diclofenac sodium 75 mg

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation ). Diclofenac sodium delayed-release tablets are indicated: • for relief of the signs and symptoms of osteoarthritis • for relief of the signs and symptoms of rheumatoid arthritis • for acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis

advagen pharma ltd

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] fatigue` `[3] off label use` `[4] pain` `[5] nausea` `[6] diarrhoea` `[7] headache` `[8] vomiting` `[9] rash` `[10] dyspnoea`

4 weeks ago

ROUND BROWN A12

4 weeks ago

A12 ROUND BROWN

HOW SUPPLIED

DICLOFENAC SODIUM delayed-release tablets, USP are supplied as follows: 25 mg: round, light brown to brown, enteric-coated tablets, imprinted with ‘Λ10’ in black ink on one side and plain on other side. Bottles of 30 tablets NDC 72888-109-30 Bottles of 60 tablets NDC 72888-109-60 Bottles of 100 tablets NDC 72888-109-01 Bottles of 500 tablets NDC 72888-109-05 Bottles of 1000 tablets NDC 72888-109-00 50 mg: round, light brown to brown, enteric-coated tablets, imprinted with ‘Λ11’ in black ink on one side and plain on other side. Bottles of 30 tablets NDC 72888-110-30 Bottles of 60 tablets NDC 72888-110-60 Bottles of 100 tablets NDC 72888-110-01 Bottles of 500 tablets NDC 72888-110-05 Bottles of 1000 tablets NDC 72888-110-00 75 mg: round, light brown to brown, enteric-coated tablets, imprinted with ‘Λ12’ in black ink on one side and plain on other side. Bottles of 30 tablets NDC 72888-111-30 Bottles of 60 tablets NDC 72888-111-60 Bottles of 100 tablets NDC 72888-111-01 Bottles of 500 tablets NDC 72888-111-05 Bottles of 1000 tablets NDC 72888-111-00 Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Dispense in tight container(USP). Protect from moisture. Dispense with Medication Guide available at: www.advagenpharma.com/medguide/diclofenacsodiumdelayedreleasetablets Distributed By: Advagen Pharma Ltd., 666 plainsboro Road, Suite 605, plainsboro, NJ 08536, USA. Manufactured by: Rubicon Research Private Limited Ambernath, Dist: Thane, 421506 India. Rev. 01, 08/2023

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