NAPROXEN SODIUM TABLET [ADVANCED FIRST AID, INC.]

NAPROXEN SODIUM TABLET [ADVANCED FIRST AID, INC.]
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NDC 67060-000-68
Set ID 344f908c-934e-4c98-aeef-68fd09d47c72
Category HUMAN OTC DRUG LABEL
Packager ADVANCED FIRST AID, INC.
Generic Name
Product Class
Product Number
Application Number ANDA090545
  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT IN EACH TABLET-

    Naproxen 200 mg

    (naproxen 200 mg)(NSAID)*

    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    pain reliever/fever reducer

  • INDICATIONS & USAGE

    Uses: temporarily relieves minor aches and pains due to: • minor pain of arthritis • muscular aches • backache • menstrual cramps • headaches • toothache • temporarily reduces fever

  • WARNINGS

    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

    Stomach Bleeding Warning: This product contains 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 for 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 specifically 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.

  • DOSAGE & ADMINISTRATION

    Directions: • do not use more than directed • the smallest effective dose should be used • drink a full glass of water with each dose

    Adults and children 12 years of age and older:  • Take 1 tablet every 8 - 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.

  • INACTIVE INGREDIENT

    Inactive Ingredients: FD&C blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, propylene glycol, povidone, talc, titanium dioxide

  • PRINCIPAL DISPLAY PANEL

    ADVANCED NAPROXEN

  • INGREDIENTS AND APPEARANCE
    NAPROXEN SODIUM 
    naproxen sodium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67060-000
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN200 
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POVIDONE (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 141
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67060-000-6850 in 1 CARTON04/09/2015
    11 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09054504/09/2015
    Labeler - ADVANCED FIRST AID, INC. (114477180)
    Registrant - ADVANCED FIRST AID, INC. (114477180)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULTRA SEAL CORPORATION085752004pack(67060-000)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975manufacture(67060-000)

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