Pinworm
FDA Label NDC 63187-586

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Proficient Rx Lp for the product Pinworm (NDC 63187-586). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - when using, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient (in each mL)

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

Otc - Purpose

Purpose

Anthelimintic

Indications & Usage

Uses for the treatment of pinworns

Warnings

Warnings  Do not exceed recommended dosage

Otc - Ask Doctor

Ask a doctor before use if

  • you're pregnant
  • have liver disease

Otc - 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.

Otc - 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

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