Label: HEB STOMACH RELIEF MAX STRENGTH- bismuth subsalicylate suspension

  • 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 21, 2023

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  • Active ingredient (in each 30 mL dose cup)

    Bismuth subsalicylate 1050 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
  • 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

    ▪
    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 at (1-800-222-1222).

  • Directions

    •
    shake well before use
    •
    for accurate dosing use dose cup
    •
    adults and children 12 years and over: 1 dose (30 mL) every hour as needed
    •
    do not exceed 4 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 30 mL contains: sodium 20 mg
    •
    salicylate 437 mg
    •
    low sodium
    •
    sugar free
    •
    store at room temperature.
    •
    protect from freezing
    •
    avoid excessive heat (more than 104°F or 40°C).
  • Inactive ingredients

    carboxymethylcellulose sodium, D&C Red #22, D&C Red #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

  • Principal Display Panel

    *Compare to Pepto-Bismol® Maximum Strength active ingredient*

    HEB®

    Stomach Relief

    Max

    Bismuth Subsalicylate 1050 mg

    Upset Stomach Reliever/Antidiarrheal

    Multi-Symptom Relief

    Relieves:

    •
    Nausea
    •
    Heartburn
    •
    Indigestion
    •
    Upset Stomach
    •
    Diarrhea

    MADE WITH PRIDE & CARE FOR H-E-B®

    SAN ANTONIA, TX 78204

    100% GUARANTEE promise, if you aren’t completely pleased with this product, we’ll be happy to replace it or refund your money. You have our word on it.

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

    Package Label 473 mL

    HEB Max Stomach Relief 473 mL

    Package Label 236 mL

    HEB Max Bismuth Subsalicylate 236 mL
  • INGREDIENTS AND APPEARANCE
    HEB STOMACH RELIEF  MAX STRENGTH
    bismuth subsalicylate suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-770
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE1050 mg  in 30 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:37808-770-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product04/23/2019
    2NDC:37808-770-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product04/23/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33504/23/2019
    Labeler - HEB (007924756)
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