Label: LEVAMED SOLUBLE DRENCH POWDER- levamisole hydrochloride powder
- NDC Code(s): 61133-0270-1, 61133-0270-2, 61133-0270-3
- Packager: Bimeda, Inc.
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Animal Drug Application
Drug Label Information
Updated November 25, 2020
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- HOW SUPPLIED
INDICATIONS & USAGE
LevaMed Souble Drench Powder is a broad spectrum anthelmintic and is effective against the following adult nematode infecctions in cattle and sheep:
STOMACH WORMS: (Haemonchus contortus, Trichostrongylus axei, Teladorsagia circumcincta). INTESTINAL WORMS: (Trichostrongylus colubriformis, Cooperia curticei, Nematodirus spathiger, Bonostomum trigoncephalum, Oesophagostomum columbianum, Chabertia ovina), LUNGWORMS: (Dictyocaulus filaria).
STOMACH WORMS: (Haemonchus placei, Trichostrongylus axei, Ostertagia ostertagi). INTESTINAL WORMS: (Trichostrongylus longispicularis, Cooperia oncophora, Cooperia punctata, Nematodirus spathiger, Bunostomum phlebotomum, Oesophagostomum radiatum), LUNGWORMS: (Dictyocaulus viviparus).
NOT FOR USE IN HUMANS
KEEP OUT OF REACH OF CHILDREN
Restricted Drug (California) - Use Only as Directed
Approved by FDA under ANADA 200-386
DOSAGE & ADMINISTRATION
CATTLE-STANDARD DRENCH SOLUTION:
Place the contents of this packet in a 1 quart (32 fl oz) container, fill with water; swirl until dissolved. Administer as a single drench at a dose of 8 mg/kg body weight as follows:
Weight Drench Dosage Each Packet Will Treat 200 lb 1/2 fl oz 64 head 400 lb 1 fl oz 32 head 600 lb 1 1/2 fl oz 21 head 800 lb 2 fl oz 16 head
CONCENTRATED DRENCH SOLUTION:
For use with 20 mL Automatic Syringe. Place the contents of this packet in a standard household measuring container and add water to the 8 3/4 fl oz level. Swirl until dissolved. Give 2 mL (milliliter) per 100 lb body weight. Refer to the table above for the number of cattle each packet will treat.
SHEEP-STANDARD DRENCH SOLUTION:
Place the contents of this packet in a 1 gallon (128 fl oz) container, fill with water; swirl until dissolved. Administer as a single drench at a dose of 8 mg/kg body weight as follows:
Weight Drench Dosage Each Package Will Treat 50 lb 1/2 fl oz 256 head 100 lb 1 fl oz 128 head 150 lb 1 1/2 fl oz 84 head 200 lb 2 fl oz 64 head
CONCENTRATED DRENCH SOLUTION:
For use with 20 ml Automatic Syringe. Place the contents of this packet in a standard household measuring container and add water to the 17 1/2 fl oz level. Swirl until dissolved. Give 2 mL per 50 lb body weight. Refer to the table above for the number of sheep each packet will treat.
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.
NOTE: Careful weight estimates are essential for proper performance of this product. Prepare solutions as needed. However, excess solutions may be stored at up to 25°C in clean closed containers for up to 90 days without loss of anthelmintic activity.
Cattle and sheep maintained under conditions of constant helminth exposure may require treatment within 2 to 4 weeks after the first treatment.
- RESIDUE WARNING
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/flock, 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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INGREDIENTS AND APPEARANCE
LEVAMED SOLUBLE DRENCH POWDER
levamisole hydrochloride powder
Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:61133-0270 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEVAMISOLE HYDROCHLORIDE (UNII: DL9055K809) (LEVAMISOLE - UNII:2880D3468G) LEVAMISOLE 46.8 g in 52 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61133-0270-1 52 g in 1 POUCH 2 NDC:61133-0270-2 403 g in 1 JUG 3 NDC:61133-0270-3 605 g in 1 JUG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200386 12/05/2014 Labeler - Bimeda, Inc. (060492923) Registrant - Bimeda, Inc. (060492923) Establishment Name Address ID/FEI Business Operations Bimeda, Inc. 060492923 manufacture Establishment Name Address ID/FEI Business Operations YangZhou Pharmaceutical Co Ltd 544854599 api manufacture