Label: JUNEL 21 DAY- norethindrone acetate and ethinyl estradiol tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 1, 2024

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  • SPL UNCLASSIFIED SECTION
    Junel® 21 Day - (norethindrone acetate and ethinyl estradiol tablets USP) Junel®1/20 - (Each light yellow tablet contains 1 mg norethindrone acetate, USP and 20 mcg ethinyl estradiol, USP.) Rx ...
  • BOXED WARNING (What is this?)

    WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS

    Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including Junel, are contraindicated in women who are over 35 years of age and smoke (see CONTRAINDICATIONS and WARNINGS).

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  • DESCRIPTION
    Junel® 21 is a progestogen-estrogen combinations. Each light yellow tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1 mg; ethinyl estradiol, USP ...
  • CLINICAL PHARMACOLOGY
    Combination oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical ...
  • INDICATIONS AND USAGE
    Junel21 and Junel Fe 28 are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I ...
  • CONTRAINDICATIONS
    Oral contraceptives are contraindicated in women who currently have the following conditions: • Thrombophlebitis or thromboembolic disorders - • A past history of deep vein thrombophlebitis or ...
  • WARNINGS
    The use of oral contraceptives is associated with increased risks of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, and gallbladder ...
  • PRECAUTIONS
    1. Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted infections. 2. Physical Examination and Follow-Up - It is good ...
  • PATIENT COUNSELING INFORMATION 
    Advise the patient to read the FDA-approved patient labeling (PATIENT PACKAGE INSERT BRIEF SUMMARY and DETAILED PATIENT PACKAGE INSERT). • Counsel patients that cigarette smoking increases the ...
  • ADVERSE REACTIONS
    An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS section): • Thrombophlebitis - • Arterial ...
  • OVERDOSAGE
    Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea, and withdrawal bleeding may occur in ...
  • NON-CONTRACEPTIVE HEALTH BENEFITS
    The following non-contraceptive health benefits related to the use of oral contraceptives are supported by epidemiological studies which largely utilized oral contraceptive formulations containing ...
  • DOSAGE AND ADMINISTRATION
    The tablet dispenser has been designed to make oral contraceptive dosing as easy and as convenient as possible. The tablets are arranged in either three or four rows of seven tablets each, with ...
  • HOW SUPPLIED
    Junel® 1/20 (21 Tablets) (norethindrone acetate 1 mg and ethinyl estradiol 20 mcg tablets, USP) are packaged in cartons of three blister cards. Each card contains 21 light yellow, round ...
  • REFERENCES
    1. Back DJ, Breckenridge AM, Crawford FE, McIver M, Orme ML’E, Rowe PH and Smith E: Kinetics of norethindrone in women II. Single-dose kinetics. Clin Pharmacol Ther 1978; 24:448-453. 2. Hümpel M ...
  • BRIEF SUMMARY PATIENT PACKAGE INSERT
    This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted infections. Oral contraceptives ...
  • DETAILED PATIENT PACKAGE INSERT
    Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more ...
  • Package/Label Display Panel
    NDC 82804-172-21 - 3 Cyclic Tablet Dispensers x 21 Tablets - 21 - DAY - REGIMEN - Junel® 1/20 - (norethindrone acetate and - ethinyl estradiol tablets, USP) Rx only - THIS PRODUCT (LIKE ALL ORAL CONTRACEPTIVES ...
  • INGREDIENTS AND APPEARANCE
    Product Information