WATSONPHARMA
IN-5220/S
PHYSICIAN LABELING
Tri-Norinyl ®
(Norethindrone and Ethinyl Estradiol Tablets USP)
Rx only
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
ORAL CONTRACEPTlVE AGENTS
DESCRIPTION
Tri-Norinyl ® provides a continuous oral contraceptive regimen of 7 blue tablets, 9 yellow-green tablets, 5 more blue tablets, and then 7 orange tablets. Each blue tablet contains norethindrone 0.5 mg and ethinyl estradiol 0.035 mg, each yellow-green tablet contains norethindrone 1 mg and ethinyl estradiol 0.035 mg, and each orange tablet contains inert ingredients.
Norethindrone is a potent progestational agent with the chemical name 17-Hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one. Ethinyl estradiol is an estrogen with the chemical name 19-Nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol. Their structural formulae follow.
 
The yellow-green TRI-NORINYL tablets contain the following inactive ingredients: D&C Green No. 5, D&C Yellow No. 10, lactose, magnesium stearate, povidone, and starch.
The blue TRI-NORINYL tablets contain the following inactive ingredients: FD&C Blue No. 1, lactose, magnesium stearate, povidone, and starch.
The inactive orange tablets in the 28-day regimen contain the following inactive ingredients: FD&C Yellow No. 6, lactose, microcrystalline cellulose, and magnesium stearate.
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