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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 26, 2024

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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 DrugM00106/15/2014
    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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