

Indication

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures; and as a preanesthetic to general anesthesia.

Dosage

40 mcg/kg by intramuscular injection

Dexmedetomidine Hydrochloride

SPL · SPL

Open original
FDA Structured Product Label

Dexmedetomidine Hydrochloride

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

Sponsor
Felix Pharmaceuticals Pvt. Ltd.
ANADA
200-824
Status
RX
Form
Sterile Injectable Solution
Route
Intravenous, Intramuscular
Composition / specifications
0.5 mg/mL

Dogs

Indication

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures.

Dosage

Administer 375 micrograms (µg) per square meter (/m2) of body surface area by intravenous injection or 500 µg/m2 of body surface area by intramuscular injection.

Indication

For use as a preanesthetic to general anesthesia.

Dosage

Administer 125 µg/m2 of body surface area or 375 µg/m2 of body surface area by intramuscular injection.

Cats

Indication

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures; and as a preanesthetic to general anesthesia.

Dosage

40 µg/killogram by intramuscular injection.

DexmedVet™

SPL · SPL

Open original
FDA Structured Product Label

DexmedVet™

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

Sponsor
Cronus Pharma Specialities India Private Ltd.
ANADA
200-752
Status
RX
Form
Sterile Injectable Solution
Route
Intramuscular, Intravenous
Species
Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
0.5 mg/mL

Dogs

Indication

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. It is also indicated for use as a preanesthetic to general anesthesia.

Dosage

Sedation and Analgesia: 500 mcg/m2 intramuscularly (IM) or 375 mcg/m2 intravenously (IV). Preanesthesia: 125 or 375 mcg/m2 IM.

Cats

Indication

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. It is also indicated for use as a preanesthetic to general anesthesia.


Dosage

Sedation, Analgesia and Preanesthesia: 40 mcg/kg IM.

Dexmedetomidine Hydrochloride

SPL · SPL

Open original
FDA Structured Product Label

Dexmedetomidine Hydrochloride

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

Sponsor
ZYVET AH, Inc.
ANADA
200-735
Status
RX
Form
Injectable Solution
Route
Intravenous, Intramuscular
Species
Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
0.5 mg/mL

Dogs

Indication

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. It is also indicated for use as a preanesthetic to general anesthesia.

Dosage

Sedation and Analgesia: 500 mcg/m2 intramuscularly (IM) or 375 mcg/m2 intravenously (IV). Preanesthesia: 125 or 375 mcg/m2 IM.

Cats

Indication

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. It is also indicated for use as a preanesthetic to general anesthesia.

Dosage

Sedation, Analgesia and Preanesthesia: 40 mcg/kg intramuscularly (IM)

Dexmedesed®

SPL · SPL

Open original
FDA Structured Product Label

Dexmedesed®

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

Sponsor
Dechra Veterinary Products LLC
ANADA
200-573
Status
RX
Form
Sterile Solution
Route
Intramuscular, Intravenous
Species
Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
0.5 mg/mL

<strong>Dogs</strong>

Dosage
For sedative and analgesic administer 375 mcg/m2 by intravenous (IV) injection or 500 mcg/m2 by intramuscular (IM) injection; for preanesthesia administer 125 or 375 mcg/m2 by IM injection

<strong>Cats</strong>

Indication
For use as a sedative and analgesic in dogs and cats to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. Dexmedetomidine HCl is also indicated for use as a preanesthetic to general anesthesia in dogs and cats
Dosage
For sedation, analgesia, or preanesthesia administer 40 mcg/kg IM

SILEO®

SPL · SPL

Open original
FDA Structured Product Label

SILEO®

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

Sponsor
Orion Corp.
NADA
141-456
Status
RX
Form
Oromucosal Gel
Route
Oromucosal
Species
Dog, No Use Class Stated Or Implied
Composition / specifications
Each mL contains 0.09 mg dexmedetomidine (equivalent to 0.1 mg dexmedetomidine hydrochloride)

Dogs

Indication
For the treatment of noise aversion in dogs.
Dosage
Administer onto the oral mucosa between the dog’s cheek and gum at the dose of 125 micrograms per square meter.
Limitations
Federal law (USA) restricts this drug to use by or on the order of a licensed veterinarian.

Dexdomitor®

SPL · SPL

Open original
FDA Structured Product Label

Dexdomitor®

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

Sponsor
Orion Corp.
NADA
141-267
Status
RX
Form
Liquid (Solution)
Route
Intravenous, Intramuscular
Species
Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
Each mL contains 0.5 mg dexmedetomidine hydrochloride

Cats

Indication
For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures.
Dosage
40 mcg/kg by intramuscular (IM) injection.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue.
Indication
For use as a preanesthetic to general anesthesia.
Dosage
40 mcg/kg by intramuscular (IM) injection.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue.

Dogs

Indication
For use as a sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures.
Dosage
Administer 500 mcg/m2 intramuscularly (IM) or 375 mcg/m2 of body surface area by intravenous (IV) injection. Note that the mcg/kg dosage decreases as body weight increases.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue.
Indication
For use as a preanesthetic to general anesthesia.
Dosage
Administer 125 mcg/m2 of body surface area or 375 mcg/m2 of body surface area by intramuscular injection. Note that the mcg/kg dosage decreases as body weight increases.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue.

FOI Summary oA 200-699 Approved March 11, 2021.pdf

FOI · FOI

Open original

FOI Summary oA 200-824 Approved September 19, 2025.pdf

FOI · FOI

Open original

FOI Summary oA 200-752 Approved July 6, 2023.pdf

FOI · FOI

Open original

FOI Summary oA 200-735 Approved January 13, 2023.pdf

FOI · FOI

Open original

UCM436647.pdf

FOI · FOI

Open original

UCM475135.pdf

FOI · FOI

Open original

UCM504535.pdf

FOI · FOI

Open original

ucm062318.pdf

FOI · FOI

Open original

ucm062316.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
  • 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.
  • 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 • No FDA branded products linked
No official FDA brand rows linked yet for this ingredient.
Case-reported brands (openFDA): MSK
Catalog species: Both • FDA-labeled species: Cat, Dog
Rx/OTC: RX
Form/route: Injectable Solution, Liquid (Solution), Oromucosal Gel, Sterile Injectable Solution, Sterile Solution • Intramuscular, Intravenous, Oromucosal
Applications: ANADA 200-699 • ANADA 200-824 • ANADA 200-752 • ANADA 200-735 • ANADA 200-573 • NADA 141-456 • NADA 141-267
Documents: 11 (FOI: 9) • SPL: 7 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 49 • Cat 110 • View
Case summaries: 36 (showing 8) • View
openFDA reports are unverified and do not prove causation.
Explore
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
  • Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue. Federal law (USA) restricts this drug to use by or on the order of a licensed veterinarian. (Contraindication, High)
Top reaction signals
Loss of appetite (1) Decreased activity (1) Death by euthanasia (1) Death (1) Cough, productive (1) Conjunctivitis (1) Cardiac enlargement (1) Cardiac arrest (1)

Identifiers & Packages

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

Identifiers
ANADA: 200573 ANADA: 200699 ANADA: 200735 ANADA: 200752 ANADA: 200824 NADA: 141267 NADA: 141456 NDC Package: 11695-6967-1 NDC Package: 17033-005-10 NDC Package: 46066-088-13 NDC Package: 54771-1050-1 NDC Package: 54771-2805-1 NDC Package: 54771-2806-1 NDC Package: 64189-8502-0 NDC Package: 64189-8502-1 NDC Package: 68504-006-10 NDC Package: 69043-038-10 NDC Package: 86101-061-41 NDC Package: 86136-105-31 NDC Package: 86136-152-31 NDC Product: 11695 NDC Product: 17033 NDC Product: 46066 NDC Product: 54771
Package NDC Product NDC Form / Route Status
11695-6967-1 11695 -
17033-005-10 17033 -
46066-088-13 46066 -
54771-1050-1 54771 -
54771-2805-1 54771 -
54771-2806-1 54771 -
64189-8502-0 64189 -
64189-8502-1 64189 -
68504-006-10 68504 -
69043-038-10 69043 -
86101-061-41 86101 -
86136-105-31 86136 -
86136-152-31 86136 -

Enriched Documents

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

Data Sources & Change Log

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

Official 30 Clinical 9 Manufacturer 0 Marketing 0
Current Field Facts
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respir… (Clinical, 2026-04-15)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respir… (Clinical, 2026-04-15)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respir… (Clinical, 2026-04-11)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-16)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-15)
  • side_effects: Top reported reactions (openFDA): Lack of efficacy - NOS, Vomiting, Injection site swelling, Death, Bradycardia, Diarrhoea. (Clinical, 2026-04-11)
  • usage: For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. For use a… (Clinical, 2026-04-15)
  • usage: For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. For use a… (Clinical, 2026-04-15)
  • usage: For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. For use a… (Clinical, 2026-04-11)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respir… (Official, 2026-04-22)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respir… (Official, 2026-02-12)
  • indications: DEXDOMITOR is indicated for use as a sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, minor surgical procedures, and mi… (Official, 2026-05-05)
  • indications: DEXDOMITOR is indicated for use as a sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, minor surgical procedures, and mi… (Official, 2026-05-03)
  • indications: DEXDOMITOR is indicated for use as a sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, minor surgical procedures, and mi… (Official, 2026-05-02)
  • indications: DEXDOMITOR is indicated for use as a sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, minor surgical procedures, and mi… (Official, 2026-04-29)
  • indications: DEXDOMITOR is indicated for use as a sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, minor surgical procedures, and mi… (Official, 2026-04-28)
  • indications: DEXDOMITOR is indicated for use as a sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, minor surgical procedures, and mi… (Official, 2026-04-27)
  • indications: DEXDOMITOR is indicated for use as a sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, minor surgical procedures, and mi… (Official, 2026-04-26)
  • indications: DEXDOMITOR is indicated for use as a sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, minor surgical procedures, and mi… (Official, 2026-04-25)
  • indications: DEXDOMITOR is indicated for use as a sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, minor surgical procedures, and mi… (Official, 2026-04-22)
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
  • monitoring updated 2026-04-16 13:28 by curated_loader • Clinical monitoring context for feline diabetes management.
  • usage updated 2026-04-16 13:28 by curated_loader • Usage statement from FDA warning letter and approved-product context.
  • drug_profile_type updated 2026-04-16 13:28 by curated_loader • FDA source confirms Senvelgo as a branded approved product.
  • manufacturer_name updated 2026-04-16 13:28 by curated_loader • FDA warning letter identifies the approved sponsor/manufacturer.
  • brand_names updated 2026-04-16 13:28 by curated_loader • FDA warning letter references Senvelgo as the approved animal drug.
  • approval_reference updated 2026-04-16 13:28 by curated_loader • Official FDA application reference for Senvelgo.
  • side_effects updated 2026-04-15 10:07 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-15 10:07 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-15 10:07 by etl_backfill • Backfilled from existing medication fields
  • monitoring updated 2026-04-15 10:07 by curated_loader • Clinical monitoring context for feline diabetes management.
  • usage updated 2026-04-15 10:07 by curated_loader • Usage statement from FDA warning letter and approved-product context.
  • drug_profile_type updated 2026-04-15 10:07 by curated_loader • FDA source confirms Senvelgo as a branded approved product.
  • manufacturer_name updated 2026-04-15 10:07 by curated_loader • FDA warning letter identifies the approved sponsor/manufacturer.
  • brand_names updated 2026-04-15 10:07 by curated_loader • FDA warning letter references Senvelgo as the approved animal drug.
  • approval_reference updated 2026-04-15 10:07 by curated_loader • Official FDA application reference for Senvelgo.
  • side_effects updated 2026-04-15 10:04 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-15 10:04 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
DEXVETRA™
RX
Dexmedetomidine hydrochloride
Injectable Solution • Intravenous, Intramuscular
Label highlights
Official documents
Parnell Technologies Pty. Ltd. ANADA 200-699 Approved Jan 8, 2026
Dexmedetomidine Hydrochloride
RX
Dexmedetomidine hydrochloride
Sterile Injectable Solution • Intravenous, Intramuscular
Label highlights
Official documents
Felix Pharmaceuticals Pvt. Ltd. ANADA 200-824 Approved Oct 1, 2025
DexmedVet™
RX
Dexmedetomidine hydrochloride
Sterile Injectable Solution • Intramuscular, Intravenous
Label highlights
Official documents
Cronus Pharma Specialities India Private Ltd. ANADA 200-752 Approved Aug 1, 2023
Dexmedetomidine Hydrochloride
RX
Dexmedetomidine hydrochloride
Injectable Solution • Intravenous, Intramuscular
Label highlights
Official documents
ZYVET AH, Inc. ANADA 200-735 Approved Feb 1, 2023
Dexmedesed®
RX
Dexmedetomidine hydrochloride
Sterile Solution • Intramuscular, Intravenous
Label highlights
Official documents
Dechra Veterinary Products LLC ANADA 200-573 Approved Dec 16, 2021
SILEO®
RX
Dexmedetomidine
Oromucosal Gel • Oromucosal
Label highlights
Official documents
Orion Corp. NADA 141-456 Approved May 17, 2021
Dexdomitor®
RX
Dexmedetomidine hydrochloride
Liquid (Solution) • Intravenous, Intramuscular
Label highlights
Official documents
Orion Corp. NADA 141-267 Approved Jun 1, 2016

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 • Cat, No Use Class Stated Or Implied
Composition / specifications
0.5 mg/mL
Dogs
Indication

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures.

Dosage

Administer 375 micrograms (mcg) per square meter (/m2) of body surface area by intravenous injection or 500 mcg/m2 of body surface area by intramuscular injection.

Limitations
Indication

For use as a preanesthetic to general anesthesia.

Dosage

Administer 125 mcg/m2 of body surface area or 375 mcg/m2 of body surface area by intramuscular injection.

Limitations
Cats
Indication

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures; and as a preanesthetic to general anesthesia.

Dosage

40 mcg/kg by intramuscular injection

Limitations

FDA page: Open in Animal Drugs @ FDA

Composition / specifications
0.5 mg/mL
Dogs
Indication

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures.

Dosage

Administer 375 micrograms (µg) per square meter (/m2) of body surface area by intravenous injection or 500 µg/m2 of body surface area by intramuscular injection.

Limitations
Indication

For use as a preanesthetic to general anesthesia.

Dosage

Administer 125 µg/m2 of body surface area or 375 µg/m2 of body surface area by intramuscular injection.

Limitations
Cats
Indication

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures; and as a preanesthetic to general anesthesia.

Dosage

40 µg/killogram by intramuscular injection.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
0.5 mg/mL
Dogs
Indication

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. It is also indicated for use as a preanesthetic to general anesthesia.

Dosage

Sedation and Analgesia: 500 mcg/m2 intramuscularly (IM) or 375 mcg/m2 intravenously (IV). Preanesthesia: 125 or 375 mcg/m2 IM.

Limitations
Cats
Indication

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. It is also indicated for use as a preanesthetic to general anesthesia.


Dosage

Sedation, Analgesia and Preanesthesia: 40 mcg/kg IM.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
0.5 mg/mL
Dogs
Indication

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. It is also indicated for use as a preanesthetic to general anesthesia.

Dosage

Sedation and Analgesia: 500 mcg/m2 intramuscularly (IM) or 375 mcg/m2 intravenously (IV). Preanesthesia: 125 or 375 mcg/m2 IM.

Limitations
Cats
Indication

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. It is also indicated for use as a preanesthetic to general anesthesia.

Dosage

Sedation, Analgesia and Preanesthesia: 40 mcg/kg intramuscularly (IM)

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
0.5 mg/mL
<strong>Dogs</strong>
Indication
Dosage
For sedative and analgesic administer 375 mcg/m2 by intravenous (IV) injection or 500 mcg/m2 by intramuscular (IM) injection; for preanesthesia administer 125 or 375 mcg/m2 by IM injection
Limitations
<strong>Cats</strong>
Indication
For use as a sedative and analgesic in dogs and cats to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. Dexmedetomidine HCl is also indicated for use as a preanesthetic to general anesthesia in dogs and cats
Dosage
For sedation, analgesia, or preanesthesia administer 40 mcg/kg IM
Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
Each mL contains 0.09 mg dexmedetomidine (equivalent to 0.1 mg dexmedetomidine hydrochloride)
Dogs
Indication
For the treatment of noise aversion in dogs.
Dosage
Administer onto the oral mucosa between the dog’s cheek and gum at the dose of 125 micrograms per square meter.
Limitations
Federal law (USA) restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
Each mL contains 0.5 mg dexmedetomidine hydrochloride
Cats
Indication
For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures.
Dosage
40 mcg/kg by intramuscular (IM) injection.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue.
Indication
For use as a preanesthetic to general anesthesia.
Dosage
40 mcg/kg by intramuscular (IM) injection.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue.
Dogs
Indication
For use as a sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures.
Dosage
Administer 500 mcg/m2 intramuscularly (IM) or 375 mcg/m2 of body surface area by intravenous (IV) injection. Note that the mcg/kg dosage decreases as body weight increases.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue.
Indication
For use as a preanesthetic to general anesthesia.
Dosage
Administer 125 mcg/m2 of body surface area or 375 mcg/m2 of body surface area by intramuscular injection. Note that the mcg/kg dosage decreases as body weight increases.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue.

FDA page: Open in Animal Drugs @ FDA

Usage

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. For use as a preanesthetic to general anesthesia. For use as a sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue. Federal law (USA) 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
Loss of appetite (1) • Dog Bloody diarrhoea (1) • Cat

Showing top 5 for Digestive.

Skin & allergy
Hair loss at application site (1) • Cat

Showing top 5 for Skin & allergy.

Neurologic
Unsteady walking (1) • Dog

Showing top 5 for Neurologic.

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

Showing top 5 for Behavior.

Other
Decreased activity (1) • Cat Death by euthanasia (1) • Cat Death (1) • Dog Cough, productive (1) • Cat Conjunctivitis (1) • Dog
Show more (21)
Cardiac enlargement (1) • Cat Cardiac arrest (1) • Cat Bruising (1) • Dog Breathing difficulty (1) • Cat Bradycardia (1) • Dog Bladder distension (1) • Cat Bilirubinuria (1) • Cat Basophilia (1) • Cat Bacterial skin infection NOS (1) • Dog Arthritis (1) • Dog Application site pain (1) • Dog Application site discharge NOS (1) • Dog Application site bleeding (1) • Dog Agitation (1) • Cat Acid-base disorder (1) • Dog Abnormal ultrasound finding (1) • Cat Abnormal radiograph finding (1) • Dog Abnormal posture NOS (1) • Dog Abnormal electrocardiogram (1) • Dog Abnormal cytology (1) • Cat Abdominal discomfort (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, Domestic Shorthair, Female, 7 month, 3.08 kilogram • Drug: MSK, Unknown • Reactions: Fever, Cough, productive, Weight loss, Breathing difficulty, Abnormal radiograph finding… • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-075237
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 7.00 Month
  • Weight: 3.080 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Fever Cough, productive Weight loss Breathing difficulty Abnormal radiograph finding Pulmonary disorder NOS Tiredness (lethargy) Sedation Kidney atrophy Bilirubinuria Elevated mean corpuscular haemoglobin concentration Enlarged kidney Elevated mean corpuscular volume Eosinopenia Low serum alkaline phosphatase Neutropenia Discoloured urine Monocytosis Lymphopenia Elevated amylase Elevated alanine aminotransferase Low creatinine Hyponatremia Other abnormal test result NOS Elevated total bilirubin Hyperglycaemia Lymphocytosis Neutrophilia Leucocytosis NOS Basophilia
Outcomes: Recovered/Normal

Dog, Terrier - Bull - Staffordshire, Male, 7.5 year, 28.486 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Injection site oedema • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-074082
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 7.50 Year
  • Weight: 28.486 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Injection site oedema
Outcomes: Recovered/Normal

Dog, Terrier - Bull - American Pit, Male, 7 year, 37 kilogram • Drug: MSK, Injection, Intramuscular, Dose: 0.40 mL per animal • Reactions: Loose stool, Vomiting, Decreased appetite, Decreased drinking, Medication error NOS… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-073901
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 7.00 Year
  • Weight: 37.000 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intramuscular
  • Form: Injection
  • Dose: 0.40 mL per animal
Reactions Reported:
Loose stool Vomiting Decreased appetite Decreased drinking Medication error NOS Lack of efficacy - NOS
Outcomes: Ongoing

Cat, Domestic Shorthair, Female, 6 month, 3.084 kilogram • Drug: MSK, Unknown, Dose: 0.70 Milligram per animal • Reactions: Elevated temperature, Breathing difficulty, Quiet • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074179
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 6.00 Month
  • Weight: 3.084 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Dose: 0.70 Milligram per animal
Reactions Reported:
Elevated temperature Breathing difficulty Quiet
Outcomes: Ongoing

Cat, Maine Coon, Male, 13 year, 6.58 kilogram • Drug: MSK, Unknown • Reactions: Twitching, Focal seizure, Death, Tiredness (lethargy) • Outcome: Died

  • Report ID: USA-USFDACVM-2025-US-074994
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Male
  • Age: 13.00 Year
  • Weight: 6.580 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Twitching Focal seizure Death Tiredness (lethargy)
Outcomes: Died

Dog, Bulldog - French, Female, 11 year, 12.066 kilogram • Drug: MSK, Injection, Intravenous, Dose: 0.12 mL per dose, Frequency: 1 per day • Reactions: Lack of efficacy, Swollen limb, Wound, Local erythema, Bruising • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-074617
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 11.00 Year
  • Weight: 12.066 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intravenous
  • Form: Injection
  • Dose: 0.12 mL per dose
  • Frequency: 1 per day
Reactions Reported:
Lack of efficacy Swollen limb Wound Local erythema Bruising
Outcomes: Outcome Unknown

Cat, Domestic Shorthair, Female, 4 month, 2.5 kilogram • Drug: MSK, Injection, solution, Intramuscular, Dose: 0.05 mL per animal • Reactions: Drooling, Tachypnoea, Abnormal radiograph finding, Hypothermia, Hyperactivity… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074533
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 4.00 Month
  • Weight: 2.500 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intramuscular
  • Form: Injection, solution
  • Dose: 0.05 mL per animal
Reactions Reported:
Drooling Tachypnoea Abnormal radiograph finding Hypothermia Hyperactivity Not eating Tiredness (lethargy) Hiding
Outcomes: Ongoing

Dog, Pug, Female, 6 year, 9.344 kilogram • Drug: MSK, Injection, Intramuscular, Dose: 0.05 mL per dose, Frequency: 1 per day • Reactions: Swollen limb, Limb non-weight bearing, Pain NOS, Bruising, Local erythema… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-073872
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 6.00 Year
  • Weight: 9.344 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intramuscular
  • Form: Injection
  • Dose: 0.05 mL per dose
  • Frequency: 1 per day
Reactions Reported:
Swollen limb Limb non-weight bearing Pain NOS Bruising Local erythema Injection site skin discolouration
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.

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