Label: FIRST AID SHOT THERAPY UPSET STOMACH RELIEF- calcium carbonate solution

  • 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 January 17, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (in each bottle)

    Calcium carbonate 1250mg

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

    Keep out of reach of children.

  • Directions

    • swallow 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 carboxymethylcellulose sodium, natural ginger with other natural flavors extract, natural peppermint extract, natural and artificial flavors, propylene glycol, purified water, sorbitol

  • Questions?

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

  • SPL UNCLASSIFIED SECTION

    Distributed by
    First Aid Shot Therapy®
    Burlingame, CA 94010

  • PRINCIPAL DISPLAY PANEL - 34 mL Bottle Label

    F.A.S.T.
    RELIEF

    FIRST AID
    SHOT THERAPY®

    UPSET
    STOMACH
    relief

    calcium carbonate/antacid
    1250mg

    FDA
    COMPLIANT

    Natural Peppermint & Ginger Flavor

    1.15 FL OZ (34mL)

    Principal Display Panel - 34 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    FIRST AID SHOT THERAPY UPSET STOMACH RELIEF 
    calcium carbonate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57815-021
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Calcium Carbonate (UNII: H0G9379FGK) (Carbonate ion - UNII:7UJQ5OPE7D) Calcium Carbonate1250 mg  in 34 mL
    Inactive Ingredients
    Ingredient NameStrength
    Benzyl Alcohol (UNII: LKG8494WBH)  
    Anhydrous Citric Acid (UNII: XF417D3PSL)  
    Glycerin (UNII: PDC6A3C0OX)  
    Cellulose, Microcrystalline (UNII: OP1R32D61U)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Water (UNII: 059QF0KO0R)  
    Sorbitol (UNII: 506T60A25R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorPEPPERMINT (Natural peppermint and ginger flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57815-021-1112 in 1 CARTON
    1NDC:57815-021-0134 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33111/01/2013
    Labeler - First Aid Beverages, Inc. (078618157)
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