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

  • 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 March 28, 2018

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Calcium Carbonate 420 mg

  • Purpose

    Antacid

  • Uses

    relieves

    • acid indigestion
    • sour stomach
    • heartburn
    • 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 19 tablets in 24 hours
    • do not use the maximum dosage for more than 2 weeks except under the advice 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

    If you are pregnant or breast feeding

    ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children

  • 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 59º-86º F (15º-30º 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 Tablets

    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:0924-0286(NDC:47682-088)
    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
    ACACIA (UNII: 5C5403N26O)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SUCROSE (UNII: C151H8M554)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Product Characteristics
    Colorwhite (white) Scoreno score
    ShapeROUND (ROUND) Size12mm
    FlavorMINT (MINT) Imprint Code FR;8
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-0286-0120 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 finalpart33112/30/2008
    Labeler - Acme United Corporation (001180207)
    Registrant - Acme United Corporation (001180207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation045924339relabel(0924-0286) , repack(0924-0286)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation080119599relabel(0924-0286) , repack(0924-0286)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!