Label: NAPROXEN- naproxen sodium tablet

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

Drug Label Information

Updated January 20, 2020

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Naproxen sodium 220 mg (NSAID)**

  • Purposes

    Pain reliever/fever reducer (naproxen 200 mg) ** nonsteroidal anti-inflammatory drug

  • 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.

    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 a doctor before use if

    • the stomach bleeding warning applies to you
    • you have a history of stomach problems, such as heartburn
    • you have had 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 a doctor or pharmacist before use if you are

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

    When using this product

    • take with food or milk if stomach upset occurs

    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

    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

    • 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 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-hour period
    Children under12 years
    • ask a doctor
  • Other information

    • each tablet contains: sodium 20 mg
    • store at 20 - 25°C (68 - 77°F).

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

  • Inactive ingredients

    FD&C blue#2 aluminum lake, hypromellose, maize starch, microcrystalline cellulose, polyethylene glycol, povidone k-30, sodium starch glycolate, stearic acid, titanium dioxide

  • Questions or comments?

    Call toll free: 1-800-456-7077

  • Principal Display Panel – Pouch Label

    Safetec
    of America, Inc.

    DO NOT USE IF POUCH IS TORN OR DAMAGED

    Manufactured for Safetec of America, Inc.

    Buffalo NY 14215

    Naproxen Sodium Tablets USP, 220 mg (NSAID)**

    Pain reliever/fever reducer

    STRENGTH TO LAST 12 HOURS

    Contains no Ingredient made from a
    gluten-containing grain (wheat, barley, or rye)

    1 Tablet

    Principal Display Panel – Pouch Label
  • Principal Display Panel – 50-Pouch Carton Label

    Safetec®
    of America, Inc.

    Compare to the active ingredient
    in Aleve
    ® Tablets*

    NDC 61010-4410-1

    STRENGTH TO LAST 12 HOURS

    Naproxen Sodium

    Tablets USP, 220 mg (NSAID)**

    Pain Reliever/Fever Reducer

    PUSH TO OPEN

    Dispense through
    opening

    Contains no ingredient made from a gluten-containing
    grain (wheat, barley, or rye)

    • Relieves minor aches and pains
    • Fever reducer
    • Lasts up to 12 hours

    TAMPER EVIDENT UNIT DOSE POUCHES

    DO NOT USE IF POUCH IS TORN OR DAMAGED

    50 Pouches

    1 Tablet per Pouch

    Principal Display Panel – 50-Pouch Carton Label
  • Principal Display Panel – 100-Pouch Carton Label

    Safetec®
    of America, Inc.

    Compare to the active ingredient
    in Aleve
    ® Tablets*

    NDC 61010-4410-2

    STRENGTH TO LAST 12 HOURS

    Naproxen Sodium

    Tablets USP, 220 mg (NSAID)**

    Pain Reliever/Fever Reducer

    Contains no ingredient made from a gluten-containing
    grain (wheat, barley, or rye)

    • Relieves minor aches and pains
    • Fever reducer
    • Lasts up to 12 hours

    PUSH TO OPEN

    Dispense
    through
    opening

    TAMPER EVIDENT UNIT DOSE POUCHES

    DO NOT USE IF POUCH IS TORN OR DAMAGED

    100 Pouches

    1 Tablet per Pouch

    Principal Display Panel – 100-Pouch Carton Label
  • INGREDIENTS AND APPEARANCE
    NAPROXEN 
    naproxen sodium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-4410
    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
    Microcrystalline Cellulose (UNII: OP1R32D61U)  
    Starch, Corn (UNII: O8232NY3SJ)  
    Sodium Starch Glycolate Type A Potato (UNII: 5856J3G2A2)  
    Povidone K30 (UNII: U725QWY32X)  
    Water (UNII: 059QF0KO0R)  
    Stearic acid (UNII: 4ELV7Z65AP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    Product Characteristics
    Colorblue (blue) Scoreno score
    ShapeROUND (ROUND) Size9mm
    FlavorImprint Code 220
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61010-4410-01 in 1 POUCH; Type 0: Not a Combination Product01/20/2020
    2NDC:61010-4410-150 in 1 CARTON01/20/2020
    2NDC:61010-4410-01 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:61010-4410-2100 in 1 CARTON01/20/2020
    3NDC:61010-4410-01 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09135301/20/2020
    Labeler - Safetec of America, Inc. (874965262)