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

  • NDC Code(s): 0363-9608-01, 0363-9608-05, 0363-9608-09, 0363-9608-20, view more
    0363-9608-27, 0363-9608-61
  • Packager: WALGREENS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 23, 2021

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

  • DRUG FACTS

  • ACTIVE INGREDIENT

    Naproxen Sodium 220 mg

    (naproxen 200 mg)(NSAID)*
    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Pain reliever/Fever reducer

  • INDICATIONS & USAGE

    temporarily relieves minor aches and pains due to:

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

    temporarily reduces fever

  • WARNINGS

    Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

    hives
    facial swelling
    asthma (wheezing)
    shock
    skin reddening
    rash
    blisters

    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 had stomach ulcers or bleeding problems
    take blood thinning (anticoagulant) or steroid drug
    take other drugs 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.

  • DO NOT USE

    Do not use

    • if you have ever had an allergic reaction to any other pain reliever/fever reducer
    • right before or after heart surgery
  • ASK DOCTOR

    Ask a doctor before use if

    • the stomach bleeding warning applies to you
    • you have a history of stomach problems, such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
    • you are taking a diuretic
    • you have problems or serious side effects from taking pain relievers or fever reducers
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

    • under a doctor's care for any serious condition
    • taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin
    • taking any other drug
  • WHEN USING

    When using this product

    take with food or milk if stomach upset occurs

  • STOP USE

    Stop use and ask a doctor if

    • you experience any of the following signs of stomach bleeding:

    feel faint

    vomit blood

    have bloody or black stools

    have stomach pain that does not get better

    you have symptoms of heart problems or stroke:

    chest pain

    trouble breathing

    weakness in one part or side of body

    slurred speech

    leg swelling

    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • you have difficulty swallowing
    • it feels like the pill is stuck in your throat
    • redness or swelling is present in the painful area
    • any new symptoms appear
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding,

    ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

  • 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

    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 cablet every 8 to12 hours while symptoms last
    for the first dose, you may take 2 caplets within the first hour
    do not exceed 2 caplets in any 8-to 12-hour period
    do not exceed 3 caplets in a 24-hour period


    Children under 12 years:

    ask a doctor

  • Other information

    Other information

    each caplet contains: sodium 20 mg
    store at 20-25ºC (68-77ºF).

    Avoid high humidity and excessive heat above 40°C (104°F)

  • INACTIVE INGREDIENT

    Colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 lake, Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide.

  • QUESTIONS

    Questions or comments call 1-877-290-4008

  • 24 COUNT 608R

    Naproxen-220mg- walgreens-24s-labelNaproxen-220mg- walgreens-24s-carton

  • 50 COUNT 608R

    Naproxen-220mg- walgreens-50s-labelNaproxen-220mg- walgreens-50s-carton

  • EZ OPEN 100 COUNT 608R

    Naproxen-220mg- walgreens-100s-label

  • 100 COUNT 608RM CRC

    Naproxen-220mg- walgreens-100s-carton

  • 608R 200 CT LABEL

    Naproxen-220mg- walgreens-200s-label

  • 270 CT 608R LABEL

    Naproxen-220mg- walgreens-270s-label

  • 600CT 608R

    Naproxen-220mg- walgreens-600s-label

  • 90 COUNT 608R

    Naproxen-220mg- walgreens-90s-labelNaproxen-220mg- walgreens-90s-carton

  • INGREDIENTS AND APPEARANCE
    ALL DAY PAIN RELIEF 
    naproxen sodium tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9608
    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)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code 144
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-9608-0550 in 1 BOTTLE; Type 0: Not a Combination Product06/30/2019
    2NDC:0363-9608-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/30/2019
    3NDC:0363-9608-20200 in 1 BOTTLE; Type 0: Not a Combination Product06/30/2019
    4NDC:0363-9608-27270 in 1 BOTTLE; Type 0: Not a Combination Product06/30/2019
    5NDC:0363-9608-61600 in 1 BOTTLE; Type 0: Not a Combination Product06/30/2019
    6NDC:0363-9608-091 in 1 CARTON06/26/2021
    690 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09054506/26/2019
    Labeler - WALGREENS (008965063)
    Registrant - TIME CAP LABORATORIES, INC (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LTD925822975manufacture(0363-9608)