vylibra norgestimate 0.25 mg ethinyl estradiol 0.035 mg
1 INDICATIONS AND USAGE VyLibra is estrogen/progestin COCs, indicated for use by women to prevent pregnancy. (1.1) 1.1 Oral Contraceptive VyLibra tablets are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14) ] .
afaxys pharma, llc
ROUND BLUE 22 S
22 S ROUND BLUE
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied VyLibra (
NORGESTIMATE AND ETHINYL ESTRADIOL tablets USP 0.250 mg/0.035 mg) are available in a blister pack. Each blister pack (28 tablets) contains in the following order: 21 dark blue, round, biconvex, coated tablet debossed with “S” on one side and “22” on other side of the tablet contains 0.250 mg norgestimate and 0.035 mg ethinyl estradiol 7 green round, mottled, biconvex, uncoated tablets, debossed with “S” on one side and “24” on other side of the tablet contains inert ingredients The blister packs are available in the following packages: The Blister Packs are packaged in mono cartons Carton of 1 Blister Pack NDC 50102-235-11 Carton of 3 Blister Packs packaged in mono cartons NDC 50102-235-13 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 the reach of children.
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