Label: HEARTBURN RELIEF TO GO- calcium carbonate powder

  • Category: HUMAN OTC DRUG LABEL

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 6, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (per powder)

    Calcium carbonate 1000mg

  • Purpose

    Antacid

  • Uses

    Relieves:

    • heartburn
    • sour stomach
    • acid indigestion
    • upset stomach associated with these symptoms
  • Warnings

    Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs.

    When using this product

    • do not take more than 8 powders in 24 hours
    • do not use the maximum dosage for more than 2 weeks.

    Keep out of reach of children.

  • Directions

    • see instructions in red box for opening packet
    • place 1 powder on the tongue and swallow with or without water as symptoms occur, or as directed by a doctor
  • Inactive ingredients

    acacia gum, flavor, maltodextrin, sucralose

  • Questions?

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

  • SPL UNCLASSIFIED SECTION

    Do not use if pouch
    is torn or open
  • SPL UNCLASSIFIED SECTION

    distributed by
    Urgent Rx®
    Breakthrough Products, Inc.
    Denver, CO 80202

  • PRINCIPAL DISPLAY PANEL - 1 Powder Packet

    NO
    WATER
    REQUIRED
    POUR DIRECTLY IN MOUTH

    New!

    URGENT Rx®
    FAST
    POWDERS    ™

    ◀ SEE OPENING INSTRUCTIONS ON BACK PANEL ▶

    HEART
    BURN
    URGENT Rx®
    RELIEF
    TO-GO    ™

    CALCIUM CARBONATE/
    ANTACID

    mixed berry

    distributed by UrgentRx

    1 POWDER PACK

    PRINCIPAL DISPLAY PANEL - 1 Powder Packet
  • INGREDIENTS AND APPEARANCE
    HEARTBURN RELIEF TO GO 
    calcium carbonate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51596-005
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Calcium carbonate (UNII: H0G9379FGK) (carbonate ion - UNII:7UJQ5OPE7D) Calcium carbonate1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    acacia (UNII: 5C5403N26O)  
    maltodextrin (UNII: 7CVR7L4A2D)  
    sucralose (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorBERRY (Mixed berry) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51596-005-1010 in 1 BOX
    11 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:51596-005-055 in 1 BOX
    2NDC:51596-005-011 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:51596-005-1212 in 1 BOX
    3NDC:51596-005-011 in 1 POUCH; Type 0: Not a Combination Product
    4NDC:51596-005-2424 in 1 BOX
    4NDC:51596-005-011 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33109/01/2011
    Labeler - Breakthrough Products Inc. (962008251)
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