Ethinyl Estradiol 0.005 MG norethindrone acetate 1 MG Oral Tablet

1 INDICATIONS AND USAGE Norethindrone acetate and ethinyl estradiol tablets are a combination of an estrogen and progestin indicated in a woman with a uterus for: • Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause ( 1.1 ) • Prevention of Postmenopausal Osteoporosis ( 1.2 ) 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause 1.2 Prevention of Postmenopausal Osteoporosis Limitation of Use When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis.

glenmark pharmaceuticals inc., usa

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

3 years ago

ROUND WHITE D6

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL Tablets, USP are available in the following strengths and package sizes:

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL Tablets, USP 0.5 mg/2.5 mcg, are light pink to pink, round, flat-faced, beveled edge, uncoated, tablets debossed with “D5” on one side and plain on the other side. Each tablet contains 0.5 mg norethindrone acetate, USP and 2.5 mcg ethinyl estradiol, USP and are available as: NDC 68462-656-90 Bottle of 90 Tablets NDC 68462-656-29 1 carton containing 3 individual foil pouches. Each pouch contains 1 blister of 28 tablets

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL Tablets, USP 1 mg/5 mcg are white to off-white, round, flat-faced, beveled edge, uncoated tablets debossed with “D6” on one side plain on the other side. Each tablet contains 1 mg norethindrone acetate, USP and 5 mcg ethinyl estradiol, USP and are available as: NDC 68462-657-90 Bottle of 90 Tablets NDC 68462-657-29 1 carton containing 3 individual foil pouches. Each pouch contains 1 blister of 28 tablets 16.2 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]. Keep

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL tablets out of the reach of children.

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