Label: STOMACH RELIEF- bismuth subsalicylate tablet

  • NDC Code(s): 49348-511-59
  • Packager: Strategic Sourcing Services LLC
  • 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 6, 2022

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  • Active ingredient (in each caplet)

    Bismuth subsalicylate 262 mg

  • Purpose

    Upset stomach reliever and anti-diarrheal

  • KEEP OUT OF REACH OF CHILDREN

  • Uses

    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 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

    • 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 a 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 immediately.

  • 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 caplets) in 24 hours
    • use until diarrhea stops but not more than 2 days
    • children under 12 years: ask a doctor
    • drink plenty of fluids to help prevent dehydration which may accompany diarrhea.
  • Other information

    • each caplet contains: calcium 27 mg, 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

    sunmark

    COMPARE TO PEPTO-BISMOL® ACTIVE INGREDIENT

    NDC # 49348-511-59

    stomach relief

    Soothing relief for upset stomach, indigestion, nausea, heartburn and diarrhea

    ORIGINAL FORMULA

    40 CAPLETS

    image description

  • INGREDIENTS AND APPEARANCE
    STOMACH RELIEF 
    bismuth subsalicylate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-511
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE262 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MANNITOL (UNII: 3OWL53L36A)  
    Product Characteristics
    ColorpinkScoreno score
    ShapecapsuleSize16mm
    FlavorImprint Code G172
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49348-511-591 in 1 CARTON09/27/2019
    140 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33509/27/2019
    Labeler - Strategic Sourcing Services LLC (116956644)
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