Label: CAREALL NAPROXEN- naproxen sodium capsule

  • NDC Code(s): 51824-030-01
  • Packager: New World Imports, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 22, 2018

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

  • Active ingredients (in each tablet)

    Naproxen 200mg

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  • Purpose

    Pain reliever / fever reducer

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  • Uses

    Temporarily relieves minor aches and pains due to: minor pain of arthritis, backache, headache, muscular aches, menstrual cramps, toothache, common cold, temporarily reduces fever

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  • Warnings

    Allergy alert: Naproxen sodium may casue 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 NSAID, which may casue 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 mre alcoholic drinks everyday while using this product, take more or for a longer time than directed.

    Heart attack and stroke warning: NSAIDs, except aspirin, increase the rist 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

    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

    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 of for longer than directed

    Ask a Doctor

    Ask a doctor before use if:

    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 paiin relievers or fever reducers

    You have asthma

    Ask a doctor or pharmacist before use if you are:

    under a doctors care for any serious condition

    Taking any other drug

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  • Stop use and ask a doctor

    Stop use and ask a doctor if:

    You experience any of the following signs of stomach bleeding: you feel faint, vomit blood, have bloddy 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, redness or swelling is present in the painful area, or any new symptoms appear.

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  • If pregnant 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 definately directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery

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  • 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 immediately.

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  • Directions

    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 - 12 hour period
    • Do not exceed 3 caplets in a 24 hour period

    Children under 12 years: ask a doctor

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  • Inactive ingredients

    FD and C blue number 2 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide. May contain: corn starch, croscarmellose sodium, magnesium stearate, purified water, silicon dioxide, sodium starch glycolate, stearic acid

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  • INGREDIENTS AND APPEARANCE
    CAREALL NAPROXEN 
    naproxen sodium capsule
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51824-030
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM 220 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    water (UNII: 059QF0KO0R)  
    starch, corn (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Color blue Score no score
    Shape OVAL Size 12mm
    Flavor Imprint Code 144
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51824-030-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/01/2013
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA090545 05/01/2013
    Labeler - New World Imports, Inc. (075372276)
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