Label: ULTRA STRENGTH DIGESTIVE RELIEF- bismuth subsalicylate tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 29, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each caplet)

    Bismuth Subsalicylate 525 mg

  • Purpose

    Upset stomach reliever and anti-diarrheal

  • Uses

    relieves

    ▪
    travelers' diarrhea
    ▪
    diarrhea
    ▪
    upset stomach due to overindulgence in food and drink, including:
    ▪
    heartburn
    ▪
    indigestion
    ▪
    nausea
    ▪
    gas
    ▪
    belching
    ▪
    fullness
  • 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 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 or last more than 2 days
    ▪
    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 at 1-800-222-1222.

  • Directions

    ▪
    swallow with water, do not chew
    ▪
    adults and children 12 years and over: 1 caplet (1 dose) every ½ hour or 2 caplets (2 doses) every hour as needed for diarrhea
    ▪
    1 caplet (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
    ▪
    do not exceed 8 doses (8 caplets) 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 54 mg
    ▪
    salicylate 199 mg
    ▪
    very low sodium
    ▪
    store at room temperature
  • Inactive ingredients

    calcium carbonate, crospovidone, FD&C Red No. 27 Lake, magnesium stearate, microcrystalline cellulose, polysorbate 80, sodium lauryl sulphate.

  • Questions?

    1-866-467-2748

  • PRINCIPAL DISPLAY PANEL - 24 Caplet Carton

    Compare to the active Ingredient in Pepto-Bismosol® Ultra Caplets*

    NDC 0363-1302-02

    Ultra Strength

    Digestive Relief

    Bismuth Subsalicylate
    Upset Stomach Reliever/Antidiarrheal

    5 Symptom Digestive Relief

    •
    Heartburn
    •
    Indigestion
    •
    Nausea
    •
    Upset Stomach
    •
    Diarrhea

    2X CONCENTRATED FORMULA

    24 Caplets

    Ultra Strength Digestive Relief 24 Caplets
  • INGREDIENTS AND APPEARANCE
    ULTRA STRENGTH DIGESTIVE RELIEF 
    bismuth subsalicylate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1302
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE525 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeOVAL (Caplet) Size18mm
    FlavorImprint Code RP130
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-1302-021 in 1 CARTON09/26/2022
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00809/26/2022
    Labeler - WALGREENS CO. (008965063)
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