triestarylla norgestimate and ethinyl estradiol kit

1 INDICATIONS AND USAGE Tri-Estarylla™ (norgestimate and ethinyl estradiol tablets),is an estrogen/progestin COCs, indicated for use by women to prevent pregnancy. ( 1.1 ) Tri-Estarylla™ is also 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) is 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 )].

sandoz inc

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

6 years ago

ROUND GREEN SZ J1

6 years ago

SZ J1 ROUND GREEN

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Tri-Estarylla TM (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 0781-4060-15, one box containing 3 individual unit cartons 16.2 Storage Conditions • Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. • Protect from light. Keep out of reach of children

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xiromed, llc.

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