Label: QC ANTI DIARRHEAL VANILLA REGULAR FLAVOR- bismuth subsalicylate suspension

  • NDC Code(s): 63868-339-12
  • Packager: QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (per 15 ml)

    Bismuth subsalicylate 262 mg

  • Purposes

    Antidiarrheal/Upset stomach reliever

  • Uses

    Relieves

    • traveler’s diarrhea
    • diarrhea
    • upset stomach due to overindulgence in food and drink
    • heartburn
    • indigestion
    • nausea
    • gas
  • 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 ifyou have

    • an ulcer
    • a bleeding problem
    • bloody or black stool

    Ask a doctor before use if you have

    • fever
    • mucus in the stool

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

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

    When using this producta 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 at 1-800-222-1222.

  • Directions

    • shake well immediately before each use
    • adults and children 12 years of age and older : 30 ml or 2 tablespoonful
    • for accurate dosing, use convenient pre-measured dose cup
    • repeat dose every 1/2 hour to 1 hour as needed
    • do not exceed 8 doses in 24 hours
    • use until diarrhea stops but not more than 2 days
    • children under 12 years: ask a doctor
    • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • Other information

    • each 15mL tablespoon contains:sodium 10 mg
    • each 15mL tablespoon contains:salicylate 130 mg
    • do not use if printed inner seal is broken or missing
    • store at room temperature
  • Inactive ingredients

    caramel, carboxymethylcellulose sodium, microcrystalline cellulose, natural and artificial flavor, potassium sorbate, salicylic acid , simethicone emulsion, sucralose, sucrose, water, xanthan gum

    Questions or comments?

    1-866-467-2748

  • PRINCIPAL DISPLAY PANEL - 355 mL Bottle Label

    NDC 63868-339-12

    Compare to the active ingredient in Kaopectate ®

    Diarrhea Relief

    Bismuth Subsalicylate, 262 mg

    Bismuth Subsalicylate, 262 mg

    Antidiarrheal

    Upset Stomach Reliever

    Effective Diarrhea Relief

    Restores Natural Balance

    1. Vanilla Regular Flavor

    12 FL OZ (355 mL)

    100% SATISFACTION GUARANTEED

    Distributed by: C.D.M.A., Inc.

    43157 W. Nine Mile

    Novi. MI 48376-0995

    www.qualitychoice.com

    Question: 248-449-9300

    *This product is not manufactured or distributed by Chattem Inc., the distributor of Kaopectate ®.

    QC(CDMA) Bismuth Subsalicylate Diarrhea Relief
  • INGREDIENTS AND APPEARANCE
    QC ANTI DIARRHEAL   VANILLA REGULAR FLAVOR
    bismuth subsalicylate suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-339
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE262 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARAMEL (UNII: T9D99G2B1R)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorVANILLA (Regular) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-339-12355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/16/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00804/16/2019
    Labeler - QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) (011920774)
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