Label: PAIN AND FEVER RELIEF- naproxen sodium tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 18, 2021

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

  • Active Ingredient

    Naproxen sodium 220mg
    (naproxen 200mg) (NSAID)*
    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever/Fever reducer

  • Uses:

    temporarily relieves minor aches and pains due to:

    ■ minor pain of arthritis ■ muscular aches
    ■ backache ■ 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 a 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: NSAIDs, except aspirin,
    increase 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.

  • Ask Doctor:

    ■ 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:

    ■ under a doctor's care for any serious condition
    ■ taking any other drug

  • 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 of swelling is present in the painful area
    ■ any new symptoms appear
    You may report side effects to FDA at 1-800-FDA-1088

  • PREGNANCY

    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

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    Adults and children 12 years and over

    ■ take 1 tablet every 8 to 12 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 hr period

    Children under 12 years

    ■ ask a doctor

  • OTHER INFORMATION

    ■ each tablet contains: sodium 20mg
    ■ store at 20 to 250C (68 to 770F). Avoid high
    humidity and excessive heat above 400C (1040F).

  • INACTIVE INGREDIENTS

    Polyvinyl Pyrolidone, Microcrystalline Cellulose, Starch 1500, Sodium Starch Glycolate, Talc, Magnesium Stearate, FD&C Blue #2, Purified Water, Polysorbate 80, Titanium Dioxide, Polyethylene Glycol, Hypromellose

  • QUESTIONS OR COMMENTS?

    Call 1-732-698-5070 Monday through Friday 9AM–5PM EST or www.pioneerlifesciences.com

  • Do not Use:

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

  • When using this product

    ■ take with food or milk if stomach upset occurs

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    PAIN AND FEVER RELIEF 
    naproxen sodium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72090-003
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN220 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorblue ((Light Blue)) Scoreno score
    ShapeOVALSize12mm
    FlavorImprint Code ET;9
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72090-003-01300 in 1 BOTTLE; Type 0: Not a Combination Product05/19/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20761205/19/2021
    Labeler - Pioneer Life Sciences, LLC (014092742)