ANTHELBAN V- pyrantel pamoate suspension 
Phoenix Pharmaceutical Inc./ Clipper Distributing, Inc.

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Anthelban®V
(pyrantel pamoate)
Active Ingredient: 50 mg of pyrantel base as pyrantel pamoate per mL
Equine Anthelminitic Suspension

FOR ANIMAL USE ONLY

Pyrantel Pamoate Equine is a suspension of pyrantel pamoate in a palatable mint-flavored vehicle. Each mL contains 50 mg of pyrantel base as pyrantel pamoate.

Pyrantel pamoate is a compound belonging to a family classified chemically as tetrahydropyrimidines. It is a yellow, water-insoluble crystalline salt of the tetrahydropyrimidine base and pamoic acid containing 34.7% base activity. The chemical structure and name are given below:

image of structure

(E)-1,4,5,6-Tetrahydro-1-methyl-2-[2-(2-thienyl)vinyl] pyrimidine 4,4’ methylenebis [3-hydroxy-2-naphthoate] (1:1)

INDICATIONS:

For the removal and control of mature infections of large strongyles (Strongylus vulgaris, S. edentatus, S. equinus); pinworms (Oxyuris equi); large roundworms (Parascaris equorum); and small strongyles in horses and ponies.

DIRECTIONS FOR USE:

Pyrantel Pamoate Equine may be administered by means of a stomach tube, dose syringe or by mixing into the feed. Administer 3 mg pyrantel base per pound of body weight (6 mL Pyrantel Pamoate Equine) per 100 lb body weight). It is recommended that severely debilitated animals not be treated with this preparation. For maximum control of parasitism, it is recommended that foals (2-8 months of age) be dosed every 4 weeks. To minimize potential hazard that the mare may pose to the foal, she should be treated 1 month prior to anticipated foaling date followed by retreatment 10 days to 2 weeks after birth of foal. Horses over 8 months of age should be routinely dosed every 6 weeks.

Stomach Tube - Measure the appropriate dosage of Pyrantel Pamoate Equine and mix in the desired quantity of water. Protect drench from direct sunlight and administer to the animal immediately following mixing. Do not attempt to store diluted suspension. Pyrantel Pamaote Equine is inactive against the common horse bot (Gastrophilus spp). However, Pyrantel Pamoate Equine may be administered concurrently with carbon disulfide observing the usual precautions with carbon disulfide.

Dose Syringe - Draw the appropriate dosage of Pyrantel Pamoate Equine into a dose syringe and administer to the animal. Do not expose Pyrantel Pamoate Equine to direct sunlight.

Feed - Mix the appropriate dosage of Pyrantel Pamoate Equine in the normal grain ration. Fasting of animals prior to or following treatment is not required.

STORAGE:

Store at room temperature between 15°- 30°C (59°-86°F).

CAUTION:

THIS PRODUCT IS A SUSPENSION AND AS SUCH WILL SEPARATE. TO INSURE UNIFORM RE-SUSPENSION AND TO ACHIEVE PROPER DOSAGE, IT IS EXTREMELY IMPORTANT THAT THE PRODUCT BE SHAKEN AND STIRRED THOROUGHLY BEFORE EVERY USE.

WARNING:

Not for horses or ponies intended for food. Keep out of the reach of children.

SAFETY AND EFFICACY:

Pyrantel Pamoate Equine is well tolerated by horses and ponies of all ages. Adverse drug response was not observed when dose rates up to 60 mg pyrantel base per lb of body weight were administered by stomach tube nor when 3 mg base per lb was given by intratracheal injection. The reproductive performance of pregnant mares and stud horses dosed with pyrantel pamoate suspension has not been affected. Critical (worm count) studies in horses demonstrated that pyrantel pamoate suspension administered at the recommended dosage was efficacious against mature infections of Strongylus vulgaris (>90%), S. edentatus (69%), S. equinus (>90%), Oxyuris equi (81%), Parascaris equorum (>90%), and small strongyles (>90%).

CAUTION:

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

PRESENTATION:

16 fl oz (473 mL) and 32 fl oz (960 mL).

Iss. 12-03

Phoenix Pharmaceutical, Inc.

Manufactured for:

Clipper Distributing Company, LLC

St. Joseph, MO 64507

Manufactured by:

First Priority, Inc.

Elgin, IL U.S.A.

ANADA 200-353, Approved by FDA

image of 16 oz bottle/case label

16 oz bottle/case label (Iss. 06-09)

image of 32 oz bottle/case label

32 oz bottle/case label (Rev. 07-10)

ANTHELBAN  V
pyrantel suspension
Product Information
Product TypePRESCRIPTION ANIMAL DRUG LABELItem Code (Source)NDC:57319-557
Route of AdministrationoralDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRANTEL PAMOATE (PYRANTEL) PYRANTEL50 mg  in 1 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57319-557-2112 in 1 CASE
1473 mL in 1 BOTTLE, PLASTIC
2NDC:57319-557-2212 in 1 CASE
2946 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANADAANADA20035303/25/200711/30/2013
Labeler - Phoenix Pharmaceutical Inc./ Clipper Distributing, Inc. (150711039)
Establishment
NameAddressID/FEIBusiness Operations
First Priority, Incorporated179925722manufacture
Establishment
NameAddressID/FEIBusiness Operations
Hangzhou Minsheng Pharmaceutical420559965api manufacture

Revised: 7/2014
 
Phoenix Pharmaceutical Inc./ Clipper Distributing, Inc.