Label: FIRST AID SHOT THERAPY HEARTBURN RELIEF- calcium carbonate liquid

  • 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 January 23, 2015

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Calcium carbonate 1250mg

  • Purposes (in each bottle)

    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 6 bottles in 24 hours
    • Do not use the maximum dosage for more than 2 weeks

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • swallow the contents of 1 bottle as symptoms occur, or as directed by a doctor
    • shake well before use
  • Other Information

    • contains 500mg calcium
    • contains 3.84mg sodium
    • store below 86°F (30°C)
    • Keep from freezing
  • Inactive Ingredients

    Benzyl alcohol, citric acid, glycerin, microcrystalline cellulose and caboxymethylcellulose sodium, natural chocolate flavor, natural ginger with other natural flavors, natural peppermint extract, propylene glycol, purified water, sucrose

  • Questions or comments?

    1-877-958-8331 (Monday-Friday 9AM-5PM PST)

  • SPL UNCLASSIFIED SECTION

    Distributed by
    First Aid Shot Therapy®
    Burlingame, CA 94010

  • PRINCIPAL DISPLAY PANEL - 35 mL Bottle Label

    ●
    HEART
    BURN

    FAST
    – LIQUID –
    RELIEF    ®

    FIRST AID
    SHOT THERAPY®

    CHOCOLATE & PEPPERMINT

    FDA
    COMPLIANT

    calcium carbonate
    antacid

    1.18 FL OZ (35mL)

    Principal Display Panel - 35 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    FIRST AID SHOT THERAPY HEARTBURN RELIEF 
    calcium carbonate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57815-051
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Calcium Carbonate (UNII: H0G9379FGK) (Calcium Cation - UNII:2M83C4R6ZB) Calcium Carbonate1250 mg  in 40 mL
    Inactive Ingredients
    Ingredient NameStrength
    Anhydrous Citric Acid (UNII: XF417D3PSL)  
    Benzyl Alcohol (UNII: LKG8494WBH)  
    Cellulose, Microcrystalline (UNII: OP1R32D61U)  
    Glycerin (UNII: PDC6A3C0OX)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Sucrose (UNII: C151H8M554)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHOCOLATE, PEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57815-051-0140 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33103/01/2015
    Labeler - First Aid Beverages, Inc. (078618157)
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