Label: FIRST AID ONLY ANTACID- calcium carbonate tablet, chewable

  • 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 March 29, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Calcium Carbonate 420 mg

  • Purpose

    Antacid

  • Uses

    For the relief of the following symptoms associated with

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

    Ask a doctor or phamacist 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 19 tablets in 24 hours
    • do not use the maximum dosage for more than 2 weeks except under the advise and supervision of a physician
    • do not exceed recommended dosage

    Stop using this product and ask a doctor if

    • symptoms last more than 2 weeks

    Keep out of the reach of children.

    As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

    If you are pregnant or breast feeding,

    ask a health profdessional before use.

  • Directions

    • do not use more than directed

    Adults and children: (12 years and older) Chew 2 tablets every 2 or 3 hours as symptoms occur or as directed by a physician. Do not take more than 19 tablets in 24 hours.

    Children under 12 years: Do not give to children under 12 years of age.

  • Other information

    • Phenylketonurics: contains phenylalanine 1.5 mg per tablet
    • each tablet contains 168 mg of elemental calcium
    • store at room temperature 59-86°F (15-30°C) in a dry place
    • tamper-evident sealed packets
    • do not use any opened or torn packets
  • Inactive ingredients

    aspartame*, croscarmellose sodium*, gum acacia*, magnesium stearate, maltodextrin, mineral oil*, mint flavor, sorbitol*, sucrose*

    *may contain

  • Questions or comments?

    Call 1-800-835-2263

  • PRINCIPAL DISPLAY PANEL

    First Aid Only Antacid Label

    First Aid Only Antacid Label

  • INGREDIENTS AND APPEARANCE
    FIRST AID ONLY ANTACID 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-0287(NDC:47682-201)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE420 mg
    Inactive Ingredients
    Ingredient NameStrength
    ASPARTAME (UNII: Z0H242BBR1)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Colorwhite (white) Scoreno score
    ShapeROUND (ROUND) Size11mm
    FlavorImprint Code AZ;036
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-0287-0120 in 1 BOX, UNIT-DOSE03/28/2018
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33106/15/2014
    Labeler - Acme United Corporation (001180207)
    Registrant - Acme United Corporation (001180207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation045924339relabel(0924-0287) , repack(0924-0287)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation080119599relabel(0924-0287) , repack(0924-0287)
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