levonorgestrel and ethinyl estradiol kit

1 INDICATIONS AND USAGE Levonorgestrel and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy. Levonorgestrel and ethinyl estradiol tablets are a combination of levonorgestrel, 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] dyspnoea` `[3] nausea` `[4] diarrhoea` `[5] drug ineffective` `[6] dizziness` `[7] headache` `[8] pain` `[9] off label use` `[10] asthenia`

3 years ago

ROUND WHITE E2

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied

LEVONORGESTREL AND ETHINYL ESTRADIOL Tablets, USP 0.15 mg/0.03 mg are available in Extended-Cycle Tablet Dispensers, each containing a 13-week supply of tablets: • 84 light blue to blue tablets, each containing 0.15 mg of levonorgestrel, USP and 0.03 mg ethinyl estradiol, USP, and 7 white to off-white inert tablets. The active light blue to blue tablets are round, biconvex, film-coated tablets debossed with ' E1 ' on one side and plain on the other. • The inert tablets are white to off-white, round, biconvex, uncoated tablets debossed with ' E2 ' on one side and plain on the other. NDC 68462-672-95 – 1 carton containing 3 foil pouches. Inside each pouch is 1 Extended-Cycle Tablet Dispenser containing 84 light blue to blue tablets and 7 white to off-white tablets. Storage and Handling • 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]. • Protect from light

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