This page reprints a manufacturer label. Everything below in quotation marks is copied from Pancreatic Enzyme Concentrate, 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 Pancreatic Enzyme Concentrate by Covetrus North America, a pancrelipase lipase, pancrelipase protease and pancrelipase amylase 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. 2 other stored labels carry the same active ingredient and are listed at the end.
The label
Product: Pancreatic Enzyme Concentrate. Manufacturer: Covetrus North America. FDA Structured Product Label set id 66e450e3-86aa-4aa4-af1e-af134822e135. Label effective 2026-05-14. Retrieved 2026-09-16 from the DailyMed animal label release, and readable on DailyMed.
Indications
For use as a digestive aid in replacement therapy where digestion of protein, carbohydrate, and fat is inadequate due to exocrine pancreatic insufficiency in dogs and cats. Each 2.8 g (1 teaspoon) contains a minimum of: Lipase 71,400 USP units Protease 388,000 USP units Amylase 460,000 USP units
Dosage and Administration
Pancreatic Enzyme Concentrate should be administered with a small amount of food before each meal. Consult with your veterinarian for the appropriate dose based on the severity of the condition and weight of the animal. Add the recommended dose to moistened food (canned or dry) and mix thoroughly to bring the enzymes in contact with the food particles. Let the mixture sit at room temperature for 20 minutes before feeding. Follow with the remainder of the meal. Average dose/meal: Dogs : 3/4 - 1 teaspoon (2.8g/teaspoon) Cats : 1/4 - 3/4 teaspoon.
Precautions
Discontinue use in animals with symptoms of sensitivity or allergy. May cause temporary oral mucosal irritation that is treatable by reducing dose or diluting dose with a small amount of water. Consult with your veterinarian regarding dosing. Store in tightly closed container in a dry place at temperatures between 59° and 86°F (15° - 30°C). Pancreatic Enzyme Concentrate Powder - 4 ounce Pancreatic Enzyme Concentrate Powder - 8 ounce Pancreatic Enzyme Concentrate Powder - 12 ounce image description image description image description
Description
This product is a pancreatic enzyme concentrate of porcine origin.
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.
- Pancreatic Enzyme Concentrate, Covetrus North America. Set id 59ddb2e4-058e-4b11-a0ef-3cb1845d3051.
- PancreVed Pancreatic Enzyme PANCRELIPASE LIPASE PANCRELIPASE LIPASE PANCRELIPASE AMYLASE PANCRELIPASE AMYLASE PANCRELIPASE PROTEASE PANCRELIPASE PROTEASE, Vedco, INC. Set id 65188b43-b702-4fbc-9ea1-3832532daf02.
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 pancrelipase lipase and pancrelipase protease and pancrelipase amylase 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: 13 reports
| VeDDRA reaction term | Reports |
|---|---|
| Anorexia | 3 |
| Lethargy (see also Central nervous system depression in 'Neurological') | 3 |
| Vomiting | 3 |
| Diarrhoea | 2 |
| Itching | 2 |
| Loose stool | 2 |
| Odor, Abnormal | 2 |
| Partial adipsia | 2 |
| Abnormal ultrasound finding | 1 |
| Adipsia | 1 |
| Alopecia | 1 |
| Appearance, Abnormal | 1 |
| Behavioural disorder NOS | 1 |
| Blood in faeces | 1 |
| Bloody diarrhoea | 1 |
Outcome as recorded by the reporter: Outcome Unknown 6; Recovered/Normal 4; Recovered with Sequela 2; Died 1.
Queries: reports, reactions, outcomes. Dataset: openFDA Animal and Veterinary Adverse Event Reports.
Cats: 1 reports
| VeDDRA reaction term | Reports |
|---|---|
| Death by euthanasia | 1 |
| Intestinal disorder NOS | 1 |
| Pain NOS | 1 |
| Rectal prolapse | 1 |
| Retching | 1 |
| Vocalisation | 1 |
Outcome as recorded by the reporter: Euthanized 1.
Queries: reports, reactions, outcomes. Dataset: openFDA Animal and Veterinary Adverse Event Reports.
Sources
- Pancreatic Enzyme ConcentrateFDA · retrieved 2026-09-16
“Pancreatic Enzyme Concentrate should be administered with a small amount of food before each meal.” (Dosage and Administration)
- openFDA Animal and Veterinary Adverse Event ReportsFDA · retrieved 2026-09-16
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From Glarda
The note drafted from the consult, with the reference you just read sitting beside it in the shape your record already expects.