NUTRALOX (CALCIUM CARBONATE) TABLET, CHEWABLE [HART HEALTH]

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NUTRALOX (CALCIUM CARBONATE) TABLET, CHEWABLE [HART HEALTH]
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NDC 50332-0106-1, 50332-0106-3, 50332-0106-4, 50332-0106-7, 50332-0106-8
Set ID 263e20ca-1ca6-4f7c-bae5-525a1184b744
Category HUMAN OTC DRUG LABEL
Packager HART Health
Generic Name
Product Class
Product Number
Application Number PART331
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  • ACTIVE INGREDIENT

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

  • PURPOSE

    Purpose: Antacid

  • INDICATIONS & USAGE

    Uses: Temporarily relieves

    • heartburn
    • sour stomach
    • acid indigestion
    • upset stomach
  • WARNINGS

    Warnings:

  • 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.

  • STOP USE

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

  • PREGNANCY OR BREAST FEEDING

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

  • 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. 1-800-222-1222

  • 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

    Children under 12 years of age: ask a doctor

  • INACTIVE INGREDIENT

    Inactive Ingredients: Acacia Gum, Flavor, Magnesium Stearate, Maltodextrin, Silicon Dioxide, Starch, Sucrose

  • PRINCIPAL DISPLAY PANEL

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    5671Nutraloxv19f.jpg

    5671Nutraloxv19f.jpg5671Nutraloxv19f.jpg

  • INGREDIENTS AND APPEARANCE
    NUTRALOX 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50332-0106
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE420 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SUCROSE (UNII: C151H8M554)  
    ACACIA (UNII: 5C5403N26O)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code NLX
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50332-0106-320 in 1 BOX, UNIT-DOSE01/20/1987
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:50332-0106-450 in 1 BOX, UNIT-DOSE01/20/1987
    22 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:50332-0106-7125 in 1 BOX, UNIT-DOSE01/20/1987
    32 in 1 PACKET; Type 0: Not a Combination Product
    4NDC:50332-0106-8250 in 1 BOX, UNIT-DOSE01/20/1987
    42 in 1 PACKET; Type 0: Not a Combination Product
    5NDC:50332-0106-1500 in 1 BOX, UNIT-DOSE01/20/1987
    52 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33101/20/1987
    Labeler - HART Health (069560969)
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