Label: MIRALAC ANTACID - calcium carbonate tablet 

  • NDC Code(s): 0498-0304-01, 0498-0304-10, 0498-0304-25, 0498-0304-50, view more
    0498-0304-90, 0498-0304-91
  • Packager: North Safety Products
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 07/13

If you are a consumer or patient please visit this version.

  • Active ingredient (in each tablet)

    Calcium carbonate 420 mg

    Close
  • Purpose

    Antacid

    Close
  • Uses

    for the relief of

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

    Enter section text here

    Ask a doctor before use if you have

    • kidney stones
    • calcium restricted diet

    Ask a doctor before use if

    you are presently taking a prescription drug. Antacids may interact with certain prescription drugs

    Stop use and ask a doctor if

    symptoms last for more than 2 weeks

    ask a health professional before use

    Keep this and all other drugs out of the reach of children

    In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

    Close
  • Directions

    take 1 to 2 tablets every 4 hours as symptoms occur or as directed by a doctor.

    Close
  • Other information

    each tablet contains: calcium 168 mg

    sucrose free

    lactose free

    store at room temperature

    Close
  • Inactive ingredients

    magnesium stearate, mint flavor, silicon dioxide, sorbitol, starch

    Close
  • Questions or comments?

    1-800-430-4110

    Close
  • Principal Display Panel

    image of pdpMM1

    Close
  • INGREDIENTS AND APPEARANCE
    MIRALAC ANTACID 
    calcium carbonate tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0498-0304
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CALCIUM CARBONATE (CALCIUM CATION and CARBONATE ION) CALCIUM CARBONATE 420 mg
    Inactive Ingredients
    Ingredient Name Strength
    MAGNESIUM STEARATE  
    SILICON DIOXIDE  
    SORBITOL  
    STARCH, CORN  
    Product Characteristics
    Color white (WHITE) Score 2 pieces
    Shape ROUND Size 11mm
    Flavor MINT (MINT FLAVOR) Imprint Code FR8
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0304-91 5000 in 1 CARTON
    1 NDC:0498-0304-90 2500 in 1 CARTON
    1 NDC:0498-0304-50 250 in 1 CARTON
    1 NDC:0498-0304-25 125 in 1 CARTON
    1 NDC:0498-0304-10 50 in 1 CARTON
    1 NDC:0498-0304-01 2 in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part331 02/22/2013
    Labeler - North Safety Products (019777263)
    Establishment
    Name Address ID/FEI Business Operations
    North Safety Products 019777263 manufacture(0498-0304)
    Establishment
    Name Address ID/FEI Business Operations
    UltraTab Laboratories 151051757 manufacture(0498-0304)
    Close