Label: STOMACH RELIEF REGULAR STRENGTH- bismuth subsalicylate liquid

  • NDC Code(s): 0536-1286-36
  • Packager: Rugby Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 22, 2024

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  • Active ingredient (in each 30 mL dose)

    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 (1-800-222-1222) right away.

  • 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 or 60 mL (2 doses) every hour as needed for diarrhea/traveler's diarrhea
      • 30 mL (1 dose) every 1/2 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 9 mg
    • each 30 mL contains: salicylate 206 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, glycerin, purified water, sucralose, xanthan gum

  • Questions or comments?

    Call 1-800-645-2158

  • Principal Display Panel

    Compare to the active ingredient in Pepto-Bismol®*

    Regular Strength

    Stomach Relief

    Bismuth Subsalicylate

    Upset Stomach Reliever/Antidiarrheal

    Relieves:

    • Heartburn • Indigestion • Nausea

    Alcohol Free • Sugar Free

    FL OZ (mL)

    *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:

    RUGBY LABORATORIES

    17177 N Laurel Park Drive

    Suite 233, Livonia, MI 48152

    www.rugbylaboratories.com

  • Package Label

    Bismuth Subsalicylate 525 mg

    RUGBY Regular Strength Stomach Relief

  • INGREDIENTS AND APPEARANCE
    STOMACH RELIEF  REGULAR STRENGTH
    bismuth subsalicylate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1286
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1286-36237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00803/29/2020
    Labeler - Rugby Laboratories, Inc. (079246066)
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