Pyrantel Pamoate Tablet
FDA Label NDC 58988-1760

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Promex Llc for the product Pyrantel Pamoate (NDC 58988-1760). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each tablet), purpose, use, otc - ask doctor, directions, otc - keep out of reach of children, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient (In Each Tablet)

Pyrantel Pamoate 180 mg (62.5mg pyrantel base per 180 mg of pyrantel pamoate)

Purpose

Anthelmintic

Use

for the treatment of Pinworms.

Otc - Ask Doctor

Abdominal cramps, nausea, vomiting, diarrhea, headache, or dizziness sometimes occur after taking this drug. If any of these conditions persist consult a doctor

  • If you are pregnant or have liver disease, don't take this product unless directed by a doctor.

Directions

Adults, children 12 years of age and over, and children 2 years to under 12 years of age: Oral dosage is a single dose of 5 milligrams of pyrantel base per pound, or 11 milligrams per kilogram, of body weight. Do not exceed 1 gram (1000 mg).

WeightDosage (Taken as a single dose)
READ INSERT CAREFULLY BEFORE USE
25-37 lb2 tablet
38-62 lbs4 tablets
63-87 lbs6 tablets
88-112 lbs8 tablets
113-137 lbs10 tablets
138-162 lbs12 tablets
163-187 lbs14 tablets
over 188 lbs16 tablets

Take only according to directions and don't exceed recommended dosage unless directed by a doctor. Medication should only be taken one time as a single dose; do not repeat treatment unless directed by a doctor. When one individual in house hold has pinworms, the entire household should be treated unless otherwise advised. See Warnings. If any worms other than pinworms are present before or after treatment, consult a doctor. If any symptoms or pinworms are still present after treatment consult 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.

Otc - Keep Out Of Reach Of Children

Keep out of Reach of Children. In case of accidental overdose/ingestion contact a poison control center immediately.

Inactive Ingredients

Croscarmellose Sodium, Crospovidone, Dicalcium Phosphate, Magnesium Stearate, Microcrystalline Cellulose

Principal Display Panel - 20 Tablet Blister Pack Carton

VERMISOL
TABLET

Contains 20 Tablets

Principal Display Panel (20 Tablet Blister Pack Carton)

Principal Display Panel (20 Tablet Blister Pack Carton)

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