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

NAPROXEN SODIUM TABLET, FILM COATED [TIME CAP LABORATORIES, INC]
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NDC 49483-608-00, 49483-608-01, 49483-608-05
Set ID ab7b7b8e-923b-4dc1-812c-78e85de1bee1
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, Croscarmellose sodium, fd&c blue#2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide

  • DOSAGE & ADMINISTRATION

    do not more than directed the smallest effective dose should be used

     drink a full glass of water with each dose -

    Adults and children 12 years and older:
    take 1 tablet every 8 to12 hours while symptoms last

    for first dose you may take 2 tablets with in the first hours

    do not exceed 2 tablets in any 8 to 12 hour perioddo not exceed 3 tablets in a 24 hours period

    children under 12 years: ask a doctor

  • INDICATIONS & USAGE

    temporarily relieves minor aches and pain due to: backache headache menstrual cramps minor pain of arthritis muscular aches the common cold ...

    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 ...

    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 olderhave bad stomach ulcers or bleeding problemstake a blood thinning (anticoagulant) or steroid drugtake 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

    608label

  • INGREDIENTS AND APPEARANCE
    NAPROXEN SODIUM 
    naproxen sodium tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-608
    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 GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code 144
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49483-608-006500 in 1 BAG; Type 0: Not a Combination Product03/28/2016
    2NDC:49483-608-0550 in 1 BOTTLE; Type 0: Not a Combination Product03/28/2016
    3NDC:49483-608-01100 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(49483-608)

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