LevaMed Soluble Drench Powder

Manufacturer
Bimeda, Inc.
Effective date
2024-12-05
Label type
OTC ANIMAL DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 02:43:57

Label at a glance#

ProductLevaMed Soluble Drench Powder
Active ingredientLEVAMISOLE HYDROCHLORIDE
Label structure9 sections

Storage and handling

STORAGE: Store at 20°C-25°C (68°F-77°F), excursions permitted between 15°C-30°C (59°F-86°F). CONTACT INFORMATION: To report adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Bimeda, Inc. at 1-888-524-6332. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae

Label contents#

Full prescribing information#

DESCRIPTION SECTION

LevaMedTM
(levamisole hydrochloride)
Soluble Drench Powder
CATTLE AND SHEEP DEWORMER FOR ORAL USE
Anthelmintic

HOW SUPPLIED SECTION

The 52 g packet contains 46.8 grams of levamisole hydrochloride activity.
The 403 g bottle contains 362.7 grams of levamisole hydrochloride activity.
The 605 g bottle contains 544.5 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 SECTION

INDICATIONS:
LevaMed (levamisole hydrochloride) Soluble Drench Powder is a broad spectrum anthelmintic and is effective against the following adult nematode infections 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
Approved by FDA under ANADA # 200-386

DOSAGE & ADMINISTRATION SECTION

DOSAGE AND ADMINISTRATION

52 g pouch

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.

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.

DOSAGE AND ADMINISTRATION
403 g
When you are ready to deworm your cattle or sheep, add 2 liters of water to the solution in this bottle.
Swirl to mix thoroughly before using. If any solution is left over, it may be stored at up to 25°C for up to 3 months in this tightly capped bottle. Shake well before using.

Month ______ Day _______ Year _______
Administer as a single drench at a dose of 8 mg/kg body weight as follows:

image descriptionimage description

DOSAGE AND ADMINISTRATION

605 g
When you are ready to deworm your cattle or sheep, add 3 liters of water to the solution in this bottle.
Swirl to mix thoroughly before using. If any solution is left over, it may be stored at up to 25°C for up to 3 months in this tightly capped bottle. Shake well before using.

Month ______ Day _______ Year _______
Administer as a single drench at a dose of 8 mg/kg body weight as follows:

image descriptionimage description

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 weigh estimates are essential for proper performance of this product.

Cattle and sheep maintained under conditions of constant helminth exposure may require treatment within 2 to 4 weeks after the first treatment.

RESIDUE WARNING SECTION

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 SECTION

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.

WARNINGS 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/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.

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

STORAGE AND HANDLING SECTION

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

CONTACT INFORMATION: To report adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Bimeda, Inc. at 1-888-524-6332. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61133-0270-1LevaMed Soluble Drench Powder52 g in 1 POUCHPOWDER527
61133-0270-2LevaMed Soluble Drench Powder403 g in 1 JUGPOWDER4037
61133-0270-3LevaMed Soluble Drench Powder605 g in 1 JUGPOWDER6057

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61133-0270LEVAMED SOLUBLE DRENCH POWDER (LEVAMISOLE HYDROCHLORIDE) POWDER [BIMEDA, INC.]73 package rows20241207_a5cd77e0-af84-4ef6-b0bf-b3dc706352c3.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
LEVAMISOLE HYDROCHLORIDEACTIVE INGREDIENTDL9055K8091
LEVAMISOLEACTIVE MOIETY2880D3468G1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61133-027061133-0270-1, 61133-0270-2, 61133-0270-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
LEVAMISOLE HYDROCHLORIDEDL9055K809ACTIM

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.