NAPROXEN SODIUM HEADACHE PAIN CAPLETS- naproxen sodium tablet, coated NAPROXEN SODIUM BACK AND MUSCLE PAIN CAPLETS- naproxen sodium tablet, coated

Naproxen Sodium by

Drug Labeling and Warnings

Naproxen Sodium by is a Otc medication manufactured, distributed, or labeled by Dr.Reddy's Laboratories Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • Purposes

    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

    SPL UNCLASSIFIED SECTION

    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.

    SPL UNCLASSIFIED SECTION

    Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding.

    The chance is higher if you:

    are age 60 or olderhave had stomach ulcers or bleeding problems

    take a blood thinning (anticoagulant) or steroid drug

    take other drugs containing prescription or nonprescription NSAID's (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

    SPL UNCLASSIFIED SECTION

    Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, hear failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

    OTC- ASK A DOCTOR SECTION

    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

    OTC- DO NOT USE SECTION

    Do not use 

    if you have ever had an allergic reaction to any other pain reliever/fever reducer

    right before or after heart surgery 

    OTC - ASK DOCTOR/PHARMACIST SECTION

    Ask a doctor or pharmacist before use if you are 

    under a doctor's care for any serious condition

    taking any other drug 

    OTC - WHEN USING SECTION

    When using this product

    take with food or milk if stomach upset occurs

    OTC - PREGNANCY OR BREAST FEEDING SECTION

    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.

    OTC - STOP USE SECTION

    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 

    OTC - KEEP OUT OF REACH OF CHILDREN SECTION

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • 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/caplet every 8 to 12 hours while symptoms last
    • for the first dose you may take 2 tablets/caplets within the first hour
    • do not exceed 2 tablets/caplets in any 8 to 12 hour period
    • do not exceed 3 tablets/caplets in a 24-hour period
    Children under 12 years
    • ask a doctor
  • Other information

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

    FD &C Blue # 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, titanium dioxide

  • Questions or comments?

    call toll-free weekdays 9 AM to 8 PM EST at 1-888-375-3784

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Dr. Reddy’s Laboratories, Inc.

    Princeton, NJ 08540

  • Headache

    Headache Container Label:

    Container

  • Back and Muscle Pain

    Back and Muscle Pain- ContainerContainer

  • INGREDIENTS AND APPEARANCE
    NAPROXEN SODIUM   HEADACHE PAIN CAPLETS
    naproxen sodium tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 43598-059
    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
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    hypromelloses (UNII: 3NXW29V3WO)  
    magnesium stearate (UNII: 70097M6I30)  
    cellulose, microcrystalline (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    povidone (UNII: FZ989GH94E)  
    talc (UNII: 7SEV7J4R1U)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeCAPSULESize12mm
    FlavorImprint Code R;273
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 43598-059-52225 in 1 BOTTLE; Type 0: Not a Combination Product08/05/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07516808/05/2021
    NAPROXEN SODIUM   BACK AND MUSCLE PAIN CAPLETS
    naproxen sodium tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 43598-060
    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
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    hypromelloses (UNII: 3NXW29V3WO)  
    magnesium stearate (UNII: 70097M6I30)  
    cellulose, microcrystalline (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    povidone (UNII: FZ989GH94E)  
    talc (UNII: 7SEV7J4R1U)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeCAPSULESize12mm
    FlavorImprint Code R;273
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 43598-060-52225 in 1 BOTTLE; Type 0: Not a Combination Product08/05/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07516808/05/2021
    Labeler - Dr.Reddy's Laboratories Inc (802315887)
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