tri femynor norgestimate and ethinyl estradiol kit
1 INDICATIONS AND USAGE Tri Femynor is estrogen/progestin COCs, indicated for use by women to prevent pregnancy. (1.1) Tri Femynor 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 Femynor should be used for the treatment of acne only if the patient desires an oral contraceptive birth control. (1.2) 1.1 Oral Contraceptive Tri Femynor Tablets are indicated for use by females of reproductive potential to prevent pregnancy [ see Clinical Studies (14) ]. 1.2 Acne Tri Femynor 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 Femynor should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control [ see Clinical Studies (14) ].
amneal pharmaceuticals ny llc
ROUND PINK E1
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Tri Femynor™ (
NORGESTIMATE AND ETHINYL ESTRADIOL tablets, USP) are available in a blister pack (NDC 69238-1607-6): Each blister pack (28 tablets) contains in the following order: 7 light pink, round, biconvex, film-coated tablets debossed with “E1” on one side of the tablet containing 0.18 mg norgestimate, USP and 0.035 mg ethinyl estradiol, USP 7 light red, round, biconvex, film-coated tablets debossed with “E2” on one side of the tablets containing 0.215 mg norgestimate, USP and 0.035 mg ethinyl estradiol, USP 7 red, round, biconvex, film-coated tablets debossed with “E3” on one side of the tablets containing 0.25 mg norgestimate, USP and 0.035 mg ethinyl estradiol, USP 7 white, round, biconvex, film-coated tablets (non-hormonal placebo) debossed with "C2" on one side containing inert ingredients Keep out of reach of children. 16.2 Storage Conditions Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.
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