Label: UPSET STOMACH RELIEF TO GO- bismuth subsalicylate powder 

  • NDC Code(s): 51596-004-01, 51596-004-05, 51596-004-12, 51596-004-24
  • Packager: Breakthrough Products Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/13

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (per powder)

    Bismuth subsalicylate 525mg

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  • Purposes

    Upset stomach reliever/antidiarrheal

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  • Uses

    relieves

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

    • anticoagulation (thinning the blood)
    • diabetes
    • gout
    • arthritis

    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 for 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.

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  • Directions

    • adults and children 12 years and over
    • see instructions above for opening packet
    • place 1 powder on the tongue and swallow with or without water every ½ to 1 hour as needed
    • do not exceed 8 doses 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
    • children under 12 years: ask a doctor
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  • Other information

    • each table contains salicylate 242mg
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  • Inactive ingredients

    citric acid, flavor, glucose, silica, sucralose

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  • Questions?

    1-888-99-URGENT (Mon-Fri 9AM-5PM MDT)

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  • SPL UNCLASSIFIED SECTION

    Do not use if pouch
    is torn or open

    distributed by
    URGENT Rx®

    Breakthrough Products, Inc.
    Denver, CO 80202

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  • PRINCIPAL DISPLAY PANEL - Pouch Label

    New!

    RIGHT
    NOW
    RELIEF

    No Liquid Required
    FAST POWDERS
    Pour Directly In Mouth

    SEE OPENING INSTRUCTIONS ON BACK PANEL

    UPSET
    STOMACH

    URGENT Rx®

    RELIEF
    TO-GO

    BISMUTH SUBSALICYLATE / UPSET STOMACH RELIEVER & ANTIDIARRHEAL

    cherry

    distributed by UrgentRx
    1 POWDER PACK

    Principal Display Panel - Pouch Label
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  • INGREDIENTS AND APPEARANCE
    UPSET STOMACH RELIEF TO GO 
    bismuth subsalicylate powder
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:51596-004
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Bismuth subsalicylate (SALICYLIC ACID and BISMUTH CATION) Bismuth subsalicylate 525 mg
    Inactive Ingredients
    Ingredient Name Strength
    anhydrous citric acid  
    dextrose  
    silicon dioxide  
    sucralose  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51596-004-05 5 in 1 BOX
    1 NDC:51596-004-01 1 in 1 POUCH
    2 NDC:51596-004-12 12 in 1 BOX
    2 NDC:51596-004-01 1 in 1 POUCH
    3 NDC:51596-004-24 24 in 1 BOX
    3 NDC:51596-004-01 1 in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part335 09/01/2011
    Labeler - Breakthrough Products Inc. (962008251)
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