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Upset Stomach Relief to Go (Breakthrough Products Inc.)

Available Formats

Dosage Form Package Information Links
POWDER 24 POUCH in 1 BOX (51596-004-24) > 1 POWDER in 1 POUCH (51596-004-01) Label Information
POWDER 12 POUCH in 1 BOX (51596-004-12) > 1 POWDER in 1 POUCH (51596-004-01) Label Information
POWDER 5 POUCH in 1 BOX (51596-004-05) > 1 POWDER in 1 POUCH (51596-004-01) Label Information

Complete Upset Stomach Relief to Go Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active ingredient (per powder)

    Bismuth subsalicylate 525mg


  • Purpose

    Upset stomach reliever/antidiarrheal


  • Uses

    Relieves:

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

  • Warnings

    Reye's syndrome

    Children and teenagers who have or are recovering from chickenpox 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.


  • Directions

    adults and children 12 years and over:

    • see instructions in red box 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


  • Other information

    each dose contains salicylate 199mg


  • Inactive ingredients

    citric acid, flavor, glucose, silica, sucralose


  • Questions?

    1-888-998-7436 (Mon-Fri 9AM-5PM MDT)


  • SPL UNCLASSIFIED SECTION

    Do not use if pouch
    is torn or open

    distributed by
    URGENT Rx
    ®
    Breakthrough Products, Inc.

    Denver, CO 80202


  • PRINCIPAL DISPLAY PANEL - 1 Powder Packet

    New!

    NO
    WATER
    REQUIRED

    POUR DIRECTLY IN MOUTH

    URGENT Rx®
    FAST
    POWDERS
    â„¢

    â—€ SEE OPENING INSTRUCTIONS ON BACK PANEL â–¶

    UPSET
    STOMACH

    URGENT Rx®

    RELIEF
    TO-GO
    â„¢

    BISMUTH SUBSALICYLATE/
    UPSET STOMACH RELIEVER & ANTIDIARRHEAL

    cherry

    distributed by UrgentRx
    1 POWDER PACK

    Principal Display Panel - 1 Powder Packet

  • INGREDIENTS AND APPEARANCE
    UPSET STOMACH RELIEF TO GO 
    bismuth subsalicylate powder
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51596-004
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Bismuth subsalicylate (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE) Bismuth subsalicylate 525 mg
    Inactive Ingredients
    Ingredient Name Strength
    anhydrous citric acid (UNII: XF417D3PSL)  
    dextrose (UNII: IY9XDZ35W2)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    sucralose (UNII: 96K6UQ3ZD4)  
    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; Type 0: Not a Combination Product
    2 NDC:51596-004-12 12 in 1 BOX
    2 NDC:51596-004-01 1 in 1 POUCH; Type 0: Not a Combination Product
    3 NDC:51596-004-24 24 in 1 BOX
    3 NDC:51596-004-01 1 in 1 POUCH; Type 0: Not a Combination Product
    4 NDC:51596-004-10 10 in 1 BOX
    4 1 in 1 PACKET; Type 0: Not a Combination Product
    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)