PINWORM MEDICINE- pyrantal pamoate suspension 
Proficient Rx LP

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient (in each mL)

Pyrantel Pamoate  144mg/mL (the equivalent of 50mg pyrantel base)

Purpose

Anthelimintic

Uses for the treatment of pinworns

Warnings  Do not exceed recommended dosage

Ask a doctor before use if

you're pregnant
have liver disease

When using this product abdominal cramps, nausea, vomiting, diarrhea, headache, or dizziness sometimes occur after taking this drug.  If any of these symptoms persist, consult a doctor.

Keep out of reach of children.  In case of overdose get medical help or contact a poison control center right away.

Directions

shake well before use
read bottle label and package insert carefully before taking this medication
treat the entire household unless otherwise advised
do not repeat treatment unless directed by a doctor
this product can be taken any time of day, with or without meals.  It may be taken alone or with milk or fruit juice.  Use of a laxative is not necessary prior to, during or after medication
it signs of pinworms persist after treatment, consult a doctor

Weight

Dosage (taken as a single dose)

Less than 25 lb. or under 2 yrs.old

Do not use unless directed by a doctor

25-37 lb.

1/2 teaspoonful

38-62 lb.

1 teaspoonful

63-87 lb.

1 1/2 teaspoonfuls

88-112 lb.

2 teaspoonfuls

113-137 lb.

2 1/2 teaspoonfuls

138-162 lb.

3 teaspoonfuls

163-187 lb.

3 1/2 teaspoonfuls

188 lb. and over

4 teaspoonfuls

Inactive ingredients

banana flavor, citric acid, gylcerin, lecithin, magnesium aluminum silicate, methylcellulose, povidone, simethicone, sodium benzoate, sodium citrate, sodium saccharin, sorbitol, and water

63187-586-30
PINWORM  MEDICINE
pyrantal pamoate suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-586(NDC:10956-618)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRANTEL PAMOATE (UNII: 81BK194Z5M) (PYRANTEL - UNII:4QIH0N49E7) PYRANTEL144 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
METHYLCELLULOSE (100 MPA.S) (UNII: 4GFU244C4J)  
POVIDONES (UNII: FZ989GH94E)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBANANAImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63187-586-3030 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart357B01/01/2007
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIBusiness Operations
Proficient Rx LP079502574RELABEL(63187-586)

Revised: 11/2015
Document Id: b810b184-047a-442e-9de0-67df043fabca
Set id: b810b184-047a-442e-9de0-67df043fabca
Version: 1
Effective Time: 20151112
 
Proficient Rx LP