Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID b810b184-047a-442e-9de0-67df043fabca
Route
ORAL
Published
Effective Date 2015-11-12
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 Mpa.s) Povidones Dimethicone Sodium Benzoate Sodium Citrate, Unspecified Form Saccharin Sodium Sorbitol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2007-01-01
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: 2026-02-15T11:56:02.935485 · Updated: 2026-03-14T22:54:12.692887