Label: ARANELLE- norethindrone and ethinyl estradiol kit

  • NDC Code(s): 0555-9066-67, 0555-9066-79
  • Packager: Teva Pharmaceuticals USA, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 31, 2023

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  • SPL UNCLASSIFIED SECTION
    Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
  • DESCRIPTION
    Aranelle® 28-Day Regimen (norethindrone and ethinyl estradiol tablets USP) provides a continuous oral contraceptive regimen of 7 light yellow tablets, 9 white tablets, 5 more light yellow ...
  • CLINICAL PHARMACOLOGY
    Combination oral contraceptives act by suppression of gonadotrophins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical ...
  • INDICATIONS AND USAGE
    Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptive products which contain 50 mcg of estrogen ...
  • CONTRAINDICATIONS
    Oral contraceptives should not be used in women who have the following conditions: Thrombophlebitis or thromboembolic disorders - A past history of deep vein thrombophlebitis or thromboembolic ...
  • WARNINGS
    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 cigarettes per day ...
  • PRECAUTIONS
    General - Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases. 1. Physical Examination and Follow-Up - It is ...
  • INFORMATION FOR THE PATIENT
    See PATIENT LABELING printed below.
  • ADVERSE REACTIONS
    Post Marketing Experience - Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs ...
  • 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
    To achieve maximum contraceptive effectiveness, oral contraceptives must be taken exactly as directed and at intervals not exceeding 24 hours. For a DAY 1 START, count the first day of menstrual ...
  • HOW SUPPLIED
    Aranelle® - 28-Day Regimen (norethindrone and ethinyl estradiol tablets USP 0.5/0.035 mg and 1/0.035 mg) – Each blister card contains 12 light yellow, round, flat-faced, beveled-edge, unscored ...
  • REFERENCES
    1. Hatcher, R.A. Trussell, J. Stewart, F., et al.: Contraceptive Technology: Seventeenth Revised Edition, New York, NY, 1998. 2. Mann, J., et al.: Br Med J 2(5956): 241-245, 1975. 3. Knopp, R.H. ...
  • DETAILED PATIENT LABELING
    This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases. INTRODUCTION - Any woman ...
  • 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 diseases. Oral contraceptives, also ...
  • PRINCIPAL DISPLAY PANEL
    NDC 0555-9066-67 - 3 Tablet Dispensers x 28 Tablets - 28 DAY REGIMEN - Arnaelle® (norethindrone and ethinyl estradiol tablets USP) – triphasic regimen - Rx only - THIS PRODUCT (LIKE ALL ORAL ...
  • INGREDIENTS AND APPEARANCE
    Product Information