NAPROXEN SODIUM TABLET [PRODUCTOS ZAPOTOL CORP.]

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NAPROXEN SODIUM TABLET [PRODUCTOS ZAPOTOL CORP.]
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NDC 59428-168-24
Set ID 863852dc-7edd-4298-ab8a-42a919d6ecbc
Category HUMAN OTC DRUG LABEL
Packager Productos Zapotol Corp.
Generic Name
Product Class
Product Number
Application Number ANDA079096
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  • Active ingredient (in each tablet)

    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
  • 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

    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 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 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 tablet contains: sodium 20 mg
    • store at 20º to 25°C (68º to 77°F). Avoid high humidity and excessive heat above 40°C (104°F).
    • read all warnings and directions before use. Keep carton.
  • Inactive ingredients

    croscarmellose sodium, FD&C blue #2, macrogol, magnesium stearate, polyvinyl alcohol, povidone, pregelatinized starch, talc and titanium dioxide

  • Questions or comments?

    1-888-927-6865

  • Principal Display Panel

    †Compare to the active ingredient in Aleve®

    STRENGTH TO LAST 12 HOURS

    Naproxen Sodium Tablets 220 mg

    Pain reliever / Fever reducer (NSAID)

    FOR TEMPORARY RELIEF OF:

    • The Common Cold
    • Toothache
    • Temporarily Reduces Fever
    • Backache & Muscular Aches
    • Arthritis Pain

    Caplets** (**Capsule-shaped tablets) 220 mg

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    TAMPER EVIDENT: DO NOT USE IF INNER SEAL UNDER BOTTLE CAP PRINTED WITH "SEALED FOR YOUR PROTECTION" IS BROKEN OR MISSING

    †This product is not manufactured or distributed by Bayer Healthcare, LLC, distributor Aleve®.

    Distributed by

    Productos Zapotol Corp.

    Palmdale, CA 93550

    Product of USA

  • Package Label

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

    New Melubryna Naproxen Sodium Tablets

     
  • INGREDIENTS AND APPEARANCE
    NAPROXEN SODIUM 
    naproxen sodium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59428-168
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeCAPSULESize10mm
    FlavorImprint Code I7
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59428-168-241 in 1 BOX05/31/201612/30/2021
    124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07909605/31/201612/30/2021
    Labeler - Productos Zapotol Corp. (186063850)
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