FDA Label for Naproxen Sodium

Active Ingredient (In Each Tablet)

Naproxen sodium 220 mg
(Naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/ fever reducer

Uses

temporarily relieves minor aches and pain due to:

• •backache
• •muscular aches
• •minor pain of arthritis
• •menstrual cramps
• •headache
• •toothache
• •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 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

• •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 Doctor If

• •you experience any of the following signs of stomach bleeding:
  • •feel faint
  • •vomit blood
  • •have bloody or black stools
  • •have a stomach pain that dose 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
  
  

Otc - Pregnancy Or Breast Feeding

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
take 1 tablet every 8 to12 hours while symptoms last
for first dose you may take 2 tablets with in 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

 


ask a doctor

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Adults and children 12 years and older:
Children under 12 years:

Storage

• •Store at 20-25 ^oC (68-77 ^oF). Avoid high humidity and excessive heat above 40 ⁰C (104 ⁰F)

Other Information

• •each tablet contains: sodium 20 mg
• •If side effects occur, you may report side effects to
  FDA at 1-800-FDA-1088

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 1-800-540-3765

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