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DESCRIPTION
ORTHO TRI-CYCLEN ®Tablets
ORTHO-CYCLEN ®Tablets (norgestimate/ethinyl
estradiol) Prescribing Information Patients should be counseled
that this product does not protect against HIV
infection (AIDS) and
other sexually transmitted diseases.
Each of the following products is a combination oral
contraceptive
containing the progestational
compound norgestimate
and the estrogenic
compound ethinyl estradiol.
Each white tablet
contains 0.180 mg of the
progestational
compound, norgestimate (18,19-Dinor-17-pregn-4- en-20-yn-3-one,17-(
acetyloxy)-13-ethyl-, oxime,(17α)-(+)-)
and 0.035 mg of the estrogenic
compound, ethinyl estradiol
(19-nor-17α-pregna,
1,3,5( 10)-trien-20-yne-3,17-diol). Inactive ingredients include
lactose, magnesium stearate, and pregelatinized starch.
Each light blue
tablet contains 0.215
mg of the progestational
compound norgestimate (18,19-Dinor-17-pregn-4- en-20-yn-3-one, 17-(
acetyloxy)-13-ethyl-, oxime,( 17α)-(+)-)
and 0.035 mg of the estrogenic
compound, ethinyl estradiol
(19-nor-17α-pregna,
1,3,5 (10)-trien-20-yne-3,17-diol). Inactive ingredients include
FD&C Blue No.2 Aluminum Lake, lactose, magnesium
stearate, and pregelatinized starch.
Each blue tablet
contains 0.250 mg of the
progestational
compound norgestimate
(18,19-Dinor-17-pregn-4- en-20-yn-3-one, 17-(acetyloxy)-13-ethyl-,
oxime,( 17α)-(+)-)
and 0.035 mg of the estrogenic
compound, ethinyl estradiol
(19-nor-17α-pregna,
1,3,5 (10)-trien-20-yne-3,17-diol). Inactive ingredients include
FD&C Blue No.2 Aluminum Lake, lactose, magnesium
stearate, and pregelatinized starch.
Each green tablet contains only inert
ingredients, as follows: D&C Yellow No.10 Aluminum Lake, FD&C
Blue No.2 Aluminum Lake, lactose, magnesium stearate, microcrystalline
cellulose and pregelatinized
starch.
Each blue tablet
contains 0.250 mg of the
progestational
compound, norgestimate
(18,19-Dinor-17-pregn-4- en-20-yn-3-one,17-(acetyloxy)-13-ethyl-,oxime,(17α)-(+)-)
and 0.035 mg of the estrogenic
compound, ethinyl estradiol
(19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol).
Inactive ingredients include FD&C Blue No.2 Aluminum Lake, lactose,
magnesium stearate, and pregelatinized starch.
Each green tablet contains only inert
ingredients, as follows: D&C Yellow No.10 Aluminum Lake, FD&C
Blue No.2 Aluminum Lake, lactose, magnesium stearate, microcrystalline
cellulose and pregelatinized
starch.
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