Label: NUTRALOX- calcium carbonate tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 October 30, 2019

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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:

  • 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

  • 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

  • HOW SUPPLIED

    Product: 50090-4612

    NDC: 50090-4612-0 2 TABLET, CHEWABLE in a PACKET / 50 in a BOX, UNIT-DOSE

  • CALCIUM CARBONATE

    Label Image
  • INGREDIENTS AND APPEARANCE
    NUTRALOX 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-4612(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)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code NLX
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-4612-050 in 1 BOX, UNIT-DOSE10/15/2019
    12 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 - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-4612)
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