Label: UPSET STOMACH RELIEF TO GO- bismuth subsalicylate powder

  • NDC Code(s): 51596-004-01, 51596-004-05, 51596-004-10, 51596-004-12, view more
    51596-004-24
  • Packager: Breakthrough Products 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 October 8, 2014

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

  • 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

    ◀ 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 - 1 Powder Packet
  • INGREDIENTS AND APPEARANCE
    UPSET STOMACH RELIEF TO GO 
    bismuth subsalicylate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51596-004
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Bismuth subsalicylate (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE) Bismuth subsalicylate525 mg
    Inactive Ingredients
    Ingredient NameStrength
    anhydrous citric acid (UNII: XF417D3PSL)  
    dextrose (UNII: IY9XDZ35W2)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    sucralose (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51596-004-055 in 1 BOX
    1NDC:51596-004-011 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:51596-004-1212 in 1 BOX
    2NDC:51596-004-011 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:51596-004-2424 in 1 BOX
    3NDC:51596-004-011 in 1 POUCH; Type 0: Not a Combination Product
    4NDC:51596-004-1010 in 1 BOX
    41 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33509/01/2011
    Labeler - Breakthrough Products Inc. (962008251)