colchicine 0.6 mg

1 INDICATIONS AND USAGE Colchicine tablets are an alkaloid indicated for: • Prophylaxis and treatment of gout flares in adults ( 1.1 ). • Familial Mediterranean fever (FMF) in adults and children 4 years or older ( 1.2 ). 1.1 Gout Flares Colchicine tablets are indicated for prophylaxis and the treatment of acute gout flares. • Prophylaxis of Gout Flares: Colchicine tablets are indicated for prophylaxis of gout flares. • Treatment of Gout Flares: Colchicine tablets are indicated for treatment of acute gout flares when taken at the first sign of a flare. 1.2 Familial Mediterranean Fever (FMF) Colchicine tablets are indicated in adults and children four years or older for treatment of familial Mediterranean fever (FMF).

mylan pharmaceuticals inc.

FDA Reported Adverse Reactions
`[1] toxicity to various agents` `[2] completed suicide` `[3] drug ineffective` `[4] drug abuse` `[5] drug interaction` `[6] dyspnoea` `[7] diarrhoea` `[8] nausea` `[9] off label use` `[10] vomiting`

4 years ago

OVAL BROWN M CC 2

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied

COLCHICINE Tablets, USP are available containing 0.6 mg of

COLCHICINE, USP. The 0.6 mg tablets are red, film-coated, oval, scored tablets debossed with M on one side of the tablet and CC to the left of the score and 2 to the right of the score on the other side. They are available as follows: NDC 0378-1086-93 bottles of 30 tablets NDC 0378-1086-01 bottles of 100 tablets 16.2 Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

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colchicine 0.6 mg

mylan pharmaceuticals inc.

colchicine 0.6 mg

mylan pharmaceuticals inc.

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colchicine 0.6 mg

FDA Reported Adverse Reactions [1] toxicity to various agents [2] completed suicide [3] drug ineffective [4] drug abuse [5] drug interaction [6] dyspnoea [7] diarrhoea [8] nausea [9] off label use [10] vomiting

OVAL BROWN M CC 2

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colchicine 0.6 mg

colchicine 0.6 mg

FDA Reported Adverse Reactions
`[1] toxicity to various agents` `[2] completed suicide` `[3] drug ineffective` `[4] drug abuse` `[5] drug interaction` `[6] dyspnoea` `[7] diarrhoea` `[8] nausea` `[9] off label use` `[10] vomiting`