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  5. Label Information: Naproxen Sodium Back And Muscle Pain Caplets

FDA Label for Naproxen Sodium Back And Muscle Pain Caplets

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH TABLET/CAPLET)
    2. PURPOSES
    3. USES
    4. WARNINGS
    5. OTHER
    6. OTC- ASK A DOCTOR SECTION
    7. OTC- DO NOT USE SECTION
    8. OTC - ASK DOCTOR/PHARMACIST SECTION
    9. OTC - WHEN USING SECTION
    10. OTC - PREGNANCY OR BREAST FEEDING SECTION
    11. OTC - STOP USE SECTION
    12. OTC - KEEP OUT OF REACH OF CHILDREN SECTION
    13. DIRECTIONS
    14. OTHER INFORMATION
    15. INACTIVE INGREDIENTS
    16. QUESTIONS OR COMMENTS?
    17. HEADACHE PAIN
    18. BACK AND MUSCLE PAIN

Naproxen Sodium Back And Muscle Pain Caplets Product Label

The following document was submitted to the FDA by the labeler of this product Dr.reddy's Laboratories Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (In Each Tablet/Caplet)



Naproxen sodium USP, 220 mg
(naproxen USP, 200 mg) (NSAID)

nonsteroidal anti-inflammatory drug


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




Other



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 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

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 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.


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


Headache Pain



Headache Pain - Container


Back And Muscle Pain



Back and Muscle Pain- Container


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