Label: CRANE SAFETY BISMUTH- 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 June 23, 2022

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  • Drug Facts

  • Active ingredient (in each tablet)

    Bismuth Subsalicylate 262 mg

    (each tablet contains 102 mg salicylate)

  • Purpose

    Upset stomach reliever/antidiarrheal

  • Uses

    Temporarily relieves

    • traveler's 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

    • 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 if you are taking any drug for

    • anticoagulation (thinning of the blood)
    • diabetes
    • gout
    • arthritis
  • 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
  • When using this product

    a temporary and harmless darkening of the tongue and/or stool may occur. Stool darkening should not be confused with melena.

  • If pregnant or breast-feeding,

    ask a health professional before use.

  • Keep this and all drugs out of reach of children.

    In case of accidental overdose, contact a physician or poison control center immediately.

  • Directions

    • do not use more than directed
    • chew or crush tablets completely befre swallowing
    • do not swallow tablet whole
    • use until diarrhea stops but not more than 2 days
    • drink plenty of clear fluids to help prevent dehydration, which may accompany diarrhea
    • do not exceed 16 tablets in 24 hours

    Adults and children: (12 years and older) Chew 2 tablets every 1/2 to 1 hour or 4 tablets every hour as needed

    Children under 12 years: Do not give to children under 12 years of age.

  • Other information

    • phenylketonurics: contains phenylalanine 1.1mg per tablet
    • each tablet contains 73mg elemental calcium
    • store at room temperature 59º-86ºF (15º-30ºC)
    • tamper-evident sealed packets
    • do not use any opened or torn packets
  • Inactive ingredients

    acacia gum, aspartame, calcium carbonate, D&C red #27, dextrates, flavoring, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide

  • Questions or comments?

    877.506.4291

  • Crane Safety Bismuth Label

    Chewable

    Bismuth Tabs

    Upset Stomach/Diarrhea Relief

    CRANE Safety®

    Bismuth Subsalicylate 262 MG

    Chew or Crush Tablets Completely Before Swallowing.

    Do Not Swallow Tablets Whole.

    36 Tablets

    Tamper Evident

    C Bismuth

  • INGREDIENTS AND APPEARANCE
    CRANE SAFETY BISMUTH 
    bismuth subsalicylate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73408-406
    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
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    DEXTRATES (UNII: G263MI44RU)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ACACIA (UNII: 5C5403N26O)  
    ASPARTAME (UNII: Z0H242BBR1)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize16mm
    FlavorImprint Code RH;046
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73408-406-206 in 1 BOX01/17/202011/29/2024
    16 in 1 CELLO PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33501/17/202011/29/2024
    Labeler - Crane Safety LLC (080998015)
    Registrant - Unifirst First Aid Corporation (832947092)
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