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]

STORAGE AND HANDLING

Shake well before use.
Store at or below 25° C (77° F)
Protect from freezing.

DOSAGE

Horses

5 mg/kg (2.3 mg/lb) for the 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).

EXAMPLE: 2.3 mL/100 lb; 23 mL/1,000 lb

10 mg/kg (4.6 mg/lb) for the control of ascarids (Parascaris equorum). EXAMPLE: (10 mg/kg); 2.3 mL/50 lb; 23 mL/500 lb

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 (thread-necked 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 ll Ostertagiasis).

Tapeworm: Moniezia benedeni.

Do not use in dairy cattle at 10 mg/kg

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 the 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: (Horses and Cattle)

Dose (5 mg / kg)	Dose (10 mg / kg)	Animal 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

DIRECTIONS

Beef and Dairy Cattle and Horses

Determine the proper dose according to estimated body weight. 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. There are no known contraindications to the use of the drug in cattle or horses. For dairy cattle, there is no milk withdrawal period at 5 mg/kg. Panacur® (fenbendazole) Suspension 10% is approved for use concomitantly with an approved form of trichlorfon. Trichlorfon is approved for the treatment of stomach bots (Gasterophilus spp.) in horses. Refer to the manufacturer's label for directions for use and cautions for trichlorfon.

Regular deworming at intervals of six to eight weeks may be required for horses.

Under conditions of continued exposure to parasites, retreatment of cattle may be needed after 4-6 weeks.

SPL UNCLASSIFIED SECTION

Made in France
XXXXXX LPI240 01 faf

Distributed by: Intervet Inc.
Millsboro, DE 19966

NADA #s 104-494 and
128-620, Approved by FDA

PRINCIPAL DISPLAY PANEL - 1,000 mL label

intervet

panacur®
(fenbendazole)

Horse & Cattle Dewormer

Suspension 10%
(100 mg/mL)

RESIDUE WARNINGS:
Do not use in horses intended for human con-
sumption. Cattle must not be slaughtered for
human consumption within 8 days following
treatment. For dairy cattle, there is no milk with-
drawal 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.

1,000 mL (33.8 fl oz)

050546 LPFI240 01

INGREDIENTS AND APPEARANCE

PANACUR 
fenbendazole suspension

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 (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: 57926-087-01	1000 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