Label: STOMACH RELIEF- bismuth subsalicylate tablet, chewable

  • NDC Code(s): 55301-319-01
  • Packager: ARMY AND AIR FORCE EXCHANGE SERVICE
  • 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 12/12

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

  • Active ingredients (in each tablet)

    Bismuth subsalicylate 262 mg 

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  • Purpose

    Upset stomach reliever/Antidiarrheal 

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  • Uses

    relieves:

    • heartburn
    • indigestion
    • upset stomach
    • nausea
    • diarrhea 
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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 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

    if you have

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

    Ask a doctor before use if you have

    • fever
    • mucus in the stool 

    Ask a doctor or pharmacist before use if you are

    taking any drug for

    • anticoagulation (thinning of the blood)
    • diabetes
    • gout
    • arthritis 

    When using this product

    a temporary, but harmless, darkening of the stool and/or tongue my occur. 

    Stop use and ask a doctor if

    • symptoms get worse
    • ringing of the ears or loss of hearing occurs
    • diarrhea lasts more than 2 days 

    If pregnant or breast-feeding,

    ask a health professional before use. 

    Keep out of reach of children.

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

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  • Directions

    • chew or dissolve in mouth
    • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
    • adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed. Do not exceed 8 doses (16 tablets) in 24 hours.
    • use until diarrhea stops, but not more than 2 days
    • children under 12 years: ask a doctor 
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  • Other information

    • each tablet contains: calcium 40 mg, salicylate 102 mg
    • store at controlled room temperature 15º-30ºC (59º-86ºF)
    • avoid excessive heat
    • store in a dry place
    • see end flap for expiration date and lot number 
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  • Inactive ingredients

    calcium carbonate, cherry flavor, D&C red #27 aluminum lake, D&C red #30 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, mannitol, povidone, sodium saccharin, stearic acid, talc 

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  • Questions or comments?

    1-800-426-9391

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  • Principal Display Panel

    exchange select™

    STOMACH
    RELIEF

    Bismuth Subsalicylate 262 mg

    Upset Stomach Reliever
    Antidiarrheal

    Compare to The Active Ingredient of Pepto-Bismol®†

    MULTI-SYMPTOM RELIEF:
    Nausea
    • Heartburn
    • Indigestion
    • Upset Stomach
    • Diarrhea

    30 TABLETS
    CHEWABLE

    †This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Pepto-Bismol®.
    50844        REV0710G31901

    SATISFACTION GUARANTEED OR YOUR MONEY BACK
    Manufactured For: Your Military Exchanges
    by: LNK International, Inc.
    Hauppauge, NY 11788

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS BROKEN, TORN OR SHOWS ANY SIGNS OF TAMPERING

    Exchange Select 44-319

    Exchange Select 44-319

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  • INGREDIENTS AND APPEARANCE
    STOMACH RELIEF 
    bismuth subsalicylate tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55301-319
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BISMUTH SUBSALICYLATE (SALICYLIC ACID) BISMUTH SUBSALICYLATE 262 mg
    Inactive Ingredients
    Ingredient Name Strength
    CALCIUM CARBONATE  
    D&C RED NO. 27  
    D&C RED NO. 30  
    MAGNESIUM STEARATE  
    MANNITOL  
    SACCHARIN SODIUM  
    STEARIC ACID  
    TALC  
    Product Characteristics
    Color PINK Score no score
    Shape ROUND Size 16mm
    Flavor CHERRY Imprint Code 44;319
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55301-319-01 5 in 1 CARTON
    1 6 in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part335 07/16/1998
    Labeler - ARMY AND AIR FORCE EXCHANGE SERVICE (001695568)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(55301-319)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(55301-319)
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