Label: SAFE-GUARD- fenbendazole suspension
- NDC Code(s): 57926-089-01
- Packager: Schering Corporation
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Animal Drug Application
Updated September 13, 2021
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DOSAGE & ADMINISTRATION
DIRECTIONS: Administer orally. 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 body weight.
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 China. Formulated in France.
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
- SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 125 mL Bottle Label
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.
125 mL (4.2 fl oz)
INGREDIENTS AND APPEARANCE
Product 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 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:57926-089-01 125 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 - Schering Corporation (001317601) Establishment Name Address ID/FEI Business Operations Intervet Production S.A. 771867553 MANUFACTURE Establishment Name Address ID/FEI Business Operations Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd 420823163 API MANUFACTURE