Label: STOMACH RELIEF ULTRA- bismuth subsalicylate liquid

  • NDC Code(s): 0536-1287-36
  • Packager: Rugby Laboratories, 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 December 14, 2022

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  • Active ingredient (in each 15 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 ahould 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

    • do not take more than 8 doses (120 mL) in 24 hours
    • use until diarrhea stops but not more than 2 days
    • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
    • 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:
      • 15 mL (1dose) every 1/2 or 30 mL (2 doses) every hour as needed diarrhea/traveler's diarrhea
      • 15 mL (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) 
    • children under 12 years of age: ask a doctor


  • Other information

    • each 15 mL contains: sodium 5 mg
    • each 15 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® Ultra*

    Extra Strength

    Stomach Relief

    Bismuth Subsalicylate 525 mg

    Upset Stomach Reliever/Antidiarrheal

    Relieves:

    • Heartburn
    • Indigestion
    • Nausea

    2x Strength Per Ounce†

    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.

    †vs Original Pepto-Bismol®

    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 Extra Strength Stomach Relief

  • INGREDIENTS AND APPEARANCE
    STOMACH RELIEF  ULTRA
    bismuth subsalicylate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1287
    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 15 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:0536-1287-36237 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 finalpart33503/29/2020
    Labeler - Rugby Laboratories, Inc. (079246066)
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