Label: CALCIUM ANTACID- calcium carbonate tablet, chewable

  • NDC Code(s): 62211-219-02, 62211-219-50
  • Packager: A&Z Pharmaceutical, Inc.
  • 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 12/13

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

  • Active ingredient

    Calcium Carbonate 500 mg

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  • Purpose

    Acid Indigestion, Heartburn, Sour & Upset Stomach

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  • Uses

    relieves

    heartburn
    acid
    indigestion
    sour stomach
    upset stomach due to these symptoms
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  • Warnings
  • Ask a doctor or pharmacist before use if you are

    When Using

    do not take more than 15 tablets in a 24 hour period or use the maximum dosage of this product for more than two weeks.

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  • Keep Out of Reach of Children
  • Directions

    chew 2-4 tablets as symptoms occur, repeat hourly if needed

    Other Information

    store at 59°-86°F
    do not use if imprinted safety seal under cap is broken or missing
    Calcium content per tablet: 200mg

    Supplement Facts

    Serving size 2 tablets
    Servings per Container: 25
    Amount Per Serving
    Calories: 5
    Calcium: 400mg(40%DV)
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  • Inactive Ingredients

    Blue #1, dextrose, flavors, magnesium stearate, maltodextrin, red #40, yellow #6, yellow #10

    Manufactured by:

    A&Z Pharmaceutical, Inc.
    Happauge, NY 11788

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  • Package/Label Principal Display Panel

    Sodium Free

    CALCIUM ANTACID

    Regular Strength

    500 mg

    Calcium Supplement

    Fast Relief of Acid Indigestion, Heartburn, Sour & Upset Stomach

    50 Tablets

    Assorted Fruit Chewable Tablets

    Compare to Tums ® Active Ingredient *

    W:\Share\Bashir\Labeling\A2Z Artwork & proofs\Antacid Asst 500 mg 50s\antacid asst 500mg 50s front.jpg
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  • INGREDIENTS AND APPEARANCE
    CALCIUM ANTACID 
    calcium carbonate tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:62211-219
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CARBONATE 500 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C BLUE NO. 1  
    DEXTROSE  
    MAGNESIUM STEARATE  
    MALTODEXTRIN  
    FD&C RED NO. 40  
    FD&C YELLOW NO. 6  
    D&C YELLOW NO. 10  
    Product Characteristics
    Color YELLOW, ORANGE, PINK, GREEN Score no score
    Shape ROUND Size 16mm
    Flavor LIME, CHERRY, ORANGE, LEMON Imprint Code AZ;024
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62211-219-50 50 in 1 BOTTLE
    2 NDC:62211-219-02 150 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part331 12/05/2013
    Labeler - A&Z Pharmaceutical, Inc. (926820705)
    Registrant - A&Z Pharmaceutical, Inc. (926820705)
    Establishment
    Name Address ID/FEI Business Operations
    A&Z Pharmaceutical, Inc. 926820705 MANUFACTURE(62211-219), LABEL(62211-219), PACK(62211-219)
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