Label: CIRCLE K STOMACH- bismuth subsalicylate liquid

  • NDC Code(s): 66715-5755-4
  • Packager: Lil' Drug Store Products, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 29, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 30 mL dose)

    Bismuth subsalicylate 525 mg

  • Purpose

    Upset stomach reliever/Antidiarrheal

  • Uses

    relieves

    • diarrhea
    • travelers' diarrhea
    • upset stomach due to overindulgence in food and drink, including
      • heartburn
      • gas
      • indigestion
      • nausea
      • 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 children. In case of overdose, get medical help or contact a Poison 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 ½ hour or 60 mL (2 doses) every hour as needed for diarrhea/travelers' diarrhea
      • 30 mL (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
      • 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: potassium 8 mg, sodium 6 mg
    • each 30 mL contains: salicylate 206 mg
    • low sodium
    • keep tightly closed
    • protect from freezing
    • avoid excessive heat (over 104°F or 40°C)
  • Inactive ingredients

    benzoic acid, D&C red #22, D&C red #28, flavor, glycerin, purified water, sucralose, xanthan gum

  • Questions?

    Call toll free 1-877-507-6516 (M-F 8AM-4:30PM CST)

  • SPL UNCLASSIFIED SECTION

    Proudly distributed by
    Circle K Stores Inc.

  • PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

    Compare to the Active Ingredient in Pepto-Bismol ®*

    CIRCLE K ®

    Stomach

    Bismuth Subsalicylate 525 mg

    Upset Stomach Reliever/Antidiarrheal

    Relieves

    • Nausea - Heartburn
    • Indigestion
    • Upset Stomach
    • Diarrhea

    8 FL OZ (237mL)

    PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

  • PDP

    RELIEF OF NAUSEA, HEARTBURN,
    INDIGESTION, UPSET STOMACH, DIARRHEA
    Compare to the active ingredient
    in Pepto-Bismol®*

    CIRCLE K™

    soothe
    upset stomach
    Bismuth Subsalicylate 525 mg
    Upset Stomach Reliever/Antidiarrheal

    PDP

  • INGREDIENTS AND APPEARANCE
    CIRCLE K STOMACH 
    bismuth subsalicylate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-5755
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE) 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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-5755-4237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/202007/26/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33510/16/201507/26/2024
    Labeler - Lil' Drug Store Products, Inc (093103646)
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