Label: ANTI-DIARRHEAL MAXIMUM STRENGTH- bismuth subsalicylate tablet

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

Drug Label Information

Updated March 27, 2024

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  • Active ingredient (in each caplet)

    Bismuth subsalicylate 525 mg

  • Purpose

    Antidiarrheal

  • Uses

    relieves

    • travelers' diarrhea      
    • diarrhea
  • 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)
    • gout
    • diabetes
    • 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 right away.

  • Directions

    • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
    • swallow with water; do not chew
    • adults and children 12 years and over: 1 caplet every 1/2 hour or 2 caplets every hour as needed
    • do not exceed 8 caplets in 24 hours
    • use until diarrhea stops but not more than 2 days
    • children under 12 years: ask a doctor 
  • Other information

    • each caplet contains: calcium 45 mg, salicylate 206 mg, sodium 3 mg
    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • avoid excessive heat
    • use by expiration date on package
  • Inactive ingredients

    calcium carbonate, corn starch, D&C red #27 aluminum lake, D&C red #30 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, stearic acid

  • Questions or comments?

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  • Principal display panel

    equate™

    NDC 49035-769-08

    Compare to the active ingredient in Pepto® Diarrhea*

    MAXIMUM STRENGTH
    Anti-Diarrheal
    Bismuth Subsalicylate 525 mg
    Anti-Diarrheal
    Relieves Diarrhea

    Actual Size

    525 mg EACH

    24 CAPLETS

    TAMPER EVIDENT: DO NOT
    USE IF IMPRINTED SAFETY SEAL
    UNDER CAP IS BROKEN OR MISSING

    DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716

    *This product is not manufactured or distributed by
    The Procter & Gamble Company, owner of the registered
    trademark Pepto® Diarrhea. 

    50844    ORG121974908

    Equate 44-749

    Equate 44-749

  • INGREDIENTS AND APPEARANCE
    ANTI-DIARRHEAL  MAXIMUM STRENGTH
    bismuth subsalicylate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-769
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE525 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code 44;749
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-769-0824 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00804/06/2020
    Labeler - Wal-Mart Stores Inc (051957769)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(49035-769)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(49035-769)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(49035-769)
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