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

Drug Label Information

Updated November 18, 2024

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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 DrugM00812/01/2011
    Labeler - Unifirst First Aid Corporation (832947092)