Label: QUALITY CHOICE STOMACH RELIEF 528- bismuth subsalicylate liquid

  • NDC Code(s): 83324-021-08
  • Packager: Chain Drug Marketing Association Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 25, 2018

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

View All Sections
  • ACTIVE INGREDIENT(in each 15 mL)

    Bismuth subsalicylate 525 mg

  • 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 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
    • bloody or black stool
    • 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

    • shake well before use
    • mL = milliliter
    • TBSP = tablespoon
    • adults and children 12 years and over: 1 dose (2 TBSP or 15 mL) every 1/2 hour as needed
    • do not exceed 8 doses (120 mL) in 24 hours
    • use until diarrhea stops but not more than 2 days
    • children under 12 years: ask a doctor
    • drink plenty of fluids to help prevent dehydration caused by diarrhea
  • OTHER INFORMATION

    • each 15 mL or 1 TBSP contains:
    • potassium 15 mg
    • salicylate 236 mg
    • sodium 5 mg
    • protect from freezing
    • avoid excessive heat (over 104oF or 40oC)
    • dosage cup provided
  • INACTIVE INGREDIENTS

    benzoic acid, D&C red # 22, D&C red # 28, flavor, hydroxyethyl cellulose, potassium hydroxide, purified water, saccharin sodium, salicylic acid, simethicone, xanthan gum.

  • PRINCIPAL DISPLAY PANEL

    NDC 83324-021-08

    QUALITY CHOICE
    *compare to the active ingredient in Pepto-Bismol ® Ultra
    Ultra Strength
    Stomach Relief

    Upset Stomach Reliever/Anti-diarrheal
    bismuth subsalicylate 525 mg per 15 mL
     Relieves:

    • Diarrhea
    • Heartburn
    • Indigestion
    • Nausea & Upset Stomach

    Original Flavor
    8 FL OZ (236  mL)


    528-qch


  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE STOMACH RELIEF 528 
    bismuth subsalicylate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83324-021
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE525 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    D&C RED NO. 22 (UNII: 1678RKX8RT)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%) (UNII: L605B5892V)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorPINKScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83324-021-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product04/19/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drugpart33504/19/2024
    Labeler - Chain Drug Marketing Association Inc. (011920774)
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!