NAPROXEN SODIUM TABLET, FILM COATED [TIME CAP LABORATORIES, INC]

NAPROXEN SODIUM TABLET, FILM COATED [TIME CAP LABORATORIES, INC]
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NDC 49483-609-00, 49483-609-01, 49483-609-05
Set ID 17ecaee0-c1c6-4360-81c1-d6afe50b9b27
Category HUMAN OTC DRUG LABEL
Packager TIME CAP LABORATORIES, INC
Generic Name
Product Class
Product Number
Application Number ANDA090545
  • ACTIVE INGREDIENT

    Naproxen Sodium Tablets, USP
    220 mg (NSAID)*
    *nonsteroidal anti-inflammatory drug

  • INACTIVE INGREDIENT

    Colloidal Silicon Dioxide

    Croscarmellose Sodium

    FD&C Blue #2 Lake

    Hypromellose

    Magnesium Cellulose

    Polyethylene Glycol

    Povidone

    Titanium Dioxide

  • DOSAGE & ADMINISTRATION

    do not take more than directed
    the smallest effective dose should be used
    drink a full glass of water with each dose

  • INDICATIONS & USAGE

    temporarily relieves minor aches and pain due to:

    backache
    headache
    menstrual cramps
    minor pain of arthritis
    muscular aches
    the common cold
    toothache
    temporarily reduces fever

  • PURPOSE

    Pain reliever/ Fever reducer

  • WARNINGS

    Allergy alerts: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
    asthma (wheezing)
    blisters
    facial swelling
    hives
    rash
    shock
    skin reddening
    If an allergic reaction occurs, stop use and seek medical help right away.

    Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

    are age 60 or older
    have bad stomach ulcers or bleeding problems
    take a blood thinning (anticoagulant) or steroid drug
    take other drug containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    have 3 or more alcoholic drinks every day while using this product.
    take more or for a longer time than directed.

  • KEEP OUT OF REACH OF CHILDREN

    In case of overdose, get medical help or contact a poison control center right away.

  • PRINCIPAL DISPLAY PANEL

    609label

  • INGREDIENTS AND APPEARANCE
    NAPROXEN SODIUM 
    naproxen sodium tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-609
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN220 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 141
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49483-609-006500 in 1 BAG; Type 0: Not a Combination Product03/28/2016
    2NDC:49483-609-0550 in 1 BOTTLE; Type 0: Not a Combination Product03/28/2016
    3NDC:49483-609-01100 in 1 BOTTLE; Type 0: Not a Combination Product03/28/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09054503/28/2016
    Labeler - TIME CAP LABORATORIES, INC (037052099)
    Registrant - TIME CAP LABORATORIES, INC (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975manufacture(49483-609)