PANACUR- fenbendazole suspension

Panacur by

Drug Labeling and Warnings

Panacur by is a Animal medication manufactured, distributed, or labeled by Merck Sharp & Dohme Corp., Intervet Production S.A., Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Suspension 10% (100 mg/mL)

DOSAGE

Beef and Dairy Cattle

5 mg/kg (2.3 mg/lb) for the removal and control of:

Lungworm: (Dictyocaulus viviparus)

Stomach worm (adults): Ostertagia ostertagi (brown stomach worm).

Stomach worm (adults & 4th stage larvae): Haemonchus contortus/placei (barberpole worm), Trichostrongylus axei (small stomach worm).

Intestinal worm (adults & 4th stage larvae): Bunostomum phlebotomum (hookworm), Nematodirus helvetianus (threadnecked intestinal worm), Cooperia punctata and C. oncophora (small intestinal worm), Trichostrongylus colubriformis (bankrupt worm), Oesophagostomum radiatum (nodular worm).

Beef Cattle Only

10 mg/kg (4.6 mg/lb) for the removal and control of:

Stomach worm (4th stage inhibited larvae): Ostertagia ostertagi (Type II Ostertagiasis)

Tapeworm: Moniezia benedeni

Do not use in dairy cattle at 10 mg/kg.

DIRECTIONS

Determine the proper dose according to estimated body weight. Administer orally. In beef and dairy cattle, the recommended dose of 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 dosage of 10 mg/kg for treatment of Ostertagiasis Type II (inhibited 4th stage larvae) or tapeworm is achieved when 4.6 mL of the drug is given for each 100 lb of body weight.

EXAMPLES:	Dose (5 mg/kg)	Dose (10 mg/kg)	Cattle Weight
	2.3 mL	4.6 mL	100 lb
	4.6 mL	9.2 mL	200 lb
	6.9 mL	13.8 mL	300 lb
	9.2 mL	18.4 mL	400 lb
	11.5 mL	23.0 mL	500 lb
	23.0 mL	46.0 mL	1,000 lb
	34.5 mL	69.0 mL	1,500 lb

Under conditions of continued exposure to parasites, retreatment may be needed after 4-6 weeks. There are no known contraindications to the use of the drug in cattle. For dairy cattle, there is no milk withdrawal period at 5 mg/kg.

STORAGE AND HANDLING

Store at or below 25°C (77°F).

Protect from freezing.

Shake well before use.

RESIDUE WARNINGS

Cattle must not be slaughtered for human consumption within 8 days following treatment. For dairy cattle, there is no milk withdrawal period at the 5 mg/kg dose. Do not use at 10 mg/kg in dairy cattle. Dose rate of 10 mg/kg is for beef cattle only. Dose rate of 10 mg/kg in dairy cattle could result in violative residues in milk. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

CAUTION

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

SPL UNCLASSIFIED SECTION

Keep this and all medication out of the reach of children.

SPL UNCLASSIFIED SECTION

Made in France
Distributed by: Intervet Inc., Millsboro, DE 19966

NADA # 128-620, Approved by FDA

PRINCIPAL DISPLAY PANEL - 3,785 mL Label

intervet

panacur®
(fenbendazole)

Dewormer for Beef & Dairy Cattle Suspension 10% (100 mg/mL)

RESIDUE WARNINGS: Cattle must not be slaughtered for human
consumption within 8 days following treatment. For dairy cattle,
there is no milk withdrawal period at the 5 mg/kg dose. Do not use
at 10 mg/kg in dairy cattle. Dose rate of 10 mg/kg is for beef cattle
only. Dose rate of 10 mg/kg in dairy cattle could result in violative
residues in milk. A withdrawal period has not been established for
this product in pre-ruminating calves. Do not use in calves to be
processed for veal.

CAUTION: Federal law restricts this drug to use
by or on the order of a licensed veterinarian.

Keep this and all medication out of the
reach of children.

1 Gallon (3,785 mL)

055602 LPFI240 01

INGREDIENTS AND APPEARANCE

PANACUR 
fenbendazole suspension

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 (UNII: K679OBS311)
povidone (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 - Schering Corporation (001317601)

Establishment
Name	Address	ID/FEI	Business Operations
Intervet Production S.A.		771867553	ANALYSIS, MANUFACTURE