Label: STOMACH LIL DRUG STORE PRODUCTS- bismuth subsalicylate liquid

  • NDC Code(s): 66715-6855-4
  • Packager: Lil' Drug Store Products, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 15, 2023

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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)

  • PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

    QUALITY
    GUARANTEED

    Compare to the Active
    Ingredient in Pepto-Bismol ®*

    Stomach

    Bismuth Subsalicylate 525 mg
    Upset Stomach Reliever/Antidiarrheal

    Relieves
    • Nausea • Heartburn • Indigestion
    • Upset Stomach • Diarrhea

    8 FL OZ
    (237 mL)

    Lil'
    Drug Store ®

    PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    STOMACH  LIL DRUG STORE PRODUCTS
    bismuth subsalicylate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-6855
    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:66715-6855-4237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00112/01/2014
    Labeler - Lil' Drug Store Products, Inc (093103646)
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