Label: STOMACH RELIEF, ULTRA 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 December 19, 2020

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.

    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

    Stop 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

  • Marc's Product Label

    NDC 68998-558-28                                          * Compare to the active

                                                                  ingredients in Pepto-BismolTM

                                                                                 Maximum Strength

    Marc's

    ULTRA STRENGTH

    Stomach Relief

    Antidiarrheal / Upset Stomach Reliever
    Bismuth subsalicylate

    5 Symptoms Relief of

    • Nausea             • Upset Stomach•

    • Heartburn        • Diarrhea

    • Indigestion

    12 FL OZ (354 mL)

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

    *Thls product is not manufactured or dlstnbuted by Procter & Gamble, Inc"
    distributor of Pepto BismolTM

    Distributed by:                                        LR-144
    Marc Glassman, Inc.
    West 130th Street
    Cleveland, OH 44130

    Lot.
    Exp.

    558-28

    res

  • INGREDIENTS AND APPEARANCE
    STOMACH RELIEF, ULTRA STRENGTH 
    bismuth subsalicylate suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68998-558
    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
    ColorpinkScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68998-558-28354 mL in 1 BOTTLE; Type 0: Not a Combination Product12/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33512/15/2020
    Labeler - Marc Glassman, Inc. (094487477)