Label: PUBLIX STOMACH RELIEF ULTRA STRENGTH- bismuth subsalicylate suspension

  • NDC Code(s): 41415-707-12
  • Packager: PUBLIX SUPER MARKETS, INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 7, 2023

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  • Active ingredient (in each 15 mL dose)

    Bismuth subsalicylate 525 mg

  • Purposes

    Upset stomach reliever and antidiarrheal

  • 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: Contains salicylate.Do not take if you are

    ▪
    allergic to salicylates (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 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 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 right away (1-800-222-1222).

  • Directions

    •
    shake well before use
    •
    only use dose cup provided
    •
    adults and children 12 years and over:
    •
    15 mL (1 dose) every ½ hour or 30 mL (2 doses) every hour as needed for diarrhea/traveler’s diarrhea
    •
    15 mL (1 dose) every ½ hour as needed overindulgence (upset stomach, heartburn, indigestion, nausea)
    •
    do not exceed 8 doses (120 mL) in 24 hours
    •
    use until diarrhea stops but not more than 2 days
    •
    children under 12 years: ask a doctor
    •
    drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • Other information

    •
    each 15 mL dose cup contains: potassium 7 mg, sodium 5 mg
    •
    salicylate 230 mg
    •
    low sodium
    •
    sugar free
    •
    store at room temperature
    •
    protect from freezing
    •
    avoid excessive heat (over 104°F or 40°C)
  • Inactive ingredients

    carboxymethylcellulose sodium, D&C Red No. 22, D&C Red No. 28, flavor, microcrystalline cellulose, potassium hydroxide, potassium sorbate, purified water, salicylic acid, simethicone emulsion, sodium benzoate, sucralose, xanthan gum

  • Questions or comments?

    1-866-467-2748

    Do not use if imprinted shrink band is missing or broken.

  • Principal Display Panel

    NDC 41415-707-12

    *Compare to the active ingredient in Pepto-Bismol® Ultra Strength

    Ultra Strength

    pink bismuth

    bismuth subsalicylate

    Upset Stomach Reliever/Antidiarrheal

    Natural Cherry flavor

    Relieves:

    ▪
    Nausea
    ▪
    Heartburn
    ▪
    Indigestion
    ▪
    Upset Stomach
    ▪
    Diarrhea

    12 FL. OZ. (354 mL)

    2X CONCENTRATED FORMULA**

    Distributed by:

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

    PUBLIX Ultra Strength pink bismuth cherry flavor 354 mL
  • INGREDIENTS AND APPEARANCE
    PUBLIX STOMACH RELIEF  ULTRA STRENGTH
    bismuth subsalicylate suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41415-707
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE, SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE525 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    D&C RED NO. 22 (UNII: 1678RKX8RT)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorPINK (viscous) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41415-707-12354 mL in 1 BOTTLE; Type 0: Not a Combination Product10/24/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00810/24/2022
    Labeler - PUBLIX SUPER MARKETS, INC (006922009)
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