sprintec norgestimate and ethinyl estradiol kit
1 INDICATIONS AND USAGE Sprintec ® (norgestimate and ethinyl estradiol tablets) is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. ( 1.1 ) 1.1 Oral Contraceptive 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 WHITE B 143
B 143 ROUND WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Sprintec ® (
NORGESTIMATE AND ETHINYL ESTRADIOL tablets USP) is packaged in cartons of six blister cards. Each card contains 21 blue tablets and 7 white tablets containing inert ingredients. Each blue tablet contains 0.250 mg of the progestational compound, norgestimate, together with 0.035 mg of the estrogenic compound, ethinyl estradiol which are round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and 987 on the other side. Each white tablet contains inert ingredients and are round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and 143 on the other side. NDC: 0555-9016-58 Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. 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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