Label: PREMIER VALUE DIARRHEA RELIEF VANILLA FLAVOR- bismuth subsalicylate suspension

  • NDC Code(s): 68016-317-12
  • Packager: PHARMACY VALUE ALLIANCE, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 6, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient (per 15 mL)

    Bismuth Subsalicylate 262 mg

  • Purposes

    Anti-diarrheal/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 if you have

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

    Ask a doctor before use if you have

    •
    a sodium-restricted diet
    •
    fever
    •
    mucus in the stool

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

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

    When using this product a 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

    Premier Value®

    NDC 68016-317-12

    COMPARE TO THE ACTIVE INGREDIENT IN KAOPECTATE®

    Diarrhea Relief

    VANILLA

    Regular flavor

    Bismuth Subsalicylate, 262 mg

    •
    Anti-Diarrheal
    •
    Upset Stomach Reliever

    Effective Diarrhea Relief

    Restores Natural Balance

    Contains Salicylates

    12 FL OZ (355 mL)

    Distributed by:

    Pharmacy Value Alliance, LLC

    407 East Lancaster Avenue,

    Wayne, PA 19087

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

    Premier Value Diarrhea Relief Vanilla Flavor
  • INGREDIENTS AND APPEARANCE
    PREMIER VALUE DIARRHEA RELIEF  VANILLA FLAVOR
    bismuth subsalicylate suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-317
    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 (UNII: 92RU3N3Y1O)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorVANILLAImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-317-12355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/23/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00804/23/2019
    Labeler - PHARMACY VALUE ALLIANCE, LLC (101668460)
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