Label: MIBELAS 24 FE- norethindrone acetate, ethinyl estradiol and ferrous fumarate kit

  • NDC Code(s): 68180-911-73
  • Packager: Lupin Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 20, 2023

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use Mibelas 24 Fe safely and effectively. See full prescribing information for Mibelas 24 Fe. Mibelas™ 24 Fe (norethindrone ...
  • Table of Contents
    Table of Contents
  • 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 ...

    WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS

    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 should not be used by women who are over 35 years of age and smoke [see CONTRAINDICATIONS (4)].

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  • 1 INDICATIONS AND USAGE
    Mibelas™ 24 Fe is indicated for use by females of reproductive age to prevent pregnancy [see CLINICAL STUDIES (14)]. The efficacy of Mibelas 24 Fe in women with a body mass index (BMI) of ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 How to Take Mibelas 24 Fe - To achieve maximum contraceptive effectiveness, Mibelas 24 Fe must be taken exactly as directed. Instruct patients to take one tablet by mouth at the same time ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Mibelas 24 Fe is available in carton (NDC 68180-911-73) containing three pouches, each pouch containing a bllister of 28 tablets (NDC 68180-911-71). Each blister contains 28 tablets in the ...
  • 4 CONTRAINDICATIONS
    Mibelas 24 Fe is 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 ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Thromboembolic Disorders and Other Vascular Problems - Stop Mibelas 24 Fe if an arterial or deep venous thrombotic event (VTE) occurs. Stop Mibelas 24 Fe if there is unexplained loss of ...
  • 6 ADVERSE REACTIONS
    The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: Serious cardiovascular events and stroke[see BOXED WARNING and WARNINGS AND ...
  • 7 DRUG INTERACTIONS
    Consult the labeling of the concurrently-used drug to obtain further information about interactions with COCs or the potential for enzyme alterations. No drug-drug interaction studies were ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - There is little or no increased risk of birth defects in women who inadvertently use COCs during early pregnancy. Epidemiologic studies and meta-analyses have not found an ...
  • 10 OVERDOSAGE
    There have been no reports of serious ill effects from overdose of oral contraceptives, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.
  • 11 DESCRIPTION
    Mibelas 24 Fe provides an oral contraceptive regimen consisting of 24 white to off white active chewable tablets that contain the active ingredients, followed by 4 brown mottled non-hormonal ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - COCs lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - [See WARNINGS AND PRECAUTIONS (5.2, 5.10) and USE IN SPECIFIC POPULATIONS (8.1)].
  • 14 CLINICAL STUDIES
    The data presented in Section 14 are from a clinical trial conducted with a 24-day regimen of norethindrone acetate 1 mg/ethinyl estradiol 0.020 mg tablets. Mibelas 24 Fe is bioequivalent to ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    16.1 How Supplied - Mibelas 24 Fe is available in carton (NDC 68180-911-73) containing three pouches, each pouch containing a blister of 28 tablets (NDC 68180-911-71). Each blister contains 28 ...
  • 17 PATIENT COUNSELING INFORMATION
    See FDA-approved patient labeling (Patient Information) Counsel patients on the following information: Cigarette smoking increases the risk of serious cardiovascular events from COC use, and ...
  • PATIENT PACKAGE INSERT
    FDA-Approved Patient Labeling - Guide for Using Mibelas™ 24 Fe (my-BELL-as twen-TI-for EFF EE) WARNING TO WOMEN WHO SMOKE - Do not use Mibelas 24 Fe if you smoke cigarettes and are over 35 ...
  • PRINCIPAL DISPLAY PANEL
    Mibelas™ 24 Fe (norethindrone acetate and ethinyl estradiol chewable tablets; and ferrous fumarate tablets) 1 mg/0.02 mg; 75 mg - 3 Pouches of 28 tablets in a carton (NDC 68180-911-73). Rx ...
  • INGREDIENTS AND APPEARANCE
    Product Information