Pepto Tablet, Chewable
FDA Label NDC 58933-446

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Procter & Gamble Manufactura S De Rl De Cv for the product Pepto (NDC 58933-446). 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, uses, ask a doctor or pharmacist before use if the child is, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

MADE IN MEXICO
DIST. BY PROCTER & GAMBLE,
CINCINNATI, OH 45202

Active Ingredient (In Each Tablet)

Calcium carbonate 400 mg

Purpose

Antacid

Ask A Doctor Or Pharmacist Before Use If The Child Is

  • presently taking a prescription drug. Antacids may interact with certain prescription drugs.

Otc - Stop Use

Stop use and ask a doctor if symptoms last more than two weeks.

Otc - Keep Out Of Reach Of Children

Keep this and all drugs out of the reach of children.

Directions

  • find the right dose on chart below based on weight (preferred), otherwise use age
  • repeat dose as needed
  • do not take more than 3 tablets (ages 2-5) or 6 tablets (ages 6-11) in a 24-hour period, or use the maximum dosage for more than two weeks, except under the advice and supervision of a doctor.

    • Dosing Chart

    Weight (lbs.)AgeDose
    under 24under 2 yrsask a doctor
    24-472-5 yrs1 tablet
    48-956-11 yrs2 tablets

Questions?

1-800-944-9606

* Please review the disclaimer below.