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Roxee Medication Guide
Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.
Veterinary professional?
These are the reference facts Roxee uses on browse cards and quick facts.
Sponsor, product, and application records imported from Animal Drugs @ FDA.
openFDA reaction terms and case summaries are supporting evidence, not proof of causality.
Drug type: Generic ingredient • Generic profile • No FDA branded products linked
Species: Both
Manufacturer: Multiple FDA sponsors
Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.
PromAce Injectable can be used as an aid in controlling intractable animals during examination, treatment, grooming, x-ray and minor surgical procedures; to alleviate itching as a result of skin irritation; as an antiemetic to control vomiting associated with motion sickness. PromAce Injectable can be used as an aid in controlling fractious animals during examination,treatment, loading and transportation. Particularly useful when used in conjunction with local anesthesia for firing, castration, neurectomy, removal of skin tumors, ocular surgery and applying casts. Used as an aid in controlling intractable animals during examination, treatment, grooming, x-ray, and minor surgical procedures; to alleviate itching as a result of skin irritation; as an antlemetic to control comiting associated with motion sickness. Species commonly shown: Both, Dog, Horse.
PromAce Injectable can be used as an aid in controlling intractable animals during examination, treatment, grooming, x-ray and minor surgical procedures; to alleviate itching as a result of skin irritation; as an antiemetic to control vomiting associated with motion sickness. PromAce Injectable can be used as an aid in controlling fractious animals during examination,treatment, loading and transportation. Particularly useful when used in conjunction with local anesthesia for firing, castration, neurectomy, removal of skin tumors, ocular surgery and applying casts. Used as an aid in controlling intractable animals during examination, treatment, grooming, x-ray, and minor surgical procedures; to alleviate itching as a result of skin irritation; as an antlemetic to control comiting associated with motion sickness.
Not for use in animals intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Top reported reactions (openFDA): Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Death, Death by euthanasia, Diarrhoea, Lack of efficacy - NOS.
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Used for:
As an aid in tranquilization and as a preanesthetic agent in dogs. Acepromazine Maleate Tablets can be used as an aid in controlling intractable animals during examination, treatment, grooming, x-ray and minor surgical p...
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:
When to call the vet:
Regulatory restrictions are shown in Vet View.
What to tell or ask your vet today:
A source-aware map of what to know, what is uncertain, and what to verify with your veterinarian.
Roxee has limited cited overview evidence for Acepromazine Maleate; use the official documents and your veterinarian's instructions for product-specific decisions.
32 tracked reaction signals; 32 reported cases; 29 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.
Adverse-event reports help form a watch list, but they do not prove the medication caused the reaction and they are not a risk ranking between medications.
Official labels, package inserts, and reviewed summaries carry more weight than isolated reports.
Case reports and openFDA terms are useful for pattern awareness, but they are incomplete, can include multiple exposures, and do not estimate an individual pet's probability of harm.
Loss of appetite (1 reports), Lateral recumbency (1 reports), Lack of efficacy - NOS (1 reports), Laboured breathing (1 reports), Injection site lump (1 reports)
Digestive (2), Neurologic (1), Behavior (1), Effectiveness (1)
Dog (16 reports), Cat (16 reports)
Greyhound (1), ['Retriever - Golden', 'Poodle - Standard'] (1), Crossbred Canine/dog (1), Bulldog - French (1). These are report metadata, not proof that a breed is at higher risk.
Verify whether Acepromazine Maleate fits the pet's species, current diagnosis, age, weight, organ status, pregnancy/lactation status, and concurrent medications.
Separate label-backed warnings from adverse-event reports and owner observations before changing the plan.
Loss of appetite, Lateral recumbency, Lack of efficacy - NOS
Repeated vomiting or diarrhea. Severe lethargy (hard to wake, very low energy). Collapse or fainting.
Review status / Updated / Sources
Review status: Clinical reviewer not listed
Updated: April 15, 2026, 10:04 AM UTC
Side effects to monitor:
Most reported reactions:
Emergency warning signs:
Source-backed clinical checkpoints for quick review.
Official label facts first, then secondary summaries. Marketing content is separated below.
Not for use in animals intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.
Filter stored openFDA reports by pet and report attributes. Counts describe reports in this data set, not risk.
Received 2025-12-29 · MSK · MSK
Received 2025-12-29 · MSK · MSK
Received 2025-12-29 · MSK · MSK
Received 2025-10-22 · MSK · MSK
Tap or hover a reaction to see what it means in plain language.
| Reaction | Body system | Cases | Species | Serious cases |
|---|---|---|---|---|
| Digestive | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Effectiveness | 1 | Dog | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Dog | 1 |
Species coverage: Dog (16) Cat (16)
| Reaction | Body system | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|---|
| Digestive | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Effectiveness | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Neurologic | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Digestive | Cat | Non-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 | |
| Behavior | 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 | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 |
The most useful source links appear first; full previews and metadata stay in the veterinary/professional layer.
Use original documents to confirm product-specific warnings, ingredients, and handling details with your veterinarian.
Full source previews and metadata remain in the veterinary/professional layer.
SPL · SPL
Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.
As an aid in tranquilization and as a preanesthetic agent in dogs. Acepromazine Maleate Tablets can be used as an aid in controlling intractable animals during examination, treatment, grooming, x-ray and minor surgical procedures.
0.25 – 1.0 mg/lb of body weight. Dosage may be repeated as required.
SPL · SPL
Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.
SPL · SPL
Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.
FOI · FOI
FOI · FOI
FOI · FOI
Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.
Quick facts and links to official labeling and safety signals.
Diagnosis-code mappings are not available for this medication yet.
Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.
Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.
| Package NDC | Product NDC | Form / Route | Status |
|---|---|---|---|
| 0010-3827-01 | 0010 | - | |
| 0010-6703-01 | 0010 | - | |
| 0010-6703-02 | 0010 | - | |
| 0010-6704-01 | 0010 | - | |
| 0010-6704-02 | 0010 | - | |
| 10695-181-10 | 10695 | - | |
| 11695-0093-1 | 11695 | - | |
| 11695-0093-5 | 11695 | - | |
| 11695-0094-1 | 11695 | - | |
| 11695-0094-5 | 11695 | - | |
| 11695-0095-5 | 11695 | - | |
| 11695-7033-1 | 11695 | - | |
| 11695-7033-2 | 11695 | - | |
| 11695-7034-1 | 11695 | - | |
| 11695-7034-2 | 11695 | - | |
| 13985-582-25 | 13985 | - | |
| 13985-582-50 | 13985 | - | |
| 13985-583-10 | 13985 | - | |
| 13985-583-50 | 13985 | - | |
| 13985-587-50 | 13985 | - |
Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.
Every non-trivial field is expected to include provenance and update timestamps.
Official sponsor/proprietary-name/application-status records linked by active ingredient.
| Product | Sponsor | Application | Status | Published |
|---|---|---|---|---|
|
Acepromazine Maleate Tablets
RX
Acepromazine Maleate
Tablet
• Oral
|
ZYVET AH, Inc. | ANADA 200-757 | Approved | Sep 1, 2023 |
|
Acepromazine Maleate Injection
RX
Acepromazine Maleate
Liquid (Solution)
• Intramuscular, Intravenous, Subcutaneous
|
Boehringer Ingelheim Animal Health USA Inc. | ANADA 200-361 | W | May 3, 2023 |
|
Acepromazine Maleate Injection
RX
Acepromazine Maleate
Liquid (Solution)
• Subcutaneous, Intravenous, Intramuscular
|
Elanco US Inc. | ANADA 200-319 | Approved | Jun 1, 2016 |
Data source: FDA Animal Drugs @ FDA (public search export).
Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.
As an aid in tranquilization and as a preanesthetic agent in dogs. Acepromazine Maleate Tablets can be used as an aid in controlling intractable animals during examination, treatment, grooming, x-ray and minor surgical procedures.
0.25 – 1.0 mg/lb of body weight. Dosage may be repeated as required.
FDA page: Open in Animal Drugs @ FDA
FDA page: Open in Animal Drugs @ FDA
FDA page: Open in Animal Drugs @ FDA
PromAce Injectable can be used as an aid in controlling intractable animals during examination, treatment, grooming, x-ray and minor surgical procedures; to alleviate itching as a result of skin irritation; as an antiemetic to control vomiting associated with motion sickness. PromAce Injectable can be used as an aid in controlling fractious animals during examination,treatment, loading and transportation. Particularly useful when used in conjunction with local anesthesia for firing, castration, neurectomy, removal of skin tumors, ocular surgery and applying casts. Used as an aid in controlling intractable animals during examination, treatment, grooming, x-ray, and minor surgical procedures; to alleviate itching as a result of skin irritation; as an antlemetic to control comiting associated with motion sickness.
Source: FDA Animal Drugs @ FDA • Reference
Not for use in animals intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).
Showing top 5 for Digestive.
Showing top 5 for Neurologic.
Showing top 5 for Behavior.
Showing top 5 for Effectiveness.
Showing top 5 for Other.
Data source: FDA openFDA Animal & Veterinary adverse event reports.
These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.
Dog, Greyhound, Female, 9 year, 27.3 kilogram • Drug: MSK, Subcutaneous • Reactions: Lack of efficacy - NOS, Unrelated death • Outcome: Euthanized
Dog, ['Retriever - Golden', 'Poodle - Standard'], Male, 5 year, 25.5 kilogram • Drug: MSK, Subcutaneous • Reactions: Lack of efficacy - NOS, Unrelated death • Outcome: Euthanized
Dog, Crossbred Canine/dog, Male, 14 year, 17.7 kilogram • Drug: MSK, Subcutaneous • Reactions: Lack of efficacy - NOS, Unrelated death • Outcome: Euthanized
Dog, Bulldog - French, Female, 8 year, 12.927 kilogram • Drug: MSK, Injection, solution, Intramuscular, Dose: 0.03 mL per animal • Reactions: Tachycardia, Apnoea, Cyanosis, Cardiac arrest, Death… • Outcome: Died
Cat, Domestic Shorthair, Male, 2 year, 4.536 kilogram • Drug: MSK, Injection, solution, Unknown • Reactions: Seizure NOS, Death by euthanasia • Outcome: Euthanized
Dog, Spitz - German Pomeranian, Male, 10 year, 3.221 kilogram • Drug: MSK, Unknown • Reactions: Vomiting • Outcome: Recovered/Normal
Cat, Domestic Mediumhair, Female, 6.08 year, 4.82 kilogram • Drug: MSK, Intramuscular, Dose: 1 Milligram per ml • Reactions: Fibrosarcoma, Decreased activity, Hissing, Injection site lump, Behavioral disorder (unspecified)… • Outcome: Outcome Unknown
Cat, Cat (unknown), Mixed, 4 month, 1.09 kilogram • Drug: MSK, Intramuscular, Dose: 0.05 Milligram per kilogram • Reactions: Increased heart rate, Increased respiratory rate, Lack of efficacy - NOS • Outcome: Recovered/Normal
Data source: FDA openFDA Animal & Veterinary adverse event reports.
No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.
No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.
Let others know your experience or advice regarding this medication.
This medication has not been reviewed by a veterinarian yet.