24 HR Naproxen 375 MG Extended Release Oral Tablet

1 INDICATIONS AND USAGE Naproxen sodium extended-release tablets are indicated for the treatment of: rheumatoid arthritis (RA) osteoarthritis (OA) ankylosing spondylitis (AS) tendinitis, bursitis acute gout primary dysmenorrhea (PD) the relief of mild to moderate pain [see Warnings and Precautions (5) ] . Naproxen sodium extended-release tablets are a nonsteroidal anti-inflammatory drug indicated for the treatment of: rheumatoid arthritis (RA)( 1 ) osteoarthritis (OA)( 1 ) ankylosing spondylitis (AS)( 1 ) tendinitis, bursitis ( 1 ) acute gout ( 1 ) primary dysmenorrhea (PD)( 1 ) the relief of mild to moderate pain ( 1 )

Actavis Pharma, Inc.

FDA Reported Adverse Reactions
`[1] fatigue` `[2] nausea` `[3] dyspnoea` `[4] diarrhoea` `[5] drug ineffective` `[6] dizziness` `[7] pain` `[8] fall` `[9] headache` `[10] asthenia`

4 years ago

ROUND WHITE Andrx 825

16 HOW SUPPLIED/STORAGE AND HANDLING Naproxen sodium extended-release tablets are available as follows: 375 mg: white, unscored, round tablet imprinted with “ Andrx 825 ”, in bottles of 100, NDC 62037-825-01. Each tablet contains 412.5 mg naproxen sodium, USP equivalent to 375 mg naproxen. 500 mg: white, unscored, capsule-shaped tablet imprinted with “ Andrx 826 ”; in bottles of 75, NDC 62037-826-75. Each tablet contains 550 mg naproxen sodium, USP equivalent to 500 mg naproxen. 750 mg: white, unscored, capsule-shaped, film-coated tablets printed with “ A750 ” on one side and plain on the other side, in bottles of 30, NDC 62037-827-30. Each tablet contains 825 mg naproxen sodium, USP equivalent to 750 mg naproxen. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. PHARMACIST: Dispense in a well-closed container.

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