Label: ALL DAY PAIN RELIEF- naproxen sodium tablet, coated

  • NDC Code(s): 0363-6099-01, 0363-6099-05, 0363-6099-20
  • Packager: WALGREENS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 14, 2019

If you are a consumer or patient please visit this version.

  • 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 stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide.

  • PURPOSE

    Pain reliever/ fever reducer

  • INDICATIONS & USAGE

    temporarily relieves minor aches and pain due to:

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

    temporarily reduces fever

  • DOSAGE & ADMINISTRATION

    do not take 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 the first dose, you may take 2 tablets within the first hour
    do not exceed 2 tablets in any 8-to 12-hour period
    do not exceed 3 tablets in a 24-hour period


    Children under 12 years:

    ask a doctor

  • 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 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.

    Heart attack and stroke warning: NSAID's, except aspirin, increases the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer 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

    50CT 609R

  • PRINCIPAL DISPLAY PANEL

    100CT 609R

  • PRINCIPAL DISPLAY PANEL

    200CT 609R

  • INGREDIENTS AND APPEARANCE
    ALL DAY PAIN RELIEF 
    naproxen sodium tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-6099
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM220 mg
    Inactive Ingredients
    Ingredient NameStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POVIDONE (UNII: FZ989GH94E)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorblueScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 141
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-6099-0550 in 1 BOTTLE; Type 0: Not a Combination Product07/08/2019
    2NDC:0363-6099-01100 in 1 BOTTLE; Type 0: Not a Combination Product07/08/2019
    3NDC:0363-6099-20200 in 1 BOTTLE; Type 0: Not a Combination Product07/08/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09054506/30/2019
    Labeler - WALGREENS (008965063)
    Registrant - TIME CAP LABORATORIES INC (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LTD925822975manufacture(0363-6099)