This page reprints a manufacturer label. Everything below in quotation marks is copied from Acepromazine maleate Injection, published by FDA and retrieved on 2026-09-16. Nothing has been added, reworded or left out of the sections shown. It is the manufacturer’s label, reproduced as published.
This page reprints the FDA label for Acepromazine maleate Injection by Covetrus North America, a acepromazine product labelled for dogs and cats. The sections below are copied from that label without change, with the set id and the date it was retrieved from DailyMed. 10 other stored labels carry the same active ingredient and are listed at the end.
The label
Product: Acepromazine maleate Injection. Manufacturer: Covetrus North America. FDA Structured Product Label set id 5a45a554-fcd7-44d4-a6b3-7dbcb63b25a9. Label effective 2025-04-23. Retrieved 2026-09-16 from the DailyMed animal label release, and readable on DailyMed.
Indications
Dogs and cats: Acepromazine maleate injection 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. Acepromazine maleate injection is particularly useful as a preanesthetic agent (1) to enhance and prolong the effects of barbiturates, thus reducing the requirements for general anesthesia; (2) as an adjunct to surgery under local anesthesia. Horses: Acepromazine maleate injection 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.
Dosage and Administration
The dosage should be individualized, depending upon the degree of tranquilization required. As a general rule, the dosage requirement in mg/lb of body weight decreases as the weight of the animal increases. Acepromazine maleate injection may be given intravenously, intramuscularly or subcutaneously. The following schedule may be used as a guide to IV, IM or SC injections. Dogs: 0.25–0.5 mg/lb of body weight Cats: 0.5–1 mg/lb of body weight Horses: 2–4 mg/100 lb of body weight IV doses should be administered slowly, and a period of at least 15 minutes should be allowed for the drug to take full effect.
Contraindications
Phenothiazines may potentiate the toxicity of organophosphates and the activity of procaine hydrochloride. Therefore, do not use Acepromazine maleate injection to control tremors associated with organic phosphate poisoning. Do not use in conjunction with organophosphorus vermifuges or ectoparasiticides, including flea collars. Do not use with procaine hydrochloride.
Warnings
Do not use in horses intended for human consumption.
Precautions
Tranquilizers are potent central nervous system depressants and they can cause marked sedation with suppression of the sympathetic nervous system. Tranquilizers can produce prolonged depression or motor restlessness when given in excessive amounts or when given to sensitive animals. Tranquilizers are additive in action to the actions of other depressants and will potentiate general anesthesia. Tranquilizers should be administered in smaller doses and with greater care during general anesthesia and also to animals exhibiting symptoms of stress, debilitation, cardiac disease, sympathetic blockade, hypovolemia or shock. Acepromazine maleate injection, like other phenothiazine derivatives, is detoxified in the liver; therefore, it should be used with caution in animals with a previous history of liver dysfunction or leukopenia. Hypotension can occur after rapid intravenous injection causing cardiovascular collapse. Epinephrine is contraindicated for treatment of acute hypotension produced by phenothiazine-derivative tranquilizers since further depression of blood pressure can occur. Other pressor amines, such as norepinephrine or phenylephrine, are the drugs of choice. In horses, paralysis of the retractor penis muscle has been associated with the use of phenothiazine-derivative tranquilizers. Such cases have occurred following the use of Acepromazine maleate injection. This risk should be duly considered prior to the administration of Acepromazine maleate injection to male horses (castrated and uncastrated). When given, the dosage should be carefully limited to the minimum necessary for the desired effect. At the time of tranquilization, it is not possible to differentiate between reversible protrusion of the penis (a normal clinical sign of narcosis) and the irreversible paralysis of the retractor muscle. The cause of this side reaction has not been determined. It has been postulated that such paralysis may occur when a tranquilizer is used in conjunction with testosterone (or in stallions). Accidental intracarotid injection in horses can produce clinical signs ranging from disorientation to convulsive seizures and death.
Adverse Reactions
A few rare but serious occurrences of idiosyncratic reactions to acepromazine may occur in dogs following oral or parenteral administration. These potentially serious adverse reactions include behavioral disorders in dogs such as aggression, biting/chewing, and nervousness. To report suspected adverse reactions, to obtain a Safety Data Sheet or for technical assistance, call 1-855-724-3461. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS, or www.fda.gov/reportanimalae.
Description
Acepromazine maleate injection, a potent neuroleptic agent with a low order of toxicity, is of particular value in the tranquilization of dogs, cats and horses. Its rapid action and lack of hypnotic effect are added advantages. According to Baker, 1 the scope of possible applications for this compound in veterinary practice is only limited by the imagination of the practitioner. Each mL contains: Acepromazine maleate 10 mg, sodium citrate 0.36%, citric acid 0.075%, benzyl alcohol 1% and water for injection. Acepromazine [10-[3-(dimethylamino) propyl] phenothiazin-2-yl-methyl ketone] Maleate, USP has the following chemical structure: Acepromazine maleate injection has a depressant effect on the central nervous system and, therefore, causes sedation, muscular relaxation and a reduction in spontaneous activity. It acts rapidly, exerting a prompt and pronounced calming effect. Picture of chemical structure of Acepromazine Maleate, USP.
Storage
Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C (between 59° and 86°F). When used as labeled, there is no limit on the number of punctures throughout the full expiry period.
Other labels for this ingredient
These labels are also stored for the same active ingredient. They are not identical to the one reprinted above, and each is listed by product and set id rather than merged with it.
- Acepromazine Injection (acepromazine maleate injection), MWI/VetOne. Set id e1039978-b318-4611-9fdc-fe7ab10e3246.
- PromAce ® Injectable (acepromazine maleate injection), Boehringer Ingelheim Animal Health USA Inc.. Set id 11ee8981-46eb-4791-8e40-727c991341fe.
- Acepromazine Maleate Tablets 25 mg, MWI/VetOne. Set id 6c3301b6-7bfe-41ce-91b6-c1e7f14bf2e4.
- Acepromazine Maleate Tablets, Covetrus North America. Set id 7fffe11f-4628-47ce-b462-2e256f38eae2.
- Acepromazine Maleate Tablets, Covetrus North America. Set id 856decdd-65cd-4232-b198-e89f96aaffbf.
- PromAce® Tablets (acepromazine maleate tablets), Boehringer Ingelheim Animal Health USA Inc.. Set id 89338c4d-f2de-4991-87f2-dcea4535e2e2.
- PromAce® Tablets (acepromazine maleate tablets), Boehringer Ingelheim Animal Health USA Inc.. Set id ecf0cdff-adb3-4427-99a8-158939fc1c94.
- Acepromazine Maleate Tablets 10 mg, MWI/VetOne. Set id f130b697-ab4d-4c30-82e0-56904fdc1b0c.
- Aspen Veterinary Resources®, LTD. ZYVET ANIMAL HEALTH INC. ACEPROMAZINE MALEATE acepromazine maleate ACEPROMAZINE MALEATE ACEPROMAZINE Light pink to peach 35;U ACEPROMAZINE MALEATE acepromazine maleate ACEPROMAZINE MALEATE ACEPROMAZINE 37;U Acepromazine Maleate Tablets, Aspen Veterinary Resources®, LTD.. Set id 65892949-2959-42c3-a79f-80d8977086b0.
- Covetrus North America ZYVET ANIMAL HEALTH INC. ACEPROMAZINE MALEATE acepromazine maleate ACEPROMAZINE MALEATE ACEPROMAZINE Light pink to peach 35;U ACEPROMAZINE MALEATE acepromazine maleate ACEPROMAZINE MALEATE ACEPROMAZINE 37;U Acepromazine Maleate Tablets, Covetrus North America. Set id 934fcdff-5ae4-48f5-baa0-ddf549662a56.
FDA adverse event reports
The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming acepromazine as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.
These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.
Dogs: 1,789 reports
| VeDDRA reaction term | Reports |
|---|---|
| Vomiting | 281 |
| Lethargy (see also Central nervous system depression in 'Neurological') | 186 |
| Death | 178 |
| Diarrhoea | 127 |
| Anorexia | 126 |
| Lack of efficacy - NOS | 122 |
| Death by euthanasia | 119 |
| Elevated alanine aminotransferase (ALT) | 96 |
| Bradycardia | 95 |
| Other abnormal test result NOS | 95 |
| Seizure NOS | 92 |
| Emesis | 84 |
| Vocalisation | 83 |
| Ataxia | 72 |
| Tachycardia | 69 |
Outcome as recorded by the reporter: Recovered/Normal 624; Ongoing 385; Outcome Unknown 256; Died 199; Euthanized 136; Recovered with Sequela 21.
Queries: reports, reactions, outcomes. Dataset: openFDA Animal and Veterinary Adverse Event Reports.
Cats: 617 reports
| VeDDRA reaction term | Reports |
|---|---|
| Death | 121 |
| Behavioural disorder NOS | 60 |
| Cardiac arrest | 42 |
| Anorexia | 39 |
| Ataxia | 38 |
| Fever | 34 |
| Vomiting | 34 |
| Death by euthanasia | 33 |
| Lethargy (see also Central nervous system depression in 'Neurological') | 32 |
| Dilated pupils | 31 |
| Recovery prolonged | 31 |
| Apnoea | 30 |
| Elevated temperature | 29 |
| Hyperthermia | 29 |
| Lack of efficacy - NOS | 28 |
Outcome as recorded by the reporter: Recovered/Normal 189; Died 131; Ongoing 110; Outcome Unknown 81; Euthanized 37; Recovered with Sequela 3.
Queries: reports, reactions, outcomes. Dataset: openFDA Animal and Veterinary Adverse Event Reports.
Sources
- Acepromazine maleate InjectionFDA · retrieved 2026-09-16
“The dosage should be individualized, depending upon the degree of tranquilization required.” (Dosage and Administration)
- openFDA Animal and Veterinary Adverse Event ReportsFDA · retrieved 2026-09-16
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