trilosprintec norgestimate and ethinyl estradiol kit
1 INDICATIONS AND USAGE Tri-Lo-Sprintec ® (norgestimate and ethinyl estradiol tablets) is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. ( 1.1 ) 1.1 Oral Contraception Tri-Lo-Sprintec ® (norgestimate and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14)] .
teva pharmaceuticals usa, inc.
ROUND GREY B 451
B 451 ROUND GREY
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Tri-Lo-Sprintec ® 28 (
NORGESTIMATE AND ETHINYL ESTRADIOL tablets USP) is packaged in cartons of three blister cards (NDC: 0093-2140-62). Each of the 7 gray tablets contains 0.18 mg of the progestational compound, norgestimate, USP together with 0.025 mg of the estrogenic compound, ethinyl estradiol, USP and available as round, film-coated, biconvex, unscored tablets, debossed with stylized b on one side and 451 on the other side; Each of the 7 light blue tablets contains 0.215 mg of the progestational compound, norgestimate, USP together with 0.025 mg of the estrogenic compound, ethinyl estradiol, USP and available as round, film-coated, biconvex, unscored tablets, debossed with stylized b on one side and 452 on the other side; Each of the 7 blue tablets contains 0.25 mg of the progestational compound, norgestimate, USP together with 0.025 mg of the estrogenic compound, ethinyl estradiol, USP and available as round, film-coated, biconvex, unscored tablets, debossed with stylized b on one side and 453 on the other side. The 7 placebo tablets are white, round, biconvex, unscored, placebo tablets, debossed with stylized b on one side and 208 on the other side. 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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