Label: GUARDIAN PINK-BISMUTH CHERRY- bismuth subsalicylate tablet, chewable

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

Drug Label Information

Updated December 4, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT(in each tablet)

    Bismuth subsalicylate 262 mg
    (total salicylate 102 mg per tablet)

  • PURPOSE

    Upset stomach reliever and anti-diarrheal

  • USE(S)

    relieves:


    • diarrhea
    • heartburn
    • indigestion
    • nausea
    • upset stomach associated with these symptoms
  • 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 behaviour 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 of 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 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 immediately.

  • DIRECTIONS

    • chew or dissolve in mouth
    • adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed
    • do not take more than 8 doses (16 tablets) in 24 hours
    • children under 12 years: ask a doctor
    • drink plenty of fluids to help prevent dehydration caused by diarrhea
  • OTHER INFORMATION

    • each tablet contains:
    • sodium less than 1 mg
    • salicylate 102 mg
    • very low sodium
    • avoid excessive heat (over 104oF or 40oC)
    • TAMPER EVIDENT: Do not use if individual compartments are torn or open
  • INACTIVE INGREDIENTS

    adipic acid, calcium carbonate, D&C red 27 aluminum lake, FD&C red 40 aluminum lake, flavors, magnesium stearate, mannitol, povidone, pregelatinized starch, saccharin sodium

  • PRINCIPAL DISPLAY PANEL

    *Compare to the active ingredient of Pepto-Bismol®
    NDC 53041-022-49
    GAURDIAN®
    Pink-Bismuth Tablets

     

    Cherry Flavor

    Bismuth Subsalicylate
    Anti-diarrheal/Upset Stomach Reliever

    Soothing Relief For:

    • Upset stomach
    • Indigestion
    • Nausea
    • Heartburn
    • Diarrhea

     


    30 CHEWABLE TABLETS



    gdc-122chr
  • INGREDIENTS AND APPEARANCE
    GUARDIAN PINK-BISMUTH CHERRY 
    bismuth subsalicylate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53041-022
    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
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeROUNDSize16mm
    FlavorCHERRYImprint Code GDC122
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53041-022-495 in 1 BOX12/04/2023
    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 Drugpart33512/04/2023
    Labeler - Guardian Drug Company (119210276)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276MANUFACTURE(53041-022)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!