Norethindrone and Ethinyl Estradiol and Ferrous Fumarate

Norethindrone and ethinyl estradiol tablets (chewable) and ferrous fumarate tablets (chewable) are indicated for use by females of reproductive potential to prevent pregnancy.

• Norethindrone and ethinyl estradiol tablets (chewable) and ferrous fumarate tablets (chewable) are a progestin/estrogen COC indicated for use by females of reproductive potential to prevent pregnancy. ( 1 )

Norethindrone and ethinyl estradiol tablets (chewable) and ferrous fumarate tablets (chewable) are contraindicated in females who are known to have or develop the following conditions:

• A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:
• Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1) ]
• Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1) ]
• Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1) ]
• Have cerebrovascular disease [see Warnings and Precautions (5.1) ]
• Have coronary artery disease [see Warnings and Precautions (5.1) ]
• Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1) ]
• Have uncontrolled hypertension [see Warnings and Precautions (5.4) ]
• Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.6) ]
• Have headaches with focal neurological symptoms or have migraine headaches with aura [see Warnings and Precautions (5.7) ]
• Women over age 35 with any migraine headaches [see Warnings and Precautions (5.7) ]
• Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions (5.2) ]
• Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.8) ]
• Pregnancy, because there is no reason to use COCs during pregnancy [see Warnings and Precautions (5.9) and Use in Specific Populations (8.1) ]