NAPROXEN SODIUM TABLET [FREDS INC]

NAPROXEN SODIUM TABLET [FREDS INC]
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NDC 55315-991-24, 55315-992-05, 55315-992-10, 55315-992-24
Set ID 54232d88-ed83-04da-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager FREDS INC
Generic Name
Product Class
Product Number
Application Number ANDA091353
  • Active ingredient (in each tablet) Active ingredient (in each caplet)

    Naproxen sodium 220 mg
    (naproxen 200 mg) (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

  • 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

  • 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 high blood pressure, heart disease, liver cirrhosis, or kidney disease
    ■ you are taking a diuretic
    ■ you have problems or serious side effects from taking pain relievers or fever reducers
    ■ you have asthma

  • 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
    ■ the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

  • 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
    ■ 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 the reach of children

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

  • Directions

    for Tablets

    ■ 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 under 12 years
    ■ ask a doctor

    For Caplets

    ■ 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 caplet every 8 to 12 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

    ■ each tablets contains: sodium 20 mg

    ■ store at 20 - 25°C (68° to 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, sodium starch glycolate, stearic acid, titanium dioxide.

  • Questions or comments?

    1-877-770-3183 Mon-Fri 9:00 AM to 4:00 PM EST

  • ALL DAY PAIN RELIEF Naproxen Sodium Tablets, USP 220 mg Pain Reliever/Fever Reducer (NSAID) GLUTEN-FREE STRENGTH TO LAST 12 HOURS 24 Tablets

    24 Count Tablets

  • ALL DAY PAIN RELIEF Naproxen Sodium Tablets, USP 220 mg GLUTEN-FREE Pain Reliever/Fever Reducer (NSAID) STRENGTH TO LAST 12 HOURS 24 Caplets+ + Capsule-Shaped Tablets

    24 Count Caplets

  • ALL DAY PAIN RELIEF Naproxen Sodium Tablets, USP 220 mg GLUTEN-FREE Pain Reliever/Fever Reducer (NSAID) STRENGTH TO LAST 12 HOURS 50 Caplets+ + Capsule-Shaped Tablets

    50 Count Caplets

  • ALL DAY PAIN RELIEF Naproxen Sodium Tablets, USP 220 mg GLUTEN-FREE Pain Reliever/Fever Reducer (NSAID) STRENGTH TO LAST 12 HOURS 100 Caplets+ + Capsule-Shaped Tablets

    100 Count Caplets

  • INGREDIENTS AND APPEARANCE
    NAPROXEN SODIUM 
    naproxen sodium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-992
    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
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code 220
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55315-992-2424 in 1 BOTTLE; Type 0: Not a Combination Product08/17/2017
    2NDC:55315-992-0550 in 1 BOTTLE; Type 0: Not a Combination Product08/17/2017
    3NDC:55315-992-10100 in 1 BOTTLE; Type 0: Not a Combination Product08/17/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09135308/17/2017
    NAPROXEN SODIUM 
    naproxen sodium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-991
    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
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POVIDONE K30 (UNII: U725QWY32X)  
    Product Characteristics
    ColorblueScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code I1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55315-991-2424 in 1 BOTTLE; Type 0: Not a Combination Product08/17/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09135308/17/2017
    Labeler - FREDS INC (005866116)

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