Label: PEP TUM- bismuth subsalicylate tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 22, 2017

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  • Active ingredient (in each tablet)

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

  • Purpose

    Antidiarrheal/Antacid

  • Uses

    relieves

    • travelers’ diarrhea
    • diarrhea
    • upset stomach due to overindulgence in food and drink including:
    • heartburn
    • indigestion
    • nausea
    • gas
    • belching
    • fullness
  • 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 or pharmacist before use if you

    • are taking any drug for anticoagulation (thinning 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, but harmless, darkening of the stool and/or tongue may occur.

    If pregnant or breast-feeding,

    ask a health professional before use.

  • Keep Out of Reach of Children.

    In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • chew or dissolve in mouth
    • Adults and children 12 years and over: 2 tablets (1 dose) every ½ hour or 4 tablets (2 doses) every hour as needed for diarrhea
    • 2 tablets (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
    • do not exceed 8 doses (16 tablets) in 24 hours
    • use until diarrhea stops but not more than 2 days
    • Children under 12 years of age: ask a doctor
    • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • Inactive Ingredients

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

  • Other Information

    • Phenylketonurics: contains phenylalanine 1.1mg per tablet
      Calcium content per tablet: 73mg
    • store at room temperature 15°– 30°C (59°– 86°F)
    • avoid excessive heat (over 40°C or 104°F)
    • do not use if cellophane unit is torn
  • Package/Label Principal Display Panel

    Pep Tum

    Pep Tum

  • INGREDIENTS AND APPEARANCE
    PEP TUM 
    bismuth subsalicylate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53117-046
    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)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    DEXTRATES (UNII: G263MI44RU)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize17mm
    FlavorImprint Code RH046
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53117-046-8530 in 1 CARTON12/23/2014
    11 in 1 CELLO PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00812/23/2014
    Labeler - First Aid Direct (962283128)
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