Label: TRIAL ANTACID - calcium carbonate tablet

  • NDC Code(s): 35418-310-02, 35418-310-67, 35418-310-68, 35418-310-69
  • Packager: Zee Medical 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 11/12

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

  • ACTIVE INGREDIENT

    Active Ingredient (in each tablet)  Calcium Carbonate-420 mg

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  • PURPOSE

    Purpose-Antacid

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  • INDICATIONS & USAGE

    Uses relieves:
    ■ heartburn
    ■ acid indigestion
    ■ sour stomach
    ■ upset stomach due to these symptoms

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  • DOSAGE & ADMINISTRATION

    Directions
    ■ chew 2 to 4 tablets. Repeat hourly if symptoms return.
    ■ do not take more than 18 tablets in 24 hours
    ■ do not use the maximum dosage more than 2 weeks Close
  • WARNINGS

    Warnings
    Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interfere
    with certain prescription drugs

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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding baby, ask a health professional  
    before use

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  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. In case of overdose,  
    get medical help or contact a Poison Control Center right away.  
    Prompt medical attention is critical for adults as well as for  
    children even if you do not notice any signs or symptoms.

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  • INACTIVE INGREDIENT

    nactive ingredients
    acacia*, cornstarch*, magnesium stearate, silica*, sorbitol, mint flavor, stearic acid* *contains one or more of these ingredients

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  • PRINCIPAL DISPLAY PANEL

    MM1Trial 250 Box 1

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  • INGREDIENTS AND APPEARANCE
    TRIAL ANTACID 
    calcium carbonate tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:35418-310
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CALCIUM CARBONATE (CARBONATE ION) CALCIUM CARBONATE 420 mg
    Inactive Ingredients
    Ingredient Name Strength
    SORBITOL  
    ACACIA  
    MAGNESIUM STEARATE  
    SILICON DIOXIDE  
    STARCH, CORN  
    STEARIC ACID  
    Product Characteristics
    Color white (snow white) Score no score
    Shape ROUND (ZEE;TL) Size 13mm
    Flavor SPEARMINT (spearmint) Imprint Code ZEE;TL
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:35418-310-69 500 in 1 CARTON
    1 NDC:35418-310-68 50 in 1 CARTON
    1 NDC:35418-310-67 125 in 1 CARTON
    1 NDC:35418-310-02 2 in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part331 06/12/2012
    Labeler - Zee Medical Inc (009645623)
    Registrant - Ultra Seal Corporation (085752004)
    Establishment
    Name Address ID/FEI Business Operations
    Ultratab Laboratories, Inc. 151051757 manufacture(35418-310)
    Establishment
    Name Address ID/FEI Business Operations
    Ultra Seal Corporation 085752004 repack(35418-310)
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