Drug Facts

Drug Facts
SPL v8
SPL
SPL Set ID 7fd58448-6846-4d8e-994c-d0ca2fd38e68
Route
ORAL
Published
Effective Date 2015-11-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrantel (144 mg)
Inactive Ingredients
Citric Acid Monohydrate Glycerin Lecithin, Soybean Magnesium Aluminum Silicate Methylcellulose (100 Cps) Povidone Dimethicone Sodium Benzoate Sodium Citrate Saccharin Sodium Sorbitol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-11-16
Description

Active ingredient (in each mL) Pyrantel Pamoate  144mg/mL (the equivalent of 50mg pyrantel base)

Medication Information

Warnings and Precautions

Warnings  Do not exceed recommended dosage

Indications and Usage

Uses for the treatment of pinworns

Dosage and 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

Description

Active ingredient (in each mL) Pyrantel Pamoate  144mg/mL (the equivalent of 50mg pyrantel base)

Section 50565-1

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

Section 50567-7

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.

Section 50569-3

Ask a doctor before use if

  • you're pregnant
  • have liver disease

Section 51727-6

Inactive ingredients

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

Section 51945-4

Section 55105-1

Purpose

Anthelimintic

Section 55106-9

Active ingredient (in each mL)

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

Structured Label Content

Indications and Usage (34067-9)

Uses for the treatment of pinworns

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

Warnings  Do not exceed recommended dosage

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

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.

Section 50569-3 (50569-3)

Ask a doctor before use if

  • you're pregnant
  • have liver disease

Section 51727-6 (51727-6)

Inactive ingredients

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Anthelimintic

Section 55106-9 (55106-9)

Active ingredient (in each mL)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:54.416594 · Updated: 2026-03-14T23:06:01.213422