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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-Sprintec ® (norgestimate and ethinyl estradiol tablets) is a combination of norgestimate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1.1 ) Tri-Sprintec ® (norgestimate and ethinyl estradiol tablets) 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-Sprintec ® (norgestimate and ethinyl estradiol tablets) 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-Sprintec ® (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-Sprintec ® (norgestimate and ethinyl estradiol tablets) 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-Sprintec ® (norgestimate and ethinyl estradiol tablets) should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control [see Clinical Studies ( 14 )] .

Teva Pharmaceuticals USA, Inc.


5 years ago ROUND BLUE b 987 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

ROUND BLUE b 987

5 years ago ROUND BLUE b 987 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

b 987 ROUND BLUE

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Tri-Sprintec ® (

NORGESTIMATE AND ETHINYL ESTRADIOL tablets USP) is packaged in cartons of six blister cards (NDC: 0555-9018-58). Each blister card contains 28 tablets in the following order: 7 gray, round, flat-faced, beveled-edge, unscored tablets debossed with stylized b on one side and 985 on the other side contains 0.18 mg norgestimate, USP and 0.035 mg ethinyl estradiol, USP 7 light blue, round, flat-faced, beveled-edge, unscored tablets debossed with stylized b on one side and 986 on the other side contains 0.215 mg norgestimate, USP and 0.035 mg ethinyl estradiol, USP 7 blue, round, flat-faced, beveled-edge, unscored tablets debossed with stylized b on one side and 987 on the other side contains 0.25 mg norgestimate, USP and 0.035 mg ethinyl estradiol, USP 7 white, round, flat-faced, beveled-edge, unscored tablets debossed with stylized b on one side and 143 on the other side contains inert ingredients 16.2 Storage Conditions Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. PROTECT FROM LIGHT. Keep this and all medications out of the reach of children.


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