7 Ethinyl Estradiol 0.035 MG norgestimate 0.18 MG Oral Tablet 7 Ethinyl Estradiol 0.035 MG norgestimate 0.215 MG Oral Tablet 7 Ethinyl Estradiol 0.035 MG norgestimate 0.25 MG Oral Tablet 7 Inert Ingredients 1 MG Oral Tablet Pack Tr
1 INDICATIONS AND USAGE Tri-Estarylla (norgestimate and ethinyl estrdiol tablets) is a combinations of norgestimate, a progestin, and ethinyl estradiol, and estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1.1 ) Tri-Estarylla is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri-Estarylla should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. ( 1.2 ) 1.1 Oral Contraceptive Tri-Estarylla (norgestimate and ethinyl estradiol) Tablets are indicated for use by females of reproductive potential to prevent pregnancy [see CLINICAL STUDIES ( 14 )] . 1.2 Acne Tri-Estarylla is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri-Estarylla should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control [see CLINICAL STUDIES ( 14 )].
xiromed, llc.
ROUND GREEN SZ J1
SZ J1 ROUND GREEN
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Tri-Estarylla (
NORGESTIMATE AND ETHINYL ESTRADIOL tablets, USP) is available in blisters containing 28 tablets as follows: Each blister card contains 21 active tablets and 7 inactive tablets. 7 white (active) tablets are round, debossed with SZ on one side and T2 on the other side and contains 0.18 mg of norgestimate and 0.035 mg of ethinyl estradiol . 7 light blue (active) tablets are round, debossed with SZ on one side and T3 on the other side and contains 0.215 mg of norgestimate and 0.035 mg of ethinyl estradiol . 7 blue (active) tablets are round, debossed with SZ on one side and T4 on the other side and contains 0.25 mg of norgestimate and 0.035 mg of ethinyl estradiol . 7 green (inert) tablets are round, debossed with SZ on one side and J1 on the other side. NDC 70700-121-85, Carton containing three blister cards. 16.2 Storage Conditions • Store at 20º-25ºC (68º-77ºF); excursions permitted to 15° to 30°C (59° to 86°F). • Protect from light. • Keep out of the reach of children.
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