Label: LEADER STOMACH RELIEF ORIGINAL STRENGTH- bismuth subsalicylate tablet, chewable

  • 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 22, 2021

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  • Active ingredient (in each tablet)

    Bismuth subsalicylate 262 mg

  • Purpose

    Antidiarrheal/upset stomach reliever

    (total salicylate 102 mg per tablet)

  • Uses

    relieves

    ▪
    travelers’ diarrhea
    ▪
    diarrhea
    ▪
    upset stomach due to overindulgence in food and drink, including:
    ▪
    heartburn
    ▪
    indigestion
    ▪
    nausea
    ▪
    gas
    ▪
    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

    ▪
    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 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 right away.

  • Directions

    ▪
    chew or dissolve tablets in mouth
    ▪
    drink plenty of clear fluids to help prevent dehydration caused by diarrhea
    ▪
    adults and children 12 years and older: 2 tablets every ½ to 1 hour, or 4 tablets every hour as needed
    ▪
    do not exceed 16 tablets in 24 hours
    ▪
    use until diarrhea stops but not more than 2 days
    ▪
    children under 12 years: ask a doctor
  • Other information

    ▪
    each tablet contains: salicylate 102 mg
    ▪
    Do not use if individual blister compartments are torn or open
    ▪
    Store at room temperature 59°-86°F
  • Inactive ingredients

    flavor, magnesium stearate, microcrystalline cellulose, red #27 aluminum lake, sorbitol, sucralose

  • Questions?

    1-800-719-9260

  • Principal Display Panel

    LEADER

    NDC 37205-720-65

    Compare to Pepto-Bismol® active ingredient*

    Pink Bismuth

    Chewable Tablets

    Bismuth Subsalicylate 262 mg

    Original Flavor

    Provides Soothing Relief for:

    •
    Indigestion
    •
    Upset Stomach
    •
    Nausea
    •
    Diarrhea
    •
    Heartburn

    SATISFACTION GUARANTEED

    30 CHEWABLE TABLETS

    All Leader® Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.

    Distributed By: Cardinal Health

    Dublin, Ohio 43017

    www.myleader.com

    CIN 2572691

    *This product is not manufactured or distributed by Procter & Gamble Inc., the distributor of PEPTO-BISMOL®.

    Pink Bismuth Chewable Tablets

    Stomach Relief Chewables Carton

  • INGREDIENTS AND APPEARANCE
    LEADER STOMACH RELIEF  ORIGINAL STRENGTH
    bismuth subsalicylate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-720
    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
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeROUNDSize17mm
    FlavorImprint Code L469
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-720-655 in 1 CARTON08/20/2019
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33508/20/2019
    Labeler - Cardinal Health (097537435)
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