Label: PANACUR- fenbendazole suspension
- NDC Code(s): 57926-086-01
- Packager: Merck Sharp & Dohme Corp.
- Category: PRESCRIPTION ANIMAL DRUG LABEL
Updated September 10, 2021
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INDICATIONS: Beef and Dairy Cattle - 2.3 mg/lb (5 mg/kg) body weight for the treatment and control of: Lungworms: Adult Dictyocaulus viviparus; Stomach worms: Adult brown stomach worms (Ostertagia ostertagi), Adult and fourth stage larvae barberpole worms (Haemonchus contortus & H. placei), and Adult and fourth stage larvae small stomach worms (Trichostrongylus axei); Intestinal worms (Adult and fourth stage larvae): hookworms (Bunostomum phlebotomum), thread-necked intestinal worms (Nematodirus helvetianus), small intestinal worms (Cooperia punctata & C. oncophora), bankrupt worms (Trichostrongylus colubriformis), and nodular worms (Oesophagostomum radiatum).
DOSAGE & ADMINISTRATION
DIRECTIONS: Administer orally. In beef and dairy cattle, the recommended dose of 2.3 mg/lb (5 mg/ kg) is achieved when 2.3 mL of the drug are given for each 100 lb of body weight. In beef cattle only, the recommended dose of 4.6 mg/lb (10 mg/kg) for treatment and control of Type II Ostertagiasis (4th stage inhibited larvae) or tapeworms is achieved when 4.6 mL of the drug is given for each 100 lb of body weight.
Cattle Weight Dose
100 lb 2.3 mL 4.6 mL 200 lb 4.6 mL 9.2 mL 300 lb 6.9 mL 13.8 mL 400 lb 9.2 mL 18.4 mL 500 lb 11.5 mL 23.0 mL 1000 lb 23.0 mL 46.0 mL 1500 lb 34.5 mL 69.0 mL
Do not underdose. Ensure each animal receives a complete dose based on a current body weight. Underdosing may result in ineffective treatment, and encourage the development of parasite resistance.
WARNINGS: NOT FOR USE IN HUMANS. KEEP OUT OF REACH OF CHILDREN. The Safety Data Sheet (SDS) contains more detailed occupational safety information. For customer service, adverse effects reporting, and/or a copy of the SDS, call 1-800-211-3573. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDAVETS, or http://www.fda.gov/reportanimalae.
OTHER WARNINGS: Parasite resistance may develop to any dewormer, and has been reported for most classes of dewormers. Treatment with a dewormer used in conjunction with parasite management practices appropriate to the geographic area and the animal(s) to be treated may slow the development of parasite resistance. Fecal examinations or other diagnostic tests and parasite management history should be used to determine if the product is appropriate for the herd, prior to the use of any dewormer. Following the use of any dewormer, effectiveness of treatment should be monitored (for example, with the use of a fecal egg count reduction test or another appropriate method). A decrease in a drug's effectiveness over time as calculated by fecal egg count reduction tests may indicate the development of resistance to the dewormer administered. Your parasite management plan should be adjusted accordingly based on regular monitoring.
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 3,785 mL Bottle Label
for Beef & Dairy Cattle
Withdrawal Periods and Residue Warnings: Milk
taken from cows during treatment and for 48 hours
after the last treatment must not be used for human
consumption. Cattle must not be slaughtered for
human consumption within 8 days following last
treatment with this drug product. Not for use in beef
calves less than 2 months of age, dairy calves, and veal
calves. A withdrawal period has not been established
for this product in pre-ruminating calves.
CAUTION: Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
1 Gallon (3,785 mL)
INGREDIENTS AND APPEARANCE
Product Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:57926-086 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Fenbendazole (UNII: 621BVT9M36) (Fenbendazole - UNII:621BVT9M36) Fenbendazole 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength methylparaben (UNII: A2I8C7HI9T) propylparaben (UNII: Z8IX2SC1OH) silicon dioxide (UNII: ETJ7Z6XBU4) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) trisodium citrate dihydrate (UNII: B22547B95K) citric acid monohydrate (UNII: 2968PHW8QP) water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57926-086-01 3785 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA128620 09/16/2009 Labeler - Merck Sharp & Dohme Corp. (001317601) Establishment Name Address ID/FEI Business Operations Intervet Production S.A. 771867553 ANALYSIS, MANUFACTURE Establishment Name Address ID/FEI Business Operations Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd 420823163 API MANUFACTURE