SYNANTHIC BOVINE DEWORMER- oxfendazole suspension

Synanthic Bovine Dewormer by

Drug Labeling and Warnings

Synanthic Bovine Dewormer by is a Animal medication manufactured, distributed, or labeled by Boehringer Ingelheim Animal Health USA Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

NADA 140-854, Approved by FDA

For Animal Use Only

DESCRIPTION

Each mL contains 225 mg of oxfendazole. The entire contents of the 500 mL bottle treats 110 cattle weighing approximately 500 lbs each, while the entire contents of the 1000 mL bottle treats 220 cattle weighing approximately 500 lbs each.

Indications:

Synanthic Bovine Dewormer Suspension, 22.5%, is a broad-spectrum anthelmintic effective for the removal and control of the following parasites in cattle: lungworms, roundworms (including inhibited forms of Ostertagia ostertagi) and tapeworms, as indicated below:

• Lungworms:

  Dictyocaulus viviparus (Adult, L4)

• Barberpole Worms:

  Haemonchus contortus (Adult)

• Small Stomach Worms:

  Trichostrongylus axei (Adult)

• Brown Stomach Worms:

  Ostertagia ostertagi (Adult, L4, inhibited L4)

• Nodular Worms:

  Oesophagostomum radiatum (Adult)

• Hookworms:

  Bunostomum phlebotomum (Adult)

• Small Intestinal Worms:

  Cooperia punctata (Adult, L4)

• Tapeworms:

  Moniezia benedeni (Adult)

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

Administration and Dosage:

Synanthic Bovine Dewormer Suspension, 22.5%, is supplied in 500 mL and one liter packages containing 225 mg of oxfendazole per mL. The recommended dose for cattle is 2.05 mg/lb (4.5 mg/kg) of body weight. Synanthic Bovine Dewormer Suspension, 22.5%, should be administered orally by accurate dose syringe at the rate of 1 mL per 110 lb (50 kg) of body weight. This product should be shaken well immediately prior to use.

Remove Cap and Protective Seal and Replace with Draw Off Cap Prior to Use. Do Not Squeeze Sides of Bottle. Replace the Draw Off Cap with the Initial Cap after Use.

Directions:

Determine the proper dose according to estimated body weight. Administer orally. The recommended dose of 2.05 mg/lb (4.5 mg/kg) is achieved when 1 mL of the suspension is given for each 110 lb (50 kg) of body weight.

Examples:

• Cattle Weight:

  Dose

• 110 lb (50 kg):

  1.0 mL

• 220 lb (100 kg):

  2.0 mL

• 330 lb (150 kg):

  3.0 mL

• 440 lb (200 kg):

  4.0 mL

• 550 lb (250 kg):

  5.0 mL

• 660 lb (300 kg):

  6.0 mL

• 770 lb (350 kg):

  7.0 mL

• 880 lb (400 kg):

  8.0 mL

• 990 lb (450 kg):

  9.0 mL

• 1100 lb (500 kg):

  10.0 mL

Treatment may be repeated in 4–6 weeks.

Caution:

Use only as directed. Keep out of reach of children. Not for human use.

Residue Warnings:

Cattle must not be slaughtered until 7 days after treatment. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age.

Safety:

There are no contraindications for the use of Synanthic Bovine Dewormer Suspension, 22.5%, in cattle.

Storage:

Store at or below 25°C (77°F). Brief excursions are permitted up to 30°C (86°F). Do not freeze.

SPL UNCLASSIFIED SECTION

Restricted Drug (California) – Use Only as Directed

© 2015 Boehringer Ingelheim Vetmedica, Inc. All Rights Reserved.

Synanthic is a registered trademark of Boehringer Ingelheim Vetmedica, Inc.

84847666
383207-01

SPL UNCLASSIFIED SECTION

Manufactured for:
Boehringer Ingelheim Vetmedica, Inc.
St. Joseph, MO 64506 U.S.A.

Principal Display Panel – Container Label 500 mL

NDC: 0010-3832-01

Synanthic®

oxfendazole oral suspension

Bovine Dewormer Suspension, 22.5%

For Animal Use Only

Net Contents: 500 mL

NADA 140-854, Approved by FDA

Principal Display Panel – Display Carton 500 mL

NDC: 0010-3832-01

Synanthic®

oxfendazole oral suspension

Bovine Dewormer Suspension, 22.5%

For Animal Use Only

Net Contents: 500 mL

NADA 140-854, Approved by FDA

INGREDIENTS AND APPEARANCE

SYNANTHIC BOVINE DEWORMER 
oxfendazole suspension

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 0010-3832
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXFENDAZOLE (UNII: OMP2H17F9E) (OXFENDAZOLE - UNII:OMP2H17F9E)	OXFENDAZOLE	225 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0010-3832-01	1 in 1 CARTON
1		500 mL in 1 BOTTLE, PLASTIC
2	NDC: 0010-3832-02	1 in 1 CARTON
2		1000 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA140854	12/21/2010

Labeler - Boehringer Ingelheim Vetmedica, Inc. (007134091)

Registrant - Boehringer Ingelheim Vetmedica, Inc. (007134091)