Label: CAREALL NAPROXEN SODIUM- naproxen sodium tablet

  • NDC Code(s): 51824-109-01
  • Packager: New World Imports, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 23, 2024

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

  • Active ingredients (in each caplet)

    Active ingredient (in each caplet)

    Naproxen sodium 220mg

    (Naproxen 200mg) (NSAID)*

    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever / fever reducer

  • Uses

    Temporarily relieves minor aches and pains due to: minor pain of arthritis, backache, headache, muscular aches, menstrual cramps, toothache, and  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 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 more 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

    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, kidney disease, asthma, or had a stroke

    you are taking a diuretic

    You have problems or serius side effects from taking pain relievers or fever reducers

    When using this product

    When using this product:

    Take with food or milk if stomach upset occurs. 

    Ask a Doctor

    Ask a doctor or pharmacist before use if you are:

    Under a doctor's care for any serious condition

    taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin

    Taking any other drugs

  • 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, or 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

    If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium at 20 weeks or later in pregnancy unless definately 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 immediately (1-800-222-1222).

  • 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

  • Other Information

    Each caplet contains: Sodium 20mg

  • Inactive ingredients

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

  • PRINCIPAL DISPLAY PANEL

    Naproxen Label

  • INGREDIENTS AND APPEARANCE
    CAREALL NAPROXEN SODIUM 
    naproxen sodium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-109
    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)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code 17
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51824-109-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/23/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07909608/23/2024
    Labeler - New World Imports, Inc. (075372276)