PINWORM MEDICINE- pyrantal pamoate suspension

Pinworm by

Drug Labeling and Warnings

Pinworm by is a Otc medication manufactured, distributed, or labeled by Proficient Rx LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in each mL)

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

PURPOSE

Purpose

Anthelimintic

INDICATIONS & USAGE

Uses for the treatment of pinworns

WARNINGS

Warnings  Do not exceed recommended dosage

ASK DOCTOR

Ask a doctor before use if

• you're pregnant
• have liver disease
  

WHEN USING

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

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

DOSAGE & ADMINISTRATION

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 INGREDIENT

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PINWORM  MEDICINE
pyrantal pamoate suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63187-586(NDC:10956-618)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRANTEL PAMOATE (UNII: 81BK194Z5M) (PYRANTEL - UNII:4QIH0N49E7)	PYRANTEL	144 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	BANANA	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63187-586-30	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part357B	01/01/2007

Labeler - Proficient Rx LP (079196022)

Establishment
Name	Address	ID/FEI	Business Operations
Proficient Rx LP		079502574	RELABEL(63187-586)