Label: DESINFLAMAX - NAPROXEN SODIUM- naproxen sodium tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 30, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet) Purposes

    Naproxen Sodium 220 mg (naproxen 200mg) (NSAID)* .........Pain reliever/Fever reducer

    *nonsteroidal anti-inflammatory drug

  • Uses

    ■ temporarily relieves minor aches and pains due to:

    ■ headache ■ backache ■ muscular aches

    ■ the common cold ■ toothache ■ menstrual cramps

    ■ minor pain of arthritis ■ temporarily reduces fever

  • Warnings

    Allergy alert:

    Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

    ■ hives ■ asthma (wheezing) ■ skin reddening

    ■ facial swelling ■ shock ■ 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

    ■ side effects occur.

    You may report side effects to FDA at 1-800-FDA-1088.

    ■ 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 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 to12 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 20 mg

    ■ store at 20-25° C (68-77° F). Avoid high humidity and excessive heat above 40° C (104° F)

    ■ read all product information before using

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, FD&C Blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide

  • Questions or comments?

    Call: (619) 600-5632 (Mon-Fri 9AM – 5PM EST) or https://www.opmx.us

  • PRINCIPAL DISPLAY PANEL

    NDC 69729-032-24

    Desinflamax Naproxen Sodium

    220mg

    Arthritis/Artritis

    Backache/Dolor de Espalda

    Muscle and Joint Pain/ Dolor Muscular y de Articulaciones

    24 Caplets

    Naproxen Desinflamax 24 Caplets

  • INGREDIENTS AND APPEARANCE
    DESINFLAMAX - NAPROXEN SODIUM 
    naproxen sodium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69729-032
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN220 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    FD&C BLUE NO. 2 ALUMINUM LAKE (UNII: 4AQJ3LG584)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    Product Characteristics
    Colorblue (Light Blue) Scoreno score
    ShapeOVAL (Capsule-Shaped) Size12mm
    FlavorImprint Code 220
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69729-032-242 in 1 CARTON06/30/2023
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09135306/30/2023
    Labeler - OPMX LLC (029918743)
    Establishment
    NameAddressID/FEIBusiness Operations
    Granules India Limited860316511manufacture(69729-032) , label(69729-032) , pack(69729-032)