NDC | 11695-4851-1 |
Set ID | 53f5e51e-94c1-4f0e-b4d3-30f423b1c6db |
Category | PRESCRIPTION ANIMAL DRUG LABEL |
Packager | Butler Animal Health Supply LLC dba Henry Schein Animal Health |
Generic Name | |
Product Class | |
Product Number | |
Application Number | ANADA200266 |
- SPL UNCLASSIFIED SECTION
-
DESCRIPTION
DESCRIPTION: Phenylbutazone Paste is a synthetic, non-hormonal anti-inflammatory, antipyretic compound useful in the management of inflammatory conditions. The apparent analgesic effect is probably related mainly to the compound's anti-inflammatory properties. Chemically, Phenylbutazone Paste is 4-butyl-1, 2-diphenyl-3, 5-pyrazolidinedione. It is a pyrazolone derivative, entirely unrelated to the steroid hormones.
- VETERINARY INDICATIONS
- CONTRAINDICATIONS
- FOOD SAFETY WARNING
-
PRECAUTIONS
PRECAUTIONS: Stop medication at the first sign of gastrointestinal upset, jaundice, or blood dyscrasia. Authenticated cases of agranulocytosis associated with the drug have occurred in man; fatal reactions, although rare, have been reported in dogs after long-term therapy. To guard against this possibility, conduct routine blood counts at weekly intervals during the early phase of therapy and at intervals of two weeks thereafter. Any significant fall in the total white blood cell count, relative decrease in granulocytes, or black or tarry stools should be regarded as a signal for immediate cessation of therapy and institution of appropriate counter-measures. In the treatment of inflammatory conditions associated with infections, specific anti-infective therapy is required.
-
DOSAGE & ADMINISTRATION
ADMINISTRATION AND DOSAGE: Orally - 1 to 2 g of phenylbutazone per 500 lb. of body weight daily. Do not exceed 4 g daily.
Guidelines to Successful Therapy: Use a relatively high dose for the first 48 hours, then reduce gradually to a maintenance dose. Maintain the lowest dose capable of producing desired clinical response. Response to Phenylbutazone Paste therapy is prompt, usually occurring within 24 hours. If no significant clinical effect is evident after five days, re-evaluate diagnosis and therapeutic approach.
When administering Phenylbutazone Paste, the oral cavity should be empty. Deposit paste on back of tongue by depressing plunger that has been previously set to deliver the correct dose. Many chronic conditions will respond to Phenylbutazone Paste therapy, but discontinuance of treatment may result in recurrence of symptoms.
- STORAGE AND HANDLING
- HOW SUPPLIED
- SAFE HANDLING WARNING
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - 60 mL Syringe Label
HENRY SCHEIN®
ANIMAL HEALTHNDC #11695-4851-1
ANADA #200-266, Approved by FDA
BUTAPASTE™
Phenylbutazone Paste for HorsesFOR VETERINARY USE ONLY
APPLE FLAVOR
Each syringe contains 20 g phenylbutazone.
Each 3 mL marking on the plunger contains Phenylbutazone: 1 g.
Indications: For the relief of inflammatory conditions associated
with the musculoskeletal system in horses.Dosage: 1 to 2 g of phenylbutazone per 500 lb body weight, but not
to exceed 4 g daily. Oral cavity should be empty. Deposit paste on
the back of tongue by depressing plunger that has been previously
set to deliver the correct dose.WARNING: Not for use in horses intended for food.
CAUTION: Federal (U.S.A.) law restricts this drug to use by or on
the order of a licensed veterinarian.KEEP OUT OF REACH OF CHILDREN
See package insert for additional information.
Store at 15°-30°C (59°-86°F).
Net Volume: 60 mL
Reorder #044015
Distributed Exclusively by
Henry Schein Animal Health
Dublin, OH 43017www.henryscheinvet.com
HENRY SCHEIN
SEAL OF EXCELLENCEVetUS™
Lot #/Exp. Date:
Rev. 06/13
-
INGREDIENTS AND APPEARANCE
BUTAPASTE
phenylbutazone pasteProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:11695-4851 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Phenylbutazone (UNII: GN5P7K3T8S) (Phenylbutazone - UNII:GN5P7K3T8S) Phenylbutazone 35.1 g in 100 g Product Characteristics Color Score Shape Size Flavor APPLE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11695-4851-1 60 g in 1 SYRINGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200266 08/14/2012 Labeler - Butler Animal Health Supply LLC dba Henry Schein Animal Health (017880659) Registrant - Vetoquinol USA, Inc. (106824209) Establishment Name Address ID/FEI Business Operations Med-Pharmex, Inc. 025353699 MANUFACTURE Establishment Name Address ID/FEI Business Operations Sintenovo SA DE CV 812039808 API MANUFACTURE