FDA Label for Naproxen Sodium
View Indications, Usage & Precautions
Naproxen Sodium Product Label
The following document was submitted to the FDA by the labeler of this product Dr.reddy's Laboratories Limited. 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
- backache
- headache
- the common cold
- muscular aches
- menstrual cramps
- toothache
- temporarily reduces fever
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/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
- ask a doctor
Adults and children 12 years and older | |
Children under 12 years |
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 no. 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, titanium dioxide
Questions?
call 1-888-375-3784
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Caplets
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Tablets
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