FDA Label for Naproxen Sodium Caplets
View Indications, Usage & Precautions
Naproxen Sodium 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
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 # 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, titanium dioxide
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Package Label.Principal Display Panel Section
Naproxen Sodium Caplets, 220 mg
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