Label: NUTRALOX- calcium carbonate tablet, chewable

  • NDC Code(s): 50332-0106-1, 50332-0106-3, 50332-0106-4, 50332-0106-7, view more
    50332-0106-8
  • Packager: HART Health
  • 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 10/12

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  • PURPOSE

    Purpose: Antacid

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  • INDICATIONS & USAGE

    Uses: Temporarily relieves

    • heartburn
    • sour stomach
    • acid indigestion
    • upset stomach
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  • ASK DOCTOR/PHARMACIST

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

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  • WARNINGS

    Warnings:

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  • STOP USE

    Stop use and ask a doctor if symptoms last for more than 2 weeks

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  • PREGNANCY OR BREAST FEEDING

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

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  • DOSAGE & ADMINISTRATION

    Directions: Do not take more than directed

    Adults and children 12 years of age and over:

    • thoroughly chew 2 tablets every 3 to 4 hours as symptoms occur
    • do not take more than 16 tablets in 24 hours unless directed by a doctor
    • do not use the maximum dose for more than 2 weeks

    Childrenunder 12 years of age: ask a doctor

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  • INACTIVE INGREDIENT

    Inactive Ingredients: Corn Starch, Magnesium Stearate, Peppermint Flavor, Sucrose

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  • PRINCIPAL DISPLAY PANEL

    Nutralox.jpg

    Nutralox.jpg

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  • INGREDIENTS AND APPEARANCE
    NUTRALOX 
    calcium carbonate tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50332-0106
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CARBONATE 420 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN  
    MAGNESIUM STEARATE  
    PEPPERMINT  
    SUCROSE  
    Product Characteristics
    Color white Score no score
    Shape ROUND Size 12mm
    Flavor Imprint Code NLX
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50332-0106-3 20 in 1 BOX, UNIT-DOSE
    1 2 in 1 PACKET
    2 NDC:50332-0106-4 50 in 1 BOX, UNIT-DOSE
    2 2 in 1 PACKET
    3 NDC:50332-0106-7 125 in 1 BOX, UNIT-DOSE
    3 2 in 1 PACKET
    4 NDC:50332-0106-8 250 in 1 BOX, UNIT-DOSE
    4 2 in 1 PACKET
    5 NDC:50332-0106-1 500 in 1 BOX, UNIT-DOSE
    5 2 in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part331 01/20/1987
    Labeler - HART Health (069560969)
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