Label: PANACUR- fenbendazole suspension
- NDC Code(s): 57926-087-01
- Packager: Merck Sharp & Dohme Corp.
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Animal Drug Application
Updated September 10, 2021
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INDICATIONS AND DOSAGE:
Horses – 2.3 mg/lb (5 mg/kg): for the treatment and control of large strongyles (Strongylus edentatus, S. equinus, S. vulgaris, Triodontophorus spp.), small strongyles (Cyathostomum spp., Cylicocyclus spp., Cylicostephanus spp., Cylicodontophorus spp.), and pinworms (Oxyuris equi). 4.6 mg/lb (10 mg/kg): for the treatment and control of ascarids (Parascaris equorum).
Beef and Dairy Cattle – 2.3 mg/lb (5 mg/kg): 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).
- STORAGE AND HANDLING
Horses and Beef and Dairy Cattle:
Administer orally by suitable dosing syringe. Insert nozzle of syringe through the interdental space and deposit the drug on the back of the tongue by depressing the plunger. The drug may also be administered by stomach tube.
Animal 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, http://www.fda.gov/reportanimalae.
OTHER WARNINGS: Do not use in horses intended for human consumption.
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.
SPL UNCLASSIFIED SECTION
Fenbendazole (active ingred.) made in China.
Formulated in France.
Intervet Inc. (d/b/a Merck Animal Health) Madison, NJ 07940
Approved by FDA under NADA # 104-494
Approved by FDA under NADA # 128-620
©2020 Intervet Inc., a subsidiary of Merck & Co. Inc.
PRINCIPAL DISPLAY PANEL - 1,000 mL Bottle Label
Horse & 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.
1,000 mL (33.8 fl oz)
INGREDIENTS AND APPEARANCE
Product Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:57926-087 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:57926-087-01 1000 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA128620 11/15/1977 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