STOMACH RELIEF REGULAR STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]

  • Home
  • STOMACH RELIEF REGULAR STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]

STOMACH RELIEF REGULAR STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]
PDF | XML
NDC 36800-625-08, 36800-625-16
Set ID b308c0d3-a0ab-4934-8e7f-a093baea1d27
Category HUMAN OTC DRUG LABEL
Packager TOP CARE (Topco Associates LLC)
Generic Name
Product Class
Product Number
Application Number PART335
View All Sections
  • Active ingredient (in each 30 mL)

    Bismuth subsalicylate 525 mg

  • Purpose

    Upset stomach reliever/Antidiarrheal

  • Uses

    relieves

    • travelers' diarrhea
    • diarrhea
    • upset stomach due to overindulgence in food and drink, including:
      • heartburn
      • indigestion
      • nausea
      • gas
      • fullness
      • belching
  • 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

    • 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 or last more than 2 days
    • 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 childen.

    In case of overdose, get medical help or contact a Posion Control Center right away. (1-800-222-1222)

  • Directions

    • mL = milliliter
    • shake well before using
    • measure only with dosing cup provided. Do not use any other dosing device.
    • keep dosing cup with product
    • adults and children 12 years and over
      • 30 mL (1 dose) every 1/2 to 1 hour as needed
      • do not exceed 8 doses (240 mL) in 24 hours
      • use until diarrhea stops but not more than 2 days
    • children under 12 years of age: ask a doctor
    • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • Other information

    • each 30 mL contains: sodium 10 mg
    • each 30 mL contains: salicylate 248 mg
    • low sodium
    • keep tightly closed
    • protect from freezing
    • avoid excessive heat (over 104ºF or 40ºC)
  • Inactive ingredients

    benzoic acid, D&C red #22, D&C red #28, flavor, magnesium aluminum silicate, methylcellulose, purified water, saccharin sodium, salicylic acid, sodium salicylate, sorbic acid, sucralose

  • Questions or comments?

    Call toll free 1-888-423-0139

  • Principal Display Panel

    COMPARE TO PEPTO-BISMOL® ACTIVE INGREDIENT* 

    REGULAR STRENGTH

    Stomach Relief  

    BISMUTH SUBSALICYLATE 525 mg

    UPSET STOMACH RELIEVER/ANTIDIARRHEAL

    5 SYMPTOM DIGESTIVE RELIEF

    • Heartburn
    • Indigestion
    • nausea
    • Upset Stomach
    • diarrhea

    FL OZ (mL)

    CHERRY FLAVOR

    SUGAR-FREE

    ALCOHOL-FREE

    *This product is not manufactured or distributed by The Procter & Gamble Company. Pepto-Bismol® is a registered trademark of The Procter & Gamble Company.

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.

    DISTRIBUTED BY:TOPCO ASSOCIATES LLC

    ELK GROVE VILLAGE, IL 60007

    topcare@topco.com

  • Package Label

    Bismuth Subsalicylate 525 mg

    TOPCARE HEALTH Regular Strength Stomach Relief

  • INGREDIENTS AND APPEARANCE
    STOMACH RELIEF  REGULAR STRENGTH
    bismuth subsalicylate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-625
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE, SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE525 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    D&C RED NO. 22 (UNII: 1678RKX8RT)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    SODIUM SALICYLATE (UNII: WIQ1H85SYP)  
    SORBIC ACID (UNII: X045WJ989B)  
    METHYLCELLULOSE (1500 CPS) (UNII: P0NTE48364)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-625-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/31/2019
    2NDC:36800-625-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/31/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33503/31/2019
    Labeler - TOP CARE (Topco Associates LLC) (006935977)
View All Sections

Related Drugs

Search DailyMed Drugs