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 April 10, 2019

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each tablet)

    Bismuth Subsalicylate 262 mg

    (each tablet contains 102 mg salicylate)

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  • Purpose

    Upset stomach reliever/antidiarrheal

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  • Uses

    Temporarily relieves

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

    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.

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

    Keep this and all drugs out of reach of children.

    In case of accidental overdose, contact a physician or poison control center immediately.

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  • 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

    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.

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  • Other information

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

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

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  • Questions or comments?

    1-800-634-7680

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  • Medi-First Pep-T-Med Label

    36 Chewable Tablets

    Medi-First®

    PEP-T-MED

    Compare active ingredients to:

    Pepto Bismol®

    Registered Trademark of Proctor & Gamble

    Upset Stomach/Diarrhea Relief • Bismuth Subsalicylate 262mg

    Chewable Tablets

    Tamper Evident

    Medi-first PepTMed

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  • INGREDIENTS AND APPEARANCE
    MEDI-FIRST PEP-T-MED 
    bismuth subsalicylate tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:47682-406
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE 262 mg
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color pink Score no score
    Shape ROUND Size 16mm
    Flavor Imprint Code RH;046
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:47682-406-20 6 in 1 BOX 12/01/2011
    1 NDC:47682-406-69 6 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part335 12/01/2011
    Labeler - Unifirst First Aid Corporation (832947092)
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