Label: STOMACH RELIEF - MAXIMUM STRENGTH- bismuth subsalicylate liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 30, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient
    (in each 30 mL dose cup or 2 tablespoons)

    Bismuth subsalicylate    1050 mg

  • PURPOSE

    Purposes
    Bismuth subsalicylate .............. Upset stomach reliever
                                                           and antidiarrheal

  • INDICATIONS & USAGE

    Uses relieves ■ travelers' diarrhea ■ diarrhea
    ■ upset stomach due to overindulgence of food and
    drink including: ■ heart burn ■ indigestion
    ■ nausea ■ gas ■ belching

  • WARNINGS

    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.

  • SPL UNCLASSIFIED SECTION

    Allergy alert: Contains salicylate. Do not take if you are
    ■ allergic to salicylates (including aspirin)
    ■ taking other salicylate products

  • DO NOT USE

    Do not use if you have ■ an ulcer
    ■ a bleeding problem    ■ black or bloody stool

  • ASK DOCTOR

    Ask a doctor before use if you have
    ■ fever ■ mucus in stool

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are
    taking any drug for ■ anticoagulation (thinning of the blood)
    ■ diabetes  ■ gout   ■ arthritis

  • WHEN USING

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

  • STOP USE

    Slop use and ask a doctor if
    ■ diarrhea lasts more than 2 days
    ■ symptoms get worse or last more than 2 days
    ■ ringing in the ears or loss of hearing occurs

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.
    In case of overdose, get medical help or contact a Poison
    Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions ■ Shake well before use
    ■ use dose cup or tablespoon (TBSP)
    ■ adults and children 12 years and over: 1 dose
       (30 mL or 2 TBSP) every 1 hour as needed
    ■ do not exceed 4 doses (120 mL or 8 TBSP) 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 SAFETY INFORMATION

    Other information
    ■ each 30 ml dose cup contains:
    sodium 13 mg, salicylate 455 mg
    ■ protect from freezing ■ avoid excessive heat
    (over 104°F or 40°C) ■ low sodium

  • INACTIVE INGREDIENT

    Inactive ingredients benzoic acid, D&C red #22,
    D&C red # 28, flavor, purified water, saccharin sodium,
    salicylic acid, sodium salicylate, xantham gum

  • QUESTIONS

    Questions? 1-877-798-5944

  • Principal Display Panel

    AP SAFE                               NDC 76281-538-26

    *COMPARE TO
    the active ingredient in
    PEPTO-BISMOL™
    MAXIMUM STRENGTH

    Stomach
    Relief
    Bismuth Subsalicylate
    Antidiarrheal / Upset Stomach Reliever

    Maximum Strength

    5 Symptom Relief of:
    ● Nausea ● Heartburn ●Indigestion
    ● Upset stomach ● Diarrhea

    8 FL OZ (237 mL)

    TAMPER EVIDENT: Do not use if imprinted
         shrinkband is missing or broken

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

    Manufactured by: AptaPharma Inc.,                         Made in USA
    1533 Union Ave.                                                    AP-LR-12    REV01
    Pennsauken, NJ 08110

    3 76281 53826 7                 PEEL

                                             HERE

    76281-538-26 Max 8OZ

                                                  Stomach Relief - Maximun Strength by AptaPharma Inc.

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  • INGREDIENTS AND APPEARANCE
    STOMACH RELIEF - MAXIMUM STRENGTH 
    bismuth subsalicylate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76281-538
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE1050 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    D&C RED NO. 22 (UNII: 1678RKX8RT)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    SODIUM SALICYLATE (UNII: WIQ1H85SYP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Colorpink (color suspension) Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76281-538-26237 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00810/01/2018
    Labeler - AptaPharma Inc. (790523323)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(76281-538)