Animal NDC 57926-086-01 Panacur
Fenbendazole
Animal Product Information
| Field Name | Field Value |
|---|---|
| Animal NDC Code | 57926-086-01 |
| Proprietary Name | Panacur What is the Proprietary Name? The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes. |
| Non-Proprietary Name | Fenbendazole What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product. |
| Labeler Name | Merck Sharp & Dohme Corp. |
| Product Type | Prescription Animal Drug |
| Usage Information |
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| Active Ingredient(s) |
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| Inactive Ingredient(s) |
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| Marketing Category | NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| FDA Application Number | NADA128620 What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
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Panacur Animal Product Labeling Information
The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Table of Contents
Veterinary Indications
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).
Other
Beef Cattle Only – 4.6 mg/lb (10 mg/kg) body weight for the treatment and control of: Stomach worms (4th stage inhibited larvae): Ostertagia ostertagi (Type II Ostertagiasis); Tapeworms: Moniezia benedeni.
Do not use in dairy cattle at 10 mg/kg.
Fenbendazole (active ingred.) made in China. Formulated in France.
Distributed by: Intervet Inc (d/b/a Merck Animal Health), Madison, NJ 07940
Approved by FDA under NADA # 128-620
©2020 Intervet Inc., a subsidiary of Merck & Co. Inc.
Rev. 11/20
340358 R5
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.
EXAMPLES:
| Cattle Weight | Dose (2.3 mg/lb) | Dose 4.6 mg/lb |
|---|---|---|
| 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
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
Store at or below 25°C (77°F). Protect from freezing. Shake well before use.
Principal Display Panel - 3,785 Ml Bottle Label
panacur®
(fenbendazole)
Dewormer
for Beef & Dairy Cattle
Suspension 10%
(100 mg/mL)
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)
LOT NUMBER:
EXPIRATION DATE:
MERCK
Animal Health
359646 R3
* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.