Label: MEDI-FIRST PEP-T-MED- bismuth subsalicylate tablet, chewable

  • NDC Code(s): 47682-406-20, 47682-406-69
  • Packager: Unifirst First Aid Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 16, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

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

  • PURPOSE

    Purpose

    Upset stomach reliever/antidiarrheal

  • INDICATIONS & USAGE

    Uses

    relieves

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

    Warnings

    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

  • DO NOT USE

    Do not use if you have

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

    Ask a doctor before use if you have

    • fever
    • mucus in the stool
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist if you are taking any drug for

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

    When using this product a temporary and harmless darkening of the tongue and/or stool may occur.

  • STOP USE

    Stop use and ask a doctor if

    • symptoms get worse or lasts for more than 2 days
    • ringing in the ears or loss of hearing occurs
    • diarrhea lasts more than 2 days
  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    In case of accidental overdose, contact a physician or poison control center right away (1-800-222-1222).

  • DOSAGE & ADMINISTRATION

    Directions

    • chew or dissolve in mouth
    • drink plenty of clear fluids to help prevent dehydration caused by diarrhea

    Adults and children: (12 years and over)

    • chew 2 tablets every 1/2 to 1 hour as needed
    • do not exceed 16 tablets in 24 hours
    • use until diarrhea stops, but not more than 2 days

    Children under 12 years: Ask a doctor

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

  • OTHER SAFETY INFORMATION

    Other information

    • phenylketonurics: contains phenylalanine 1.1mg per tablet
    • calcium content per tablet: 73 mg
    • store at room temperature 59º-86ºF (15º-30ºC)
    • tamper-evident sealed packets
    • do not use any opened or torn packets
  • INACTIVE INGREDIENT

    Inactive ingredients

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

  • QUESTIONS

    Questions or comments?

    1-800-634-7680

  • Medi-First Pep-T-Med Label

    36 Chewable Tablets

    Medi-First®

    PEP-T-MED

    Chewable Tablets

    Compare active ingredients to:

    Pepto Bismol®

    Registered Trademark of Proctor & Gamble

    Upset Stomach/Diarrhea Relief • Bismuth Subsalicylate 262mg

    Chew or crush tablets completely before swallowing.

    Do not swallow tablets whole.

    Tamper Evident

    MF PepTMed

  • INGREDIENTS AND APPEARANCE
    MEDI-FIRST PEP-T-MED 
    bismuth subsalicylate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-406
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE262 mg
    Inactive Ingredients
    Ingredient NameStrength
    ASPARTAME (UNII: Z0H242BBR1)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    DEXTRATES (UNII: G263MI44RU)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ACACIA (UNII: 5C5403N26O)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize16mm
    FlavorPEPPERMINTImprint Code RH;046
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-406-206 in 1 BOX12/01/2011
    1NDC:47682-406-696 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33512/01/2011
    Labeler - Unifirst First Aid Corporation (832947092)
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