JUNEL FE 24- norethindrone acetate and ethinyl estradiol and ferrous fumarate 
Teva Pharmaceuticals USA, Inc.

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use JUNEL Fe 24 safely and effectively. See full prescribing information for JUNEL Fe 24.
JUNEL® Fe 24 (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) for Oral Use
Initial U.S. Approval: 1968

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS

See Full Prescribing Information for complete boxed warning.

  • Junel Fe 24 is contraindicated in women over 35 years old who smoke. (4)
  • Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. (4)

RECENT MAJOR CHANGES

Contraindications (4) 08/2017

Warnings (5.3) 08/2017

INDICATIONS AND USAGE

Junel® Fe 24 (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) is a progestin/estrogen COC indicated for use by women to prevent pregnancy. (1) The efficacy of Junel Fe 24 in women with a body mass index (BMI) of >35 kg/m2 has not been evaluated. (1, 8.8)

DOSAGE AND ADMINISTRATION

  • Take one tablet by mouth at the same time every day for 28 days (2.1)
  • Take tablets in the order directed on the blister pack (2.1)
  • Junel Fe 24 may be administered without regard to meals (12.3)

DOSAGE FORMS AND STRENGTHS

Junel Fe 24 (norethindrone acetate and ethinyl estradiol tablets USP, 1 mg/0.02 mg and ferrous fumarate tablets) consists of 28 tablets in the following order (3):

  • 24 light yellow tablets (active), each containing 1 mg norethindrone acetate and 0.02 mg ethinyl estradiol
  • 4 brown tablets (non-hormonal inert), each containing 75 mg ferrous fumarate. The ferrous fumarate tablets do not serve any therapeutic purpose.

CONTRAINDICATIONS

  • A high risk of arterial or venous thrombotic diseases (4)
  • Liver tumors or liver disease (4)
  • Undiagnosed abnormal uterine bleeding (4)
  • Breast cancer or other estrogen- or progestin-sensitive cancer (4)
  • Pregnancy (4)
  • Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (4)

WARNINGS AND PRECAUTIONS

  • Thrombotic Disorders and Other Vascular Problems: Stop Junel Fe 24 if a thrombotic event occurs. 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. (5.1)
  • Liver disease: Discontinue Junel Fe 24 if jaundice occurs. (5.2)
  • High blood pressure: If used in women with well-controlled hypertension, monitor blood pressure and stop Junel Fe 24 if blood pressure rises significantly. (5.4)
  • Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women taking Junel Fe 24. Consider an alternative contraceptive method for women with uncontrolled dyslipidemia. (5.6)
  • Headache: Evaluate significant change in headaches and discontinue Junel Fe 24 if indicated. (5.7)
  • Bleeding Irregularities and Amenorrhea: Evaluate irregular bleeding or amenorrhea. (5.8)

ADVERSE REACTIONS

  • The most common adverse reactions (≥ 2%) were: headache, vaginal candidiasis, nausea, menstrual cramps, breast tenderness, mood changes, bacterial vaginitis, acne, and weight gain. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

  • Drugs or herbal products that induce certain enzymes (for example CYP3A4) may decrease the effectiveness of COCs or increase breakthrough bleeding. Counsel patients to use a back-up method or alternative method of contraception when enzyme inducers are used with COCs. (7.1)

USE IN SPECIFIC POPULATIONS

  • Nursing mothers: Advise use of another contraceptive method. Junel Fe 24 can decrease milk production. (8.3)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 12/2017

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 How to Start Junel Fe 24

2.2 How to Take Junel Fe 24

2.3 Missed Tablets

2.4 Advice in Case of Gastrointestinal Disturbances

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Thrombotic Disorders and Other Vascular Problems

5.2 Liver Disease

5.3 Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment

5.4 High Blood Pressure

5.5 Gallbladder Disease

5.6 Carbohydrate and Lipid Metabolic Effects

5.7 Headache

5.8 Bleeding Irregularities and Amenorrhea

5.9 COC Use Before or During Early Pregnancy

5.10 Depression

5.11 Carcinoma of the Breast and Cervix

5.12 Effect on Binding Globulins

5.13 Monitoring

5.14 Hereditary Angioedema

5.15 Chloasma

6 ADVERSE REACTIONS

6.1 Clinical Trial Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 Effects of Other Drugs on Combined Oral Contraceptives

7.2 Effects of Combined Oral Contraceptives on Other Drugs

7.3 Concomitant Use with HCV Combination Therapy – Liver Enzyme Elevation

7.4 Interactions with Laboratory Tests

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Hepatic Impairment

8.7 Renal Impairment

8.8 Body Mass Index

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

16.2 Storage Conditions

17 PATIENT COUNSELING INFORMATION

*
Sections or subsections omitted from the full prescribing information are not listed.

FULL PRESCRIBING INFORMATION

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)].

1 INDICATIONS AND USAGE

Junel® Fe 24 (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) is indicated for use by women to prevent pregnancy [see Clinical Studies (14)].

The efficacy of Junel Fe 24 in women with a body mass index (BMI) of > 35 kg/m2 has not been evaluated.

2 DOSAGE AND ADMINISTRATION

2.1 How to Start Junel Fe 24

Junel Fe 24 is dispensed in a blister card [see How Supplied/Storage and Handling (16)]. Junel Fe 24 may be started using either a Day 1 start or a Sunday start (see Table 1). For the first cycle of a Sunday Start regimen, an additional method of contraception must be used until after the first 7 consecutive days of administration.

2.2 How to Take Junel Fe 24

Table 1: Instructions for Administration of Junel Fe 24

 

Starting COCs in women not currently using hormonal contraception (Day 1 Start or Sunday Start)

Important:

Consider the possibility of ovulation and conception prior to initiation of this product.

Tablet Color:

  • Junel Fe 24 active tablets are light yellow (Day 1 to Day 24).
  • Junel Fe 24 inactive tablets are brown (Day 25 to Day 28).
 

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.e., on the day after taking the last inactive tablet).
  

Sunday Start:

For each 28-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. Due to the potential risk of becoming pregnant, use additional non-hormonal contraception (such as condoms and spermicide) for the first 7 days of the patient’s first cycle pack of Junel Fe 24.
  • Take subsequent active tablets once daily at the same time each day for a total of 24 days.
  • 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.
  • Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the Sunday after taking the last inactive tablet) and additional non-hormonal contraceptive is not needed.
 

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 24:

 
  • Transdermal patch
 
  • On the day when next application would have been scheduled.
 
  • Vaginal ring
 
  • On the day when next insertion would have been scheduled
 
  • Injection
 
  • On the day when next injection would have been scheduled
 
  • Intrauterine contraceptive
 
  • On the day of removal
  • If the IUD is not removed on first day of the patient’s menstrual cycle, additional non-hormonal contraceptive (such as condoms and spermicide) is needed for the first seven days of the first cycle pack.
 
  • Implant
 
  • On the day of removal
 

Complete instructions on proper tablet usage are located in the FDA-approved patient labeling.

Starting Junel Fe 24 after Abortion or Miscarriage

First-trimester

  • After a first-trimester abortion or miscarriage, Junel Fe 24 may be started immediately. An additional method of contraception is not needed if Junel Fe 24 is started immediately.
  • If Junel Fe 24 is not started within 5 days after termination of the pregnancy, the patient must use additional non-hormonal contraception (such as condoms and spermicide) for the first 7 days of her first 28-day course of Junel Fe 24.

Second-trimester

  • Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start Junel Fe 24 following the instructions in Table 1 for Sunday start. Use additional non-hormonal contraception (such as condoms and spermicide) for the first 7 days of the patient’s first 28-day course of Junel Fe 24 [see Contraindications (4), Warnings and Precautions (5.1), and FDA-approved Patient Labeling].
  • Starting Junel Fe 24 after Childbirth
  • Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Junel Fe 24 following the instructions in Table 1 for women not currently using hormonal contraception.
  • If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of Junel Fe 24 [see Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.1 and 8.3)].

2.3 Missed Tablets

Table 2: Instructions for Missed Junel Fe 24 Tablets

 
  • If one active tablet is missed in Weeks 1, 2 or 3
 

Take the tablet as soon as possible. Take the next pill at the regular time, and continue taking one tablet a day until the pack is finished. Back-up contraception is not needed.

 
  • 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. Continue taking one tablet a day until the pack is finished. Additional non-hormonal contraception (such as condoms and spermicide) must be used as back-up if the patient has sex within 7 days after missing tablets.

 
  • 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.

Sunday Start: Continue taking one tablet a day until Sunday, then throw out the rest of the pack and start a new pack that same day.

Additional non-hormonal contraception (such as condoms and spermicide) must be used as back-up if the patient has sex within 7 days after missing 3 tablets.

2.4 Advice in Case of Gastrointestinal Disturbances

In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures must be taken. If vomiting or diarrhea occurs within 3 to 4 hours after taking a light yellow tablet, handle this as a missed tablet [see FDA-Approved Patient Labeling].

3 DOSAGE FORMS AND STRENGTHS

Junel Fe 24 (norethindrone acetate and ethinyl estradiol tablets USP, 1 mg/0.02 mg and ferrous fumarate tablets) is available in blister packs.

Each blister pack (28 tablets) contains in the following order:

4 CONTRAINDICATIONS

Do not prescribe Junel Fe 24 to women who are known to have the following conditions:

5 WARNINGS AND PRECAUTIONS

5.1 Thrombotic Disorders and Other Vascular Problems

  • Stop Junel Fe 24 if an arterial thrombotic event or venous thromboembolic (VTE) event occurs.
  • 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 (6.2)].
  • 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 use of COCs increases the risk of VTE. However, pregnancy increases the risk of VTE as much or more than the use of COCs. The risk of VTE in women using COCs is 3 to 9 cases per 10,000 woman-years. 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. The risk of thromboembolic disease due to COCs gradually disappears after COC use is discontinued.
  • 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.

5.2 Liver Disease

Impaired Liver Function
Do not use Junel Fe 24 in women with liver disease, such as acute viral hepatitis or severe (decompensated) cirrhosis of liver [see Contraindications (4)]. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal and COC causation has been excluded. Discontinue Junel Fe 24 if jaundice develops.

Liver Tumors
Junel Fe 24 is contraindicated in women with benign and malignant liver tumors [see Contraindications (4)]. Hepatic adenomas are associated with COC use. An estimate of the attributable risk is 3.3 cases per 100,000 COC users. Rupture of hepatic adenomas may cause death through intra-abdominal hemorrhage.

Studies have shown an increased risk of developing hepatocellular carcinoma in long-term (>8 years) COC users. However, the risk of liver cancers in COC users is less than one case per million users.

5.3 Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment

During clinical trials with the Hepatitis C combination drug regimen that contains ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN), including some cases greater than 20 times the ULN, were significantly more frequent in women using ethinyl estradiol-containing medications, such as COCs. Discontinue Junel Fe 24 prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir [see Contraindications (4)]. Junel Fe 24 can be restarted approximately 2 weeks following completion of treatment with the Hepatitis C combination drug regimen.

5.4 High Blood Pressure

Junel Fe 24 is contraindicated in women with uncontrolled hypertension or hypertension with vascular disease [see Contraindications (4)]. For women with well-controlled hypertension, monitor blood pressure and stop Junel Fe 24 if blood pressure rises significantly.

An increase in blood pressure has been reported in women taking COCs, and this increase is more likely in older women with extended duration of use. The incidence of hypertension increases with increasing concentrations of progestin.

5.5 Gallbladder Disease

Studies suggest a small increased relative risk of developing gallbladder disease among COC users. Use of COCs may worsen existing gallbladder disease. A past history of COC-related cholestasis predicts an increased risk with subsequent COC use. Women with a history of pregnancy-related cholestasis may be at an increased risk for COC related cholestasis.

5.6 Carbohydrate and Lipid Metabolic Effects

Carefully monitor prediabetic and diabetic women who are taking Junel Fe 24. COCs may decrease glucose tolerance.

Consider alternative contraception for women with uncontrolled dyslipidemias. A small proportion of women will have adverse lipid changes while on COCs.

Women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs.

5.7 Headache

If a woman taking Junel Fe 24 develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue Junel Fe 24 if indicated.

Consider discontinuation of Junel Fe 24 in the case of increased frequency or severity of migraine during COC use (which may be prodromal of a cerebrovascular event).

5.8 Bleeding Irregularities and Amenorrhea

Unscheduled Bleeding and Spotting
Unscheduled (breakthrough or intracyclic) bleeding and spotting sometimes occur in patients on COCs, especially during the first three months of use. If bleeding persists or occurs after previously regular cycles, check for causes such as pregnancy or malignancy. If pathology and pregnancy are excluded, bleeding irregularities may resolve over time or with a change to a different contraceptive product.

In a clinical trial of Junel Fe 24, the frequency and duration of unscheduled bleeding and/or spotting was assessed in 743 women (3,823 28-day cycles). A total of 10 subjects (1.3%) discontinued Junel Fe 24, at least in part, due to bleeding or spotting. Based on data from the clinical trial, [24 to 38%] of women using Junel Fe 24 experienced unscheduled bleeding per cycle in the six months of the trial. The percent of women who experienced unscheduled bleeding tended to decrease over time.

Amenorrhea and Oligomenorrhea
Women who use Junel Fe 24 may experience absence of withdrawal bleeding, even if they are not pregnant. In the clinical trial with Junel Fe 24, 31 to 41% of the women using Junel Fe 24 did not have a withdrawal menses in at least one of 6 cycles of use.

Some women may experience amenorrhea or oligomenorrhea after discontinuation of COCs, especially when such a condition was preexistent.

If scheduled (withdrawal) bleeding does not occur, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule (missed one or more active tablets or started taking them on a day later than she should have), consider the possibility of pregnancy at the time of the first missed period and take appropriate diagnostic measures. If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy.

5.9 COC Use Before or During Early Pregnancy

Extensive epidemiologic studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy. Studies also do not suggest a teratogenic effect, particularly in so far as cardiac anomalies and limb reduction defects are concerned, when oral contraceptives are taken inadvertently during early pregnancy. Discontinue Junel Fe 24 use if pregnancy is confirmed.

Administration of COCs to induce withdrawal bleeding should not be used as a test for pregnancy [see Use in Specific Populations (8.1)].

5.10 Depression

Carefully observe women with a history of depression and discontinue Junel Fe 24 if depression recurs to a serious degree.

5.11 Carcinoma of the Breast and Cervix

Junel Fe 24 is contraindicated in women who currently have or have had breast cancer because breast cancer is a hormonally-sensitive [see Contraindications (4)].

There is substantial evidence that COCs do not increase the incidence of breast cancer. Although some past studies have suggested that COCs might increase the incidence of breast cancer, more recent studies have not confirmed such findings.

Some studies suggest that COCs are associated with an increase in the risk of cervical cancer or intraepithelial neoplasia. However, there is controversy about the extent to which these findings may be due to differences in sexual behavior and other factors.

5.12 Effect on Binding Globulins

The estrogen component of COCs may raise the serum concentrations of thyroxine-binding globulin, sex hormone-binding globulin, and cortisol-binding globulin. The dose of replacement thyroid hormone or cortisol therapy may need to be increased.

5.13 Monitoring

A woman who is taking COCs should have a yearly visit with her healthcare provider for a blood pressure check and for other indicated healthcare.

5.14 Hereditary Angioedema

In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema.

5.15 Chloasma

Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation while taking Junel Fe 24.

6 ADVERSE REACTIONS

The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:

Adverse reactions commonly reported by COC users are:

6.1 Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of Junel Fe 24 was evaluated in 743 subjects who participated in an open-label, randomized, active-controlled, multicenter clinical trial of Junel Fe 24 for contraception. This trial examined healthy, non-pregnant volunteers aged 18 to 45 years, who were sexually active and had a body mass index of ≤ 35 kg/m2. Subjects were followed for up to six 28-day cycles providing a total of 3,823 treatment-cycles of exposure.

Common Adverse Reactions (≥ 2% of all subjects): The most common adverse reactions reported by at least 2% of the 743 women using Junel Fe 24 were the following, in order of decreasing incidence: headache (6.3%), vaginal candidiasis (6.1%), nausea (4.6%), menstrual cramps (4.4%), breast tenderness (3.4%), mood changes (including mood swings (2.2%) and depression (1.1%)), bacterial vaginitis (3.1%), acne (2.7%), and weight gain (2.0%).

Adverse Reactions Leading to Study Discontinuation: Among the 743 women using Junel Fe 24, 46 women (6.2%) withdrew because of an adverse event. Adverse events occurring in 3 or more subjects leading to discontinuation of treatment were, in decreasing order: abnormal bleeding (0.9%), nausea (0.8%), mood changes (0.8%), menstrual cramps (0.4%), increased blood pressure (0.4%), and irregular bleeding (0.4%).

6.2 Postmarketing Experience

The following adverse reactions have been identified during post approval use of Junel Fe 24. Because these reactions are reported voluntarily from a population of uncertain size, it is difficult to reliably estimate their frequency or evaluate a causal relationship to drug exposure.

Cardiovascular: chest pain, palpitations, tachycardia, angina pectoris, myocardial infarction.

Endocrine disorders: hypothyroidism, hyperthyroidism.

Eye disorders: blurred vision, visual impairment, transient blindness, corneal thinning, change in corneal curvature (steepening).

GI disorders: nausea, vomiting, abdominal pain, constipation, pancreatitis.

Hepatobiliary disorders: cholelithiasis, cholecystitis, hepatic adenoma, hemangioma of liver.

Immune system disorders: anaphylactic reactions, including urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms.

Infections: vaginal infection.

Metabolism and nutrition disorders: change in weight or appetite (increase or decrease).

hypoglycemia, diabetes mellitus, anemia.

Musculoskeletal and connective tissue disorders: myalgia.

Skin and subcutaneous disorders: alopecia, rash (generalized and allergic), pruritus, skin discoloration, night sweats, swelling face or lips, hirsutism, skin burning sensation, erythema multiforme, erythema nodosum, hemorrhagic eruption.

Nervous system disorders: headache, dizziness, migraine, hyperesthesia, paraesthesia, hypoaesthesia, somnolence, loss of consciousness, sensory disturbance.

Psychiatric disorders: mood swings, depression, insomnia, anxiety, suicidal ideation, panic attack, changes in libido, bipolar disorder, dissociation, homicidal ideation.

Renal and urinary disorders: pollakiuria, dysuria, cystitis-like syndrome.

Reproductive system and breast disorders: breast changes (tenderness, pain, enlargement, and secretion), premenstrual syndrome, ovarian cyst, pelvic pain, ovarian cyst ruptured, pelvic fluid collection.

Vascular disorders: hot flush, thrombosis/embolism (coronary artery, pulmonary, cerebral, deep vein), migraine, transient ischemic attack, ischemic stroke.

7 DRUG INTERACTIONS

Consult the labeling of concurrently used drugs to obtain further information about interactions with oral contraceptives or the potential for enzyme alterations.

7.1 Effects of Other Drugs on Combined Oral Contraceptives

Substances decreasing the plasma concentrations of COCs and potentially diminishing the efficacy of COCs:

Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the plasma concentrations of COCs and potentially diminish the effectiveness of COCs or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of oral contraceptives including phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John’s wort. Interactions between COCs and other drugs may lead to breakthrough bleeding and/or contraceptive failure. Counsel women to use an alternative method of contraception or a back-up method when enzyme inducers are used with COCs, and to continue back-up contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability.

Substances increasing the plasma concentrations of COCs:

Co-administration of atorvastatin or rosuvastatin and certain COCs containing ethinyl estradiol (EE) increase AUC values for EE by approximately 20 to 25%. Ascorbic acid and acetaminophen may increase plasma EE concentrations, possibly by inhibition of conjugation. CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase plasma hormone concentrations.

Human immunodeficiency virus (HIV)/Hepatitis C virus (HCV) protease inhibitors and non-nucleoside reverse transcriptase inhibitors:

Significant changes (increase or decrease) in the plasma concentrations of estrogen and/or progestin have been noted in some cases of co-administration with HIV protease inhibitors (decrease [e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritnoavir, and tipranavir/ritonavir] or increase [e.g., indinavir and atazanavir/ritonavir])/HCV protease inhibitors or with non-nucleoside reverse transcriptase inhibitors (decrease [e.g., nevirapine] or increase [e.g., etravirine]).

7.2 Effects of Combined Oral Contraceptives on Other Drugs

COCs containing EE may inhibit the metabolism of other compounds (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole) and increase their plasma concentrations. COCs have been shown to decrease plasma concentrations of acetaminophen, clofibric acid, morphine, salicylic acid, and temazepam. Significant decrease in plasma concentration of lamotrigine has been shown, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.

Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone because the serum concentration of thyroid-binding globulin increases with use of COCs [see Warnings and Precautions (5.12)].

7.3 Concomitant Use with HCV Combination Therapy – Liver Enzyme Elevation

Do not co-administer Junel Fe 24 with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations [see Warnings and Precautions (5.3)].

7.4 Interactions with Laboratory Tests

The use of contraceptive steroids may influence the results of certain laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins.

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 increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to low dose COCs prior to conception or during early pregnancy.

Do not administer COCs to induce withdrawal bleeding as a test for pregnancy. Do not use COCs during pregnancy to treat threatened or habitual abortion.

Women who do not breastfeed should not start COCs earlier than 4 weeks postpartum.

8.3 Nursing Mothers

Advise the nursing mother to use another contraceptive method, when possible, until she has weaned her child. COCs can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. Small amounts of oral contraceptive steroids and/or metabolites are present in breast milk.

8.4 Pediatric Use

Safety and efficacy of Junel Fe 24 have been established in women of reproductive age. Efficacy is expected to be the same in postpubertal adolescents under the age of 18 years as for users 18 years and older. Use of this product before menarche is not indicated.

8.5 Geriatric Use

Junel Fe 24 has not been studied in postmenopausal women and is not indicated in this population.

8.6 Hepatic Impairment

The pharmacokinetics of Junel Fe 24 has not been studied in subjects with hepatic impairment. However, steroid hormones may be poorly metabolized in patients with hepatic impairment. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal and COC causation has been excluded [see Contraindications (4) and Warnings and Precautions (5.2)].

8.7 Renal Impairment

The pharmacokinetics of Junel Fe 24 has not been studied in women with renal impairment.

8.8 Body Mass Index

The safety and efficacy of Junel Fe 24 in women with a body mass index (BMI) > 35 kg/m2 has not been evaluated [see Clinical Studies (14)].

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

Junel® Fe 24 (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets) is a combination oral contraceptive for oral administration consisting of 24 light yellow active tablets containing norethindrone acetate, USP, a progestin, and ethinyl estradiol, USP, an estrogen, and 4 brown inert tablets containing ferrous fumarate, which serve no therapeutic purpose.

The chemical name of ethinyl estradiol, USP is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol, and the structural formula is:

ethinyl estradiol image

C20H24O2 M.W. 296.40

The chemical name of norethindrone acetate, USP is 17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one acetate, and the structural formula is:

norethindrone acetate image

C22H28O3 M.W. 340.46

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 penetration and endometrial changes that reduce the likelihood of implantation.

12.2 Pharmacodynamics

No specific pharmacodynamic studies were conducted with Junel Fe 24.

12.3 Pharmacokinetics

Absorption

Norethindrone acetate appears to be completely and rapidly deacetylated to norethindrone after oral administration, because the disposition of norethindrone acetate is indistinguishable from that of orally administered norethindrone. Norethindrone acetate and ethinyl estradiol are rapidly absorbed from Junel Fe 24 tablets, with maximum plasma concentrations of norethindrone and ethinyl estradiol occurring 1 to 4 hours post-dose. Both are subject to first-pass metabolism after oral dosing, resulting in an absolute bioavailability of approximately 64% for norethindrone and 43% for ethinyl estradiol.

The plasma norethindrone and ethinyl estradiol pharmacokinetics following single- and multiple-dose administrations of Junel Fe 24 tablets in 17 healthy female volunteers are provided in Figures 1 and 2, and Table 3.

Following multiple-dose administration of Junel Fe 24 tablets, mean maximum concentrations of norethindrone and ethinyl estradiol were increased by 95% and 27%, respectively, as compared to single-dose administration. Mean norethindrone and ethinyl estradiol exposures (AUC values) were increased by 164% and 51% respectively, as compared to single-dose administration of Junel Fe 24 tablets.

Steady-state with respect to norethindrone was reached by Day 17 and steady-state with respect to ethinyl estradiol was reached by Day 13.

Mean SHBG concentrations were increased by 150% from baseline (57.5 nmol/L) to 144 nmol/L at steady-state.

Figure 1. Mean Plasma Norethindrone Concentration-Time Profiles Following Single- and Multiple-Dose Oral Administration of Junel Fe 24 Tablets to Healthy Female Volunteers Under Fasting Condition (n = 17)figure 1

Figure 2. Mean Plasma Ethinyl Estradiol Concentration-Time Profiles Following Single- and Multiple-Dose Oral Administration of Junel Fe 24 Tablets to Healthy Female Volunteers Under Fasting Condition (n = 17)figure 2

Table 3. Summary of Norethindrone (NE) and Ethinyl Estradiol (EE) Pharmacokinetics Following Single- and Multiple-Dose Oral Administration of Junel Fe 24 Tablets to Healthy Female Volunteers Under Fasting Condition (n = 17)

*
The harmonic mean (0.693/mean apparent elimination rate constant) is reported for t½, and the median (range) is reported for tmax.
The SHBG concentration reported here is the pre-dose concentration.
 

Regimen

 

Analyte

 

Arithmetic Mean* (% CV) by Pharmacokinetic Parameter

 

Cmax

(pg/mL)

 

tmax

(hr)

 

AUC(0−24)

(pg/mL•h)

 

Cmin

(pg/mL)

 

t½

(hr)

 

Cavg

(pg/mL)

 

Day 1 (Single Dose)

 

NE

 

8420 (31)

 

1.0 (0.7 to 4.0)

 

33390 (40)

 

--

 

--

 

--

 

EE

 

64.5 (27)

 

1.3 (0.7 to 4.0)

 

465.4 (26)

 

--

 

--

 

--

 

SHBG

 

--

 

--

 

--

 

57.5 (37)

 

--

 

--

 

Day 24 (Multiple Dose)

 

NE

 

16400 (26)

 

1.3 (0.7 to 4.0)

 

88160 (30)

 

880 (51)

 

8.4

 

3670 (30)

 

EE

 

81.9 (24)

 

1.7 (1.0 to 2.0)

 

701.3 (28)

 

11.4 (43)

 

14.5

 

29.2 (28)

 

SHBG

 

--

 

--

 

--

 

144 (24)

 

--

 

--

 

Cmax = Maximum plasma concentration
tmax = Time of Cmax
Cmin = minimum plasma concentration at steady-state
AUC(0−24) = Area under plasma concentration versus time curve from 0 to 24 hours
t½ = Apparent first-order terminal elimination half-life
Cavg = Average plasma concentration = AUC(0–24)/24
% CV = Coefficient of Variation (%)
SHBG = Sex Hormone Binding Globulin (nmol/L)

Food Effect

A single-dose administration of Junel Fe 24 tablet with food decreased the maximum concentration of norethindrone by 11% and increased the extent of absorption by 27% and decreased the maximum concentration of ethinyl estradiol by 30% but not the extent of absorption.

Distribution

Volume of distribution of norethindrone and ethinyl estradiol ranges from 2 to 4 L/kg. Plasma protein binding of both steroids is extensive (>95%); norethindrone binds to both albumin and SHBG, whereas ethinyl estradiol binds only to albumin. Although ethinyl estradiol does not bind to SHBG, it induces SHBG synthesis.

Metabolism

Norethindrone undergoes extensive biotransformation, primarily via reduction, followed by sulfate and glucuronide conjugation. The majority of metabolites in the circulation are sulfates, with glucuronides accounting for most of the urinary metabolites.

Ethinyl estradiol is also extensively metabolized, both by oxidation and by conjugation with sulfate and glucuronide. Sulfates are the major circulating conjugates of ethinyl estradiol and glucuronides predominate in urine. The primary oxidative metabolite is 2-hydroxy ethinyl estradiol, formed by the CYP3A4 isoform of cytochrome P450. Part of the first-pass metabolism of ethinyl estradiol is believed to occur in gastrointestinal mucosa. Ethinyl estradiol may undergo enterohepatic circulation.

Excretion

Norethindrone and ethinyl estradiol are excreted in both urine and feces, primarily as metabolites. Plasma clearance values for norethindrone and ethinyl estradiol are similar (approximately 0.4 L/hr/kg). Steady-state elimination half-lives of norethindrone and ethinyl estradiol following administration of Junel Fe 24 tablets are approximately 8 hours and 14 hours, respectively.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

[See Warnings and Precautions (5.2, 5.11) and Use in Specific Populations (8.1).]

14 CLINICAL STUDIES

In an active-controlled clinical trial, 743 women 18 to 45 years of age were studied to assess the efficacy of Junel Fe 24, for up to six 28-day cycles. The racial demographic of women randomized to Junel Fe 24 was: 69.5% Caucasian, 15.5% African-American, 10.4% Hispanic, 2.3% Asian and 2.3% Native American/Other. Women with body mass index (BMI) greater than 35 mg/m2 were excluded from the study. The weight range for those women treated was 90 to 260 pounds, with a mean weight of 147 pounds. Among the women in the study randomized to Junel Fe 24, 38.9% had not used hormonal contraception immediately prior to enrolling in this study.

A total of 583 women completed 6 cycles of treatment. There were a total of 5 on-treatment pregnancies among women aged 18 to 45 years in 3,565 treatment cycles during which no back-up contraception was used. The Pearl Index for Junel Fe 24 was 1.82 (95% confidence interval 0.59 to 4.25).

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Junel® Fe 24 (norethindrone acetate and ethinyl estradiol tablets USP, 1 mg/0.02 mg and ferrous fumarate tablets*) is available only in 28 tablets and packaged in cartons of 3 blister cards of 28 tablets each.

  • NDC 0093-5328-62 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 977 on the other side and each containing 1 mg norethindrone acetate, USP and 0.02 mg ethinyl estradiol, USP.
  • 4 brown, round, flat-faced, beveled-edge, unscored (non-hormonal inert) tablets debossed with stylized b on one side and 247 on the other side and each containing 75 mg ferrous fumarate. The ferrous fumarate tablets do not serve any therapeutic purpose.
  • *Ferrous fumarate tablets are not USP for dissolution and assay.

16.2 Storage Conditions

  • Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
  • Protect from light.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

17 PATIENT COUNSELING INFORMATION

See FDA-approved Patient Labeling (Patient Information and Instructions for Use).

Counsel patients about the following information:

Manufactured For:

Teva Pharmaceuticals USA, Inc.

North Wales, PA 19454

Rev. C 12/2017

PATIENT INFORMATION

Junel Fe 24 (Joo-nell Fe 24)

(norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets)

What is the most important information I should know about Junel Fe 24?

Do not use Junel Fe 24 if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects from hormonal birth control pills, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.

What is Junel Fe 24?

Junel Fe 24 is a birth control pill (hormonal contraceptive) used by women to prevent pregnancy.

How does Junel Fe work for contraception?

Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The better you follow the directions, the less chance you have of getting pregnant.

Based on the results from the clinical study, about 1 to 4 out of 100 women may get pregnant during the first year they use Junel Fe 24.

The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant.

fewer more pregnancies

Who should not take Junel Fe 24?

Do not take Junel Fe 24 if you:

If any of these conditions happen while you are taking Junel Fe 24, stop taking Junel Fe 24 right away and talk to your healthcare provider. Use non-hormonal contraception (such as condoms and spermicide) when you stop taking Junel Fe 24.

What should I tell my healthcare provider before taking Junel Fe 24?

Tell your healthcare provider if you:

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

Junel Fe 24 may affect the way other medicines work, and other medicines may affect how well Junel Fe 24 works.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take Junel Fe 24?

Read the Instructions for Use at the end of this Patient Information.

What are the possible serious side effects of Junel Fe 24?

Serious blood clots can happen especially if you smoke, are obese, or are older than 35 years of age. Serious blood clots are more likely to happen when you:

Call your healthcare provider or go to a hospital emergency room right away if you have:

 
    • leg pain that will not go away
 
  • a sudden, severe headache unlike your usual headaches
 
  • sudden severe shortness of breath
 
  • weakness or numbness in your arm or leg
 
  • sudden change in vision or blindness
 
  • trouble speaking
 
  • chest pain
 

Other serious side effects include:

What are the most common side effects of Junel Fe 24?

These are not all the possible side effects of Junel Fe 24. For more information, ask your healthcare provider or pharmacist.

You may report side effects to the FDA at 1-800-FDA-1088.

What else should I know about taking Junel Fe 24?

How should I store Junel Fe 24?

General information about the safe and effective use of Junel Fe 24.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Junel Fe 24 for a condition for which it was not prescribed. Do not give Junel Fe 24 to other people.

This Patient Information summarizes the most important information about Junel Fe 24. You can ask your pharmacist or healthcare provider for information about Junel Fe 24 that is written for health professionals.

For more information, call Teva Pharmaceuticals at 1-888-838-2872.

Do birth control pills cause cancer?

Birth control pills do not seem to cause breast cancer. However, if you have breast cancer now, or have had it in the past, do not use birth control pills because some breast cancers are sensitive to hormones.

Women who use birth control pills may have a slightly higher chance of getting cervical cancer. However, this may be due to other reasons such as having more sexual partners.

What if I want to become pregnant?

You may stop taking the pill whenever you wish. Consider a visit with your healthcare provider for a pre-pregnancy checkup before you stop taking the pill.

What should I know about my period when taking Junel Fe 24?

Your periods may be lighter and shorter than usual. Some women may miss a period. Irregular vaginal bleeding or spotting may happen while you are taking Junel Fe 24, especially during the first few months of use. This usually is not a serious problem. It is important to continue taking your pills on a regular schedule to prevent a pregnancy.

What are the ingredients in Junel Fe 24?

Active ingredients:

Light yellow pills: norethindrone acetate and ethinyl estradiol

Inactive ingredients:

Light yellow pills: acacia, compressible sugar, D&C yellow no. 10 aluminum lake, lactose monohydrate, magnesium stearate and pregelatinized corn starch

Brown pills: ferrous fumarate, crospovidone, hydrogenated vegetable oil and microcrystalline cellulose

Manufactured For:

Teva Pharmaceuticals USA, Inc.

North Wales, PA 19454

Rev. B 8/2017

INSTRUCTIONS FOR USE

Junel Fe 24 (Joo-nell Fe 24)

(norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets)

Important Information about taking Junel Fe 24

Before you start taking Junel Fe 24:

When should I start taking Junel Fe 24?

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:

If you start taking Junel Fe 24 and you are switching from an intrauterine device or system (IUD or IUS):

Keep a calendar to track your period:

If this is the first time you are taking birth control pills, read, “When should I start taking Junel Fe 24?” above. Follow these instructions for either a Sunday Start or a Day 1 Start.

Sunday Start:

You will use a Sunday Start if your healthcare provider told you to take your first pill on a Sunday.

Day 1 Start:

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.

Instructions for using your pill pack:

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.

figure a

Figure A

Look for:

What if should I do if I miss any Junel Fe 24 light yellow pills?

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:

If you miss any of the 4 brown “reminder” pills in Week 4, throw away the pills you missed and keep taking 1 pill each day until the pack is empty. 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.

This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured For:

Teva Pharmaceuticals USA, Inc.

North Wales, PA 19454

Rev. B 8/2017

Package/Label Display Panel

image

image

Junel® Fe 24 (norethindrone acetate and ethinyl estradiol tablets USP

1 mg/0.02 mg and ferrous fumarate tablets), 28 Tablet Blister Card x 3 Carton Text

NDC 0093-5328-62                Three Blister Cards, 28 Tablets Each

Junel® Fe 24

(norethindrone acetate and

ethinyl estradiol tablets USP

1 mg/0.02 mg

and ferrous fumarate tablets*)

 

Pharmacist: Each foil pouch contains one combination “Patient Brief Summary/Detailed

Patient Package Insert,” which is to be provided to the patient with each prescription.

Provides 24 days of active therapy

Contains 3 blister cards, each containing a cycle of 28 tablets.  Each of the light yellow

tablets contain norethindrone acetate, 1 mg and ethinyl estradiol, 0.02 mg. Each of the

4 brown tablets contain ferrous fumarate, 75 mg.

*Ferrous fumarate tablets are not USP for dissolution and assay.

Rx only

SHAPING

WOMEN’S HEALTH®

TEVA

JUNEL FE  24
norethindrone acetate and ethinyl estradiol and ferrous fumarate kit
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0093-5328
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0093-5328-623 in 1 CARTON06/08/2015
1NDC:0093-5328-281 in 1 POUCH
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 1 24 
Part 2
Part 1 of 2
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 
norethindrone acetate and ethinyl estradiol tablet
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NORETHINDRONE ACETATE (UNII: 9S44LIC7OJ) (NORETHINDRONE - UNII:T18F433X4S) NORETHINDRONE ACETATE1 mg
ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U) ETHINYL ESTRADIOL0.02 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA (UNII: 5C5403N26O)  
SUCROSE (UNII: C151H8M554)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorYELLOW (light yellow) Scoreno score
ShapeROUNDSize6mm
FlavorImprint Code b;977
Contains    
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09093806/08/2015
Part 2 of 2
INERT 
inert tablet
Product Information
Route of AdministrationORAL
Inactive Ingredients
Ingredient NameStrength
FERROUS FUMARATE (UNII: R5L488RY0Q) 75 mg  in 1 mg
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Product Characteristics
ColorBROWNScoreno score
ShapeROUNDSize6mm
FlavorImprint Code b;247
Contains    
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09093806/08/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09093806/08/2015
Labeler - Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 12/2017
Document Id: 50c48477-61d5-44de-804e-40e2dcf12efc
Set id: ffbf48de-0f61-49f9-9cd5-6eb8e08040db
Version: 7
Effective Time: 20171231
 
Teva Pharmaceuticals USA, Inc.