LEVAMED SOLUBLE DRENCH POWDER- levamisole hydrochloride powder

LevaMed Soluble Drench Powder by

Drug Labeling and Warnings

LevaMed Soluble Drench Powder by is a Animal medication manufactured, distributed, or labeled by Bimeda, Inc., YangZhou Pharmaceutical Co Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HOW SUPPLIED

This Packet contains 46.8 grams of levamisole hydrochloride activity.

Administer as a standard drench with standard drench syringe or administer as a concentrated drench solution with an automatic drenching syringe.

INDICATIONS & USAGE

INDICATIONS:

LevaMed Souble Drench Powder is a broad spectrum anthelmintic and is effective against the following adult nematode infecctions in cattle and sheep:

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).

CATTLE:

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

ANADA 200-386, Approved by FDA

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.

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

RESIDUE WARNING: Do not administer to cattle within 48 hours of slaughter for food. Do not administer to sheep within 72 hours of slaughter for food. To prevent residues in milk, do not administer to dairy animals of breeding age.

PRECAUTIONS

CAUTION: Muzzle foam may be observed. However, this reaction will disappear within a few hours. If this condition persists, a veterinarian should be consulted. Follow recommended dosage carefully. Consult a veterinarian before using in severely debilitated animals.

Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.

STORAGE AND HANDLING

STORAGE: Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F).

PRINCIPAL DISPLAY PANEL

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