Label: FIRST AID DIRECT PEPTUM TABS- bismuth subsalicylate tablet, chewable

  • NDC Code(s): 42961-109-01, 42961-109-02
  • Packager: Cintas Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 28, 2023

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  • Active ingredient (in each tablet)

    Bismuth subsalicylate 262 mg

    (each tablet contains 102mg 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 occurs, 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 salicylate (including asprin)
    • taking other salicylate products

    Do not use if you have

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

    Ask a doctor before use if you have

    • ​​fever
    • mucus in stool

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

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

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

    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

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

    Keep out of reach of children. ​In case of 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: ask a doctor
    • drink plenty of fluids to help prevent dehydration which may accompany diarrhea
  • Other information

    • Phenylketonurics: contains phenylalanine 1.1 mg 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

  • Inactive ingredients

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

  • Questions?

    1-800-327-2704  Monday-Friday 8:00am - 5:00pm (CDT)

  • Principal Display Panel - Box

    Pep Tum​™

    Bismuth subsalicylate

    COMPARE ACTIVE INGREDIENTS TO PEPTO-BISMOL®*

    262 mg

    SOOTHING RELIEF FOR:

    • Upset Stomach
    • Diarrhea
    • Heartburn
    • Indigestion
    • Nausea

    30 Chewable Tablets

    Box

  • INGREDIENTS AND APPEARANCE
    FIRST AID DIRECT PEPTUM TABS 
    bismuth subsalicylate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42961-109
    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
    ACACIA (UNII: 5C5403N26O)  
    ASPARTAME (UNII: Z0H242BBR1)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    DEXTRATES (UNII: G263MI44RU)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize16mm
    FlavorImprint Code RH046
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42961-109-0230 in 1 BOX10/25/2021
    1NDC:42961-109-011 in 1 CELLO PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00810/25/2021
    Labeler - Cintas Corp (056481716)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allegiant Health079501930manufacture(42961-109)
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