Label: NAPROXEN SODIUM- naproxen sodium tablet, film coated

  • NDC Code(s): 69230-329-01, 69230-329-02, 69230-329-05, 69230-329-10, view more
    69230-329-24, 69230-329-50
  • Packager: Camber Consumer Care Inc
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 23, 2022

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT(S)

    (in each tablet)
    Naproxen sodium USP 220 mg (naproxen 200 mg) (NSAID)*                                                          
    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Pain reliever/ fever reducer
                   


  • USE(S)


    • temporarily relieves minor aches and pains due to:
       • minor pain of arthritis
       • muscular aches
       • backache
       • headache
       • the common cold
       • menstrual cramps 
       • toothache
    • 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
    Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk 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


    • 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, kidney disease, asthma, or had a stroke
    • you are taking a diuretic
    • you have problems or serious side effects from taking pain relievers or fever reducers


  • 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 drug

  • WHEN USING THIS PRODUCT


    • take with food or milk if stomach upset occurs

  • 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
    • 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
    • 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/BREASTFEEDING


    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 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 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
  • OTHER INFORMATION


     each tablet contains: sodium 21 mg
    • Store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).


  • INACTIVE INGREDIENTS


    corn starch, FD&C blue #2, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, talc and titanium dioxide.

  • QUESTIONS OR COMMENTS?

    1-888-588-1418 (Mon - Fri 9AM - 5PM EST)
     
    Do not use if bottle is open or if foil seal imprinted with "SEALED for YOUR PROTECTION" on bottle opening is missing or broken.
     

    Mfg. Lic. No.: 24/MD/TS/2016/F/G


    Distributed by:
    Camber Consumer Care, Inc.
    Piscataway, NJ 08854, USA.

  • PRINCIPAL DISPLAY PANEL


    Naproxen Sodium Round Shape 100's container Label

    naproxensodium-round-100s-cont-label


     
    Naproxen Sodium Round Shape 100's container Carton Label



    naproxensodium-round-100s-cont-carton-label

  • INGREDIENTS AND APPEARANCE
    NAPROXEN SODIUM  
    naproxen sodium tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69230-329
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    Product Characteristics
    ColorblueScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code H;N11
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69230-329-241 in 1 CARTON10/28/2022
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:69230-329-501 in 1 CARTON10/28/2022
    250 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:69230-329-011 in 1 CARTON10/28/2022
    3100 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:69230-329-021 in 1 CARTON10/28/2022
    4200 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:69230-329-05500 in 1 BOTTLE; Type 0: Not a Combination Product10/28/2022
    6NDC:69230-329-101000 in 1 BOTTLE; Type 0: Not a Combination Product10/28/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21106510/28/2022
    Labeler - Camber Consumer Care Inc (079539968)
    Establishment
    NameAddressID/FEIBusiness Operations
    Annora Pharma Private Limited650980746manufacture(69230-329)