Label: SAFE-GUARD- fenbendazole suspension
- NDC Code(s): 57926-089-01
- Packager: Merck Sharp & Dohme Corp.
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Animal Drug Application
Drug Label Information
Updated November 19, 2024
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RESIDUE WARNING
Withdrawal Periods and Residue Warnings: Goats must not be slaughtered for human consumption within 6 days following treatment.
Because a milk discard time has not been established, do not use in lactating goats.
Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.
- VETERINARY INDICATIONS
- DOSAGE & ADMINISTRATION
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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.
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SPL UNCLASSIFIED SECTION
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.
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DOSAGE & ADMINISTRATION
Dosing Examples for Goats:
Body Weight Amount 25 lb 0.6 mL 50 lb 1.2 mL 75 lb 1.7 mL 100 lb 2.3 mL 125 lb 2.9 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.
Fenbendazole (active ingred.) made in: see imprint. Formulated in France.
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 125 mL Bottle Label
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INGREDIENTS AND APPEARANCE
SAFE-GUARD
fenbendazole suspensionProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:57926-089 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57926-089-01 125 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA128620 09/20/1983 Labeler - Merck Sharp & Dohme Corp. (001317601) Registrant - Intervet Production S.A. (771867553)
