drospirenone and ethinyl estradiol kit

1 INDICATIONS AND USAGE Drospirenone and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy. Drospirenone and ethinyl estradiol tablets are a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 )

glenmark pharmaceuticals inc., usa

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

3 years ago

ROUND YELLOW E5

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied

DROSPIRENONE AND ETHINYL ESTRADIOL Tablets, USP 3 mg/ 0.03 mg are available in packages of three blister packs (NDC 68462-733-29). The film-coated tablets are round and biconvex, one side is debossed with E5 or E6. Each blister pack contains 28 film-coated tablets in the following order: • 21 round, biconvex, light yellow to yellow, film-coated tablets debossed with “E5” on one side, each containing 3 mg drospirenone, USP and 0.03 mg ethinyl estradiol, USP • 7 round, biconvex, white to off-white, film-coated tablets debossed with “E6” on one side. 16.2 Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

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