Label: SIGNATURE CARE UPSET STOMACH RELIEF- bismuth subsalicylate tablet

  • 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 January 13, 2022

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  • ACTIVE INGREDIENT (in each caplet)

    Bismuth subsalicylate 262 mg


  • PURPOSE

    Upset stomach reliever and anti-diarrheal

  • USE(S)

    relieves:


    • indigestion
    • nausea
    • heartburn
    • diarrhea
    • upset stomach associated with these symptoms
  • 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 behaviour 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

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

  • STOP USE AND ASK DOCTOR IF

    • symptoms get worse
    • ringing in 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.

  • DIRECTIONS

    • swallow caplet(s) with water, do not chew 
    • adults and children 12 years and over: 2 caplets every 1/2 to 1 hour as needed
    • do not take more than 8 doses (16 tablets) 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 INFORMATION

    • each caplet contains: calcium 27mg, salicylate 102 mg and sodium 2 mg
    • very low sodium
    • TAMPER EVIDENT: do not use if printed seal under cap is torn or missing
    • store at room temperature, in a dry place
  • INACTIVE INGREDIENTS

    calcium carbonate, colloidal silicon dioxide, D&C red 27 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, sodium starch glycolate

  • PRINCIPAL DISPLAY PANEL

    Compate to Pepto-Bismol® caplets active ingredient*
    NDC 21130-132-28
    Signature care
    Upset Stomach Relief

    BISMUTH SUBSALICYLATE 262 mg

    Relief of::
    indigestion, heartburn, nausea, diarrhea, upset stomach


    40 CAPLETS



    37
  • INGREDIENTS AND APPEARANCE
    SIGNATURE CARE UPSET STOMACH RELIEF 
    bismuth subsalicylate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-132
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE262 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeCAPSULESize16mm
    FlavorImprint Code GDC172
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-132-281 in 1 CARTON10/24/2018
    140 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33510/24/2018
    Labeler - Safeway (009137209)
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