Label: FAMILY CARE STOMACH RELIEF- bismuth subsalicylate liquid

  • 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 July 31, 2015

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  • ACTIVE INGREDIENT

    Active ingredient (in each 30 mL dose cup)                                                       Purpose

    Bismuth subsalicylate 525 mg..........................Upset stomach reliever and antidiarrheal

  • PURPOSE

    Uses

    relieves

    • diarrhea
    • heartburn
    • indigestion
    • nausea
    • gas
    • belching
    • fullness
  • 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 salicytate products
  • DO NOT USE

    Do not use if you have

    • an ulcer
    • a bleeding problem
    • bloody or black stool
  • ASK DOCTOR

    Ask a doctor before use if you have

    • fever
    • mucus in the stool

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

    • anticoagulation (thinning 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 and ask a doctor if

    • diarrhea lasts more than 2 days
    • symptoms get worse
    • ringing in the ears or loss of hearing occurs
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a 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.

  • INDICATIONS & USAGE

    Directions

    • shake well before use
    • for accurate dosing, use dose cup
    • adults and children 12 years and over: 1 dose (2 Tbsp or 30 mL) every 1/2 to 1 hour as needed
    • do not exceed 8 doses (16 Tbsp or 240 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
  • STORAGE AND HANDLING

    Other information

    • each 30 mL dose cup contains: sodium 10 mg
    • salicylate 202 mg
    • magnesium 25 mg
    • protect from freezing
    • avoid excessive heat (over 104° or 40°C)
    • low sodium
  • INACTIVE INGREDIENT

    Inactive ingredients

    FD&C Red No. 3, FD&C Red No. 40, hypromelloses, L-menthol, magnesium aluminum silicate, mint essence, polysorbate 80, propylene glycol, propylparaben, purified water, salicylic acid, sodium saccharin, sodium salicylate, sorbic acid, sucrose, xanthan gum

  • DOSAGE & ADMINISTRATION

    Distributed by:

    United Exchange Corp.

    Cerritos, CA 90703 USA

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    FAMILY CARE STOMACH RELIEF 
    bismuth subsalicylate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-626
    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
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MENTHOL (UNII: L7T10EIP3A)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    SODIUM SALICYLATE (UNII: WIQ1H85SYP)  
    SORBIC ACID (UNII: X045WJ989B)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-626-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33507/31/2015
    Labeler - United Exchange Corp. (840130579)
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