Who is the manufacturer of junel

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Sign up to receive email communication from Teva when new cost-saving Teva generics become available and other health information. We will not share your email or personal information. If you start taking Junel Fe 24 and you have not used a hormonal birth control method before:.

If you start taking Junel Fe 24 and you are switching from another birth control pill:. If you start taking Junel Fe 24 and previously used a vaginal ring or transdermal patch:.

If you start taking Junel Fe 24 and you are switching from a progestin-only method such as an implant or injection:. Follow these instructions for either a Sunday Start or a Day 1 Start. You will use a Sunday Start if your healthcare provider told you to take your first pill on a Sunday. You will use a Day 1 Start if your doctor told you to take your first pill Day 1 on the first day of your period.

The Junel Fe 24 pill pack has 24 "active" light yellow pills with hormones to be taken for 24 days, followed by 4 "reminder" brown pills without hormones to be taken for the next 4 days. If you miss 1 light yellow pill in Weeks 1, 2, or 3, follow these steps:. If you miss 2 light yellow pills in a row in Week 1 or Week 2 of your pack, follow these steps:. If you miss 2 light yellow pills in a row in Week 3 or Week 4, or you miss 3 or more light yellow pills in a row at any time, follow these steps:.

You do not need to use a back-up method of birth control. If you have any questions or are unsure about the information in this leaflet, call your healthcare provider. Food and Drug Administration. DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use.

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Approval: Junel Fe 24 is contraindicated in women over 35 years old who smoke. The ferrous fumarate tablets do not serve any therapeutic purpose.

Stop at least 4 weeks before through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding. Consider an alternative contraceptive method for women with uncontrolled dyslipidemia. Counsel patients to use a back-up method or alternative method of contraception when enzyme inducers are used with COCs. Junel Fe 24 can decrease milk production. Junel Fe 24 inactive tablets are brown Day 25 to Day Day 1 Start: Take first light yellow active tablet without regard to meals on the first day of menses.

Take subsequent active tablets once daily at the same time each day for a total of 24 days. Take one brown inactive tablet daily for 4 days and at the same time of day that active tablets were taken.

Begin each subsequent pack on the same day of the week as the first cycle pack i. Sunday Start: For each day course, take in the following order: Take the light yellow active tablet without regard to meals on the first Sunday after the onset of menses.

Take one brown tablet ferrous fumarate daily for the following 4 days and at the same time of day that active tablets were taken. A scheduled period should occur during the 4 days that the brown tablets are taken. Switching to Junel Fe 24 from another oral contraceptive Start on the same day that a new pack of the previous oral contraceptive would have started. Switching from another contraceptive method to Junel Fe 24 Start Junel Fe Transdermal patch On the day when next application would have been scheduled.

Implant On the day of removal Complete instructions on proper tablet usage are located in the FDA-approved patient labeling. If two consecutive active tablets are missed in Week 1 or Week 2 Take the two missed tablets as soon as possible and the next two active tablets the next day. If two consecutive active tablets are missed in Week 3 or Week 4 or three or more consecutive active tablets are missed at any time Day 1 Start : Throw out the rest of the pack and start a new pack that same day.

Each blister pack 28 tablets contains in the following order: 24 light yellow, round, flat-faced, beveled-edge, unscored active tablets debossed with stylized b on one side and on the other side and each containing 1 mg norethindrone acetate and 0. Do not prescribe Junel Fe 24 to women who are known to have 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.

Stop Junel Fe 24 if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately [see Adverse Reactions 6. If feasible, stop Junel Fe 24 at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE as well as during the following prolonged immobilization.

Start Junel Fe 24 no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum VTE decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.

The risk of VTE is highest during the first year of use of a COCs and when restarting oral contraception after a break of 4 weeks or longer. Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events.

COCs have been shown to increase both the relative and attributable risks of cerebrovascular events thrombotic and hemorrhagic strokes. This risk increases with age, particularly in women over 35 years of age who smoke. Use COCs with caution in women with cardiovascular disease risk factors. 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 Precautions 5.

Endocrine disorders: hypothyroidism, hyperthyroidism. Infections: vaginal infection. Musculoskeletal and connective tissue disorders: myalgia. Women who do not breastfeed should not start COCs earlier than 4 weeks postpartum. Each light yellow tablet contains 1 mg norethindrone acetate, USP and 0. Each brown tablet contains ferrous fumarate, crospovidone, hydrogenated vegetable oil and microcrystalline cellulose.

Ferrous fumarate tablets are not USP for dissolution and assay. Metabolism Norethindrone undergoes extensive biotransformation, primarily via reduction, followed by sulfate and glucuronide conjugation. Excretion Norethindrone and ethinyl estradiol are excreted in both urine and feces, primarily as metabolites.

NDC Cartons of 3 blister cards dispensers Each blister card contains in the following order: 24 light yellow, round, flat-faced, beveled-edge, unscored active tablets debossed with stylized b on one side and on the other side and each containing 1 mg norethindrone acetate, USP and 0.

Protect from light. Counsel patients about the following information: Cigarette smoking increases the risk of serious cardiovascular events from COC use, and that women who are over 35 years old and smoke should not use COCs [see Boxed Warning ]. Junel Fe 24 is not to be used during pregnancy; if pregnancy occurs during use of Junel Fe 24 instruct the patient to stop further use [see Warnings and Precautions 5.

Take one tablet daily by mouth at the same time every day. Instruct patients what to do in the event pills are missed [see Dosage and Administration 2. Use a back-up or alternative method of contraception when enzyme inducers are used with Junel Fe 24 [see Drug Interactions 7. COCs may reduce breast milk production; this is less likely to occur if breastfeeding is well established [see Use in Specific Populations 8.

Generics Product-Approvals-Launches. Important Safety Information Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. At Teva, we strive to deliver quality medicines to patients around the world with integrity and ethical business practices.

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