Label: BISMUTH SUBSALICYLATE 262 MG- 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 February 3, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Bismuth subsalicylate 262 mg

  • Purposes

    Anti-diarrheal / Upset stomach reliever

  • Uses

    •
    controls diarrhea
    •
    relieves upset stomach due to overindulgence in food or drink
  • 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.

  • SPL UNCLASSIFIED SECTION

    Allergy alert: Contains salicylates. Do not take if you are:

    •
    allergic to salicylates (including aspirin)
    •
    taking other salicylate products
  • DO NOT USE

    Do not use

    •
    if you have bloody or black stool
    •
    if you have an ulcer or bleeding problem

    Drug Facts continued on back of label

  • ASK DOCTOR

    Ask a doctor before use if you have

    •
    fever
    •
    mucus in the stool
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking any drug for

    •
    anticoagulation (thinning the blood)
    •
    diabetes
    •
    gout
    •
    arthritis
  • WHEN USING

    When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur

  • STOP USE

    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
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    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
    •
    repeat dosage every 1/2 to 1 hour as needed
    •
    do not take more than 8 doses in 24 hours
    •
    use until diarrhea stops but not more than 2 days
    •
    adults and children 12 years and over: 2 tablets
    •
    children under 12 years: ask a doctor
  • Other information

    •
    each tablet contains: calcium 77 mg, salicylate 102 mg
    •
    store at 15°-30°C (59°-86°F)
    •
    protect from moisture
  • Inactive ingredients

    calcium carbonate, D&C red #27 (Al-lake), dextrose, flavor (cherry), magnesium stearate, maltodextrin, silicon dioxide, sorbitol

  • Questions or comments?

    call 516-341-0666, 8:30 am- 4:30 pm ET, Monday-Friday

  • SPL UNCLASSIFIED SECTION

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

  • SPL UNCLASSIFIED SECTION

    *Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Pepto-Bismol®

    Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580

    Relabeled By: Preferred Pharmaceuticals Inc.

    www.reliable1labs.com

  • PRINCIPAL DISPLAY PANEL

    NDC 68788-8128-3

    Bismuth Subsalicylate

    262 mg

    UPSET STOMACH RELIEVER / ANTIDIARRHEAL

    30 CHEWABLE TABLETS

    *compare to Active Ingredients in Pepto-Bismol®

    Bismuth Subsalicylate Tablets 262mg
  • INGREDIENTS AND APPEARANCE
    BISMUTH SUBSALICYLATE 262 MG 
    bismuth subsalicylate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-8128(NDC:69618-029)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE, SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE262 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    CHERRY (UNII: BUC5I9595W)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize16mm
    FlavorCHERRYImprint Code AP;045
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68788-8128-330 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/03/2022
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33502/03/2022
    Labeler - Preferred Pharmaceuticals Inc. (791119022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Preferred Pharmaceuticals Inc.791119022RELABEL(68788-8128)
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