PINWORM  MEDICINE- pyrantal pamoate suspension 
Reese Pharmaceutical Company

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

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


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

image of carton

PINWORM   MEDICINE
pyrantal pamoate suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10956-618
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRANTEL PAMOATE (UNII: 81BK194Z5M) (PYRANTEL - UNII:4QIH0N49E7) PYRANTEL PAMOATE144 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 CPS) (UNII: 4GFU244C4J)  
POVIDONE (UNII: FZ989GH94E)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (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:10956-618-0130 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart357B01/01/2007
Labeler - Reese Pharmaceutical Company (004172052)
Registrant - Elge Inc (610655136)
Establishment
NameAddressID/FEIBusiness Operations
Elge Inc610655136manufacture

Revised: 3/2011
Document Id: b1025890-f97a-4f33-9000-9dd9de583da5
Set id: f43e373e-209b-45a0-9102-537c2c3c51f4
Version: 1
Effective Time: 20110303
 
Reese Pharmaceutical Company