Label: STOMACH RELIEF LIQUID MAXIMUM STRENGTH- bismuth subsalicylate suspension

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/13

If you are a consumer or patient please visit this version.

  • Active ingredients

    Bismuth Subsalicylate 525 mg

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  • Purpose

    upset stomach
    reliever-antidiarrheal

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  • Uses

    relieves, upset stomach, heartburn
    indigestion, diarrhea, nausea

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  • 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- taking other salicylate products,

    allergic to salicylates (including aspirin)

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  • Do not use if you have

    an ulcer, a bleeding problem, bloody or black stool

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  • Ask a doctor before use if you have

    fever, mucus in stool

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

    anticoagulation (thinning blood)
    diabetes, gout, arthritis

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  • When using this product

    a temporary, but harmless,
    darkening of the stool and-or tongue may occur

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  • 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

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  • If pregnant or breast-feeding,

    ask a health professional before use.

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  • Keep this and all drugs out of the reach of children

    In case of accidental overdose, seek professional
    assistance or contact a Poison Control Center
    immediately.

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  • Directions

    shake well before use
    for accurate dosing, use dose cup
    adults and children 12 years and over:
    1 dose (2 tablespoons or 30 ml) every hour as needed

     do not exceed 4 doses
    (8 tablespoons or 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

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  • Other information

    each tablespoon contains: sodium 6 mg
    sugar free, low sodium, keep tightly closed
    avoid excessive heat (over 104˚F or 40˚C)
    protect from freezing.
    Total salicylate per tablespoon, 236 mg
    Visit www.peptic-drug-facts.com

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  • Inactive ingredients

    benzoic acid, flavor,
    magnesium aluminum silicate, methyl cellulose, purified
    water, red 22, red 28, saccharin sodium, salicylic acid,
    sodium salicylate, sorbic acid

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  • Principal Display Panel

    COMPARE TO PEPTO BISMOL ACTIVE INGREDIENT

    NDC 49348-923-37

    STOMACH RELIEF LIQUID MAXIMUM STRENGTH

    SOOTHING RELIEF FOR UPSET STOMACH

    NAUSEA, INDIGESTION

    HEARTBURN AND DIARRHEA

    BISMUTH SUBSALICYLATE 525 mg

    PROTECTIVE COATING ACTION

    8 FL OZ (473 mL)

    image of label

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  • INGREDIENTS AND APPEARANCE
    STOMACH RELIEF LIQUID  MAXIMUM STRENGTH
    maximum strength pepto bismol suspension
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49348-923
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BISMUTH SUBSALICYLATE (SALICYLIC ACID) BISMUTH SUBSALICYLATE 525 mg  in 15 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZOIC ACID  
    MAGNESIUM ALUMINUM SILICATE  
    METHYLCELLULOSE (100 CPS)  
    SALICYLIC ACID  
    SACCHARIN SODIUM  
    SORBIC ACID  
    D&C RED NO. 22  
    D&C RED NO. 28  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor MINT (mint) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49348-923-37 237 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part335 11/08/2013
    Labeler - Sunmark (177667227)
    Registrant - Aaron Industries, Inc. (101896231)
    Establishment
    Name Address ID/FEI Business Operations
    Aaron Industries, Inc. 101896231 manufacture(49348-923), analysis(49348-923)
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