Medi-first Pep-t-med Tablet, Chewable
FDA Label NDC 47682-406

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Unifirst First Aid Corporation for the product Medi-first Pep-t-med (NDC 47682-406). 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, do not use if you have, ask a doctor before use if you have, ask a doctor or pharmacist if you are taking any drug for, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's Syndrome a rare but serious illness.

Allergy alert: Contains salicylate. Do not take if you are:

  • allergic to salicylates (including aspirin)
  • taking other salicylate products

    • Adults and children: (12 years and older) Chew 2 tablets every 1/2 to 1 hour or 4 tablets every hour as needed

    Children under 12 years: Do not give to children under 12 years of age.

Active Ingredient (In Each Tablet)

Bismuth Subsalicylate 262 mg
(each tablet contains 102 mg salicylate)

Purpose

Upset stomach reliever/antidiarrheal

Uses

Temporarily relieves

  • traveler's diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
    • heartburn
    • indigestion
    • nausea
    • gas
    • belching
    • fullness

Do Not Use If You Have

  • bloody or black stool
  • an ulcer
  • a bleeding problem

Ask A Doctor Before Use If You Have

  • fever
  • mucus in the stool

Ask A Doctor Or Pharmacist If You Are Taking Any Drug For

  • anticoagulation (thinning of the blood)
  • diabetes
  • gout
  • arthritis

Stop Use And Ask A Doctor If

  • symptoms get worse
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts more than 2 days

Otc - When Using

When using this product a temporary and harmless darkening of the tongue and/or stool may occur. Stool darkening should not be confused with melena.

Otc - Keep Out Of Reach Of Children

Keep this and all drugs out of reach of children. In case of accidental overdose, contact a physician or poison control center immediately.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Directions

  • do not use more than directed
  • chew or dissolve in mouth
  • use until diarrhea stops but not more than 2 days
  • drink plenty of clear fluids to help prevent dehydration, which may accompany diarrhea
  • do not exceed 16 tablets in 24 hours

Other Information

  • phenylketonurics: contains phenylalanine 1.1mg per tablet
  • each tablet contains 73mg elemental calcium
  • store at room temperature 59°-86°F (15°-30°C)
  • tamper-evident sealed packets
  • do not use any opened or torn packets

Inactive Ingredients

acacia gum, aspartame, calcium carbonate, D&C red #27, dextrates, flavoring, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide

Package Label.Principal Display Panel

220R Medi-First Label

36 Chewable Tablets

Medi-First ®

Pep-T-Med

Bismuth Subsalicylate

Chewable Tablets

Compare active ingredient to:

Pepto Bismol

Registered Trademark of Procter & Gamble

Tamper Evident Unit Dose Packets

* Please review the disclaimer below.