Label: CHEWABLE STOMACH RELIEF- bismuth subsalicylate tablet, chewable

  • NDC Code(s): 41415-124-30
  • Packager: PUBLIX SUPER MARKETS INC,
  • 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 September 17, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each chewable tablet)

    Bismuth subsalicylate 262 mg

  • Purpose

    Antidiarrheal/ upset stomach reliever

  • 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 or vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

    Allergy alert

    Do not use if you are

    ▪
    allergic to salicylate (including aspirin)
    ▪
    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 the 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 or last more than 2 days
    ▪
    ringing in the ears or loss of hearing occurs
    ▪
    diarrhea lasts more than 2 days

    If pregnant or breastfeeding, 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 immediately at 1-800-222-1222

  • Directions

    ▪
    chew or dissolve tablets in mouth
    ▪
    adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed
    ▪
    do not exceed 8 doses (16 tablets) in 24 hours
    ▪
    use until diarrhea stops but not more than 2 days
    ▪
    drink plenty of clear fluids to help prevent dehydration caused by diarrhea
    ▪
    children under 12 years: ask a doctor
  • Other information

    ▪
    each tablet contains: salicylate 102 mg
    ▪
    Store at room temperature
    ▪
    avoid excessive heat
    ▪
    keep this carton for future reference on full labeling
  • Inactive ingredients

    D&C Red No. 27, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucralose.

  • Questions or comments?

    1-866-467-2748

  • PRINCIPAL DISPLAY PANEL

    Compare to active ingredient in Pepto-Bismol® Chewable Tablets*

    Pink bismuth chewable tablets

    Original flavor

    BISMUTH SUBSALICYLATE 262 mg

    ANTIDIARRHEAL/UPSET STOMACH RELIEVER

    Soothing relief for:

    •
    Heartburn
    •
    Indigestion
    •
    Upset Stomach
    •
    Nausea Diarrhea

    30 CHEWABLE TABLETS

    DO NOT USE IF INDIVIDUAL BLISTER COMPARTMENTS ARE TORN OR OPEN

    *This product is not manufactured or distributed by Procter & Gamble Inc., the distributor of Pepto-Bismol®

    DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.

    3300 PUBLIX CORPORATE PARKWAY

    LAKELAND, FL 33811

    Publix.com

    Stomach Relief BISMUTH SUBSAQLICYLATE
  • INGREDIENTS AND APPEARANCE
    CHEWABLE STOMACH RELIEF 
    bismuth subsalicylate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41415-124
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE, SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE262 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    magnesium stearate (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorPINK (light-pink) Scoreno score
    ShapeROUNDSize16mm
    FlavorWINTERGREENImprint Code RP124
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41415-124-305 in 1 CARTON06/30/2017
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33506/30/2017
    Labeler - PUBLIX SUPER MARKETS INC, (006922009)
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