FAMILY CARE STOMACH RELIEF (BISMUTH SUBSALICYLATE) LIQUID [UNITED EXCHANGE CORP.]

FAMILY CARE STOMACH RELIEF (BISMUTH SUBSALICYLATE) LIQUID [UNITED EXCHANGE CORP.]
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NDC 65923-626-04
Set ID 41361b56-1d2d-4368-9bef-42686e14e477
Category HUMAN OTC DRUG LABEL
Packager United Exchange Corp.
Generic Name
Product Class
Product Number
Application Number PART335
  • 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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