1 INDICATIONS AND USAGE

Levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets are indicated for use by females of reproductive potential to prevent pregnancy.

2 DOSAGE AND ADMINISTRATION

3 DOSAGE FORMS AND STRENGTHS

Levonorgestrel and ethinyl estradiol tablets, USP, and ferrous bisglycinate tablets are available in a 28-tablet compact blister card with:

• 21 orange, round biconvex tablets (active) debossed with “A3” on one side and each containing levonorgestrel 0.10 mg and ethinyl estradiol 0.02 mg
• 7 blue, round biconvex tablets (inactive placebo) debossed with “F1” on one side and each containing ferrous bisglycinate 36.5 mg

The ferrous bisglycinate tablets do not serve any therapeutic purpose.

4 CONTRAINDICATIONS

Levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets are contraindicated in females who are known to have or develop the following conditions:

• A high risk of arterial or venous thrombotic disease. Examples include women who are known to:
  • Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1)] .
  • Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1)] .
  • Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)] .
  • Have cerebrovascular disease [see Warnings and Precautions (5.1)] .
  • Have coronary artery disease [see Warnings and Precautions (5.1)] .
  • Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1)] .
  • Have uncontrolled hypertension [see Warnings and Precautions (5.4)] .
  • Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.6)] .
  • Have headaches with focal neurological symptoms or have migraine headaches with aura [see Warnings and Precautions (5.7)] .
    • Women over age 35 with any migraine headaches [see Warnings and Precautions (5.7)] .
• Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions (5.2)].
• Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.8)] .
• Pregnancy, because there is no reason to use COCs during pregnancy [see Warnings and Precautions (5.10) and Use in Specific Populations (8.1)] .
• Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see Warnings and Precautions (5.11)] .
• Hypersensitivity to any of the components.
• Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations [see Warnings and Precautions (5.3)].

5 WARNINGS AND PRECAUTIONS

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 Precautions ( 5.1)]
• Vascular events [see Warnings and Precautions ( 5.1)]
• Liver disease [see Warnings and Precautions ( 5.2)]

Adverse reactions commonly reported by COC users are:

• Irregular uterine bleeding
• Nausea
• Breast tenderness
• Headache

7 DRUG INTERACTIONS

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

8 USE IN SPECIFIC POPULATIONS

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

Levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets provide an oral contraceptive regimen consisting of 21 orange active tablets and 7 blue inactive tablets.

• 21 orange active tablets each containing 0.10 mg of levonorgestrel, d(-)-13β-ethyl-17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol, an estrogenic compound.
• 7 blue inactive tablets each containing 36.5 mg ferrous bisglycinate.

The inactive ingredients present in orange active tablet are FD&C Yellow #5 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, titanium dioxide, polyvinyl alcohol, talc, macrogol/polyethylene glycol 3350 NF, lecithin (soya), iron oxide black, lactose monohydrate, magnesium stearate and pregelatinized starch.

Each inactive blue tablet contains the following inactive ingredients: ferrous bisglycinate, citric acid, glycine, maltodextrin , silica, microcrystalline cellulose NF, magnesium stearate NF, croscarmellose sodium NF, colloidal silicon dioxide NF, hypromellose type 2910, titanium dioxide, polyethylene glycol 400, FD&C Red #40 Aluminum Lake, FD&C Yellow #6 Aluminum Lake and FD&C Blue #1 Aluminum Lake.

Levonorgestrel has the empirical formula of C 21H 28O 2and the molecular weight of 312.4, and ethinyl estradiol has the empirical formula of C 20H 24O 2and the molecular weight of 296.4.

The molecular structures are provided below:

12 CLINICAL PHARMACOLOGY

12.3 Pharmacokinetics

Absorption

No specific investigation of the absolute bioavailability of levonorgestrel and ethinyl estradiol tablets USP in humans has been conducted. However, literature indicates that levonorgestrel is rapidly and completely absorbed after oral administration (bioavailability about 100%) and is not subject to first-pass metabolism. Ethinyl estradiol is rapidly and almost completely absorbed from the gastrointestinal tract but, due to first-pass metabolism in gut mucosa and liver, the bioavailability of ethinyl estradiol is between 38% and 48%.

After a single dose of two levonorgestrel and ethinyl estradiol tablets to 34 women under fasting conditions, the mean (± SD) plasma area under the concentration time curve (AUC) and maximum concentration (Cmax) of levonorgestrel were 41.7 ± 18.0 ng*hour/mL and 4.4 ± 1.8ng/mL, respectively, with a median time to maximum concentration (Tmax) of 1.0 hours. The mean (±SD) plasma AUC and Cmax of ethinyl estradiol were 1167 ± 367 pg*hour/mL and 115 ± 37 pg/mL, respectively, with a median Tmax of 1.5 hours. The plasma levonorgestrel and ethinyl estradiol pharmacokinetic profi les following a single dose of two levonorgestrel and ethinyl estradiol tablets are shown in Figure 2.
Figure 2. Mean (SD) Levonorgestrel and Ethinyl Estradiol Plasma Concentrations in 34 Subjects receiving two Levonorgestrel and Ethinyl Estradiol Tablets (0.1 mg/0.02 mg) from Levonorgestrel and Ethinyl Estradiol Tablets and Ferrous Bisglycinate Tablets

Distribution

Levonorgestrel in serum is primarily bound to SHBG. Ethinyl estradiol is about 97% bound to plasma albumin. Ethinyl estradiol does not bind to SHBG, but induces SHBG synthesis.

Metabolism

Levonorgestrel:The most important metabolic pathway occurs in the reduction of the Δ4-3-oxo group and hydroxylation at positions 2α, 1β, and 16β, followed by conjugation. Most of the metabolites that circulate in the blood are sulfates of 3α, 5β-tetrahydro-levonorgestrel, while excretion occurs predominantly in the form of glucuronides. Some of the parent levonorgestrel also circulates as 17β-sulfate. Metabolic clearance rates may differ among individuals by several-fold, and this may account in part for the wide variation observed in levonorgestrel concentrations among users.

Ethinyl estradiol:Cytochrome P450 enzymes (CYP3A4) in the liver are responsible for the 2‑hydroxylation that is the major oxidative reaction. The 2-hydroxy metabolite is further transformed by methylation and glucuronidation prior to urinary and fecal excretion. Levels of Cytochrome P450 (CYP3A) vary widely among individuals and can explain the variation in rates of ethinyl estradiol 2-hydroxylation. Ethinyl estradiol is excreted in the urine and feces as glucuronide and sulfate conjugates, and undergoes enterohepatic circulation.

Excretion

The elimination half-life for levonorgestrel is approximately 34 ± 14 hours following a single dose. Levonorgestrel and its metabolites are primarily excreted in the urine (40% to 68%) and about 16% to 48% are excreted in feces. The elimination half-life of ethinyl estradiol is 17 ± 5.7 hours.

13 NONCLINICAL TOXICOLOGY

14 CLINICAL STUDIES

In a clinical trial with levonorgestrel 0.1 mg and ethinyl estradiol 0.02 mg tablets, 1,477 women aged 17-49 years, had 7,720 cycles of use. Eighty-seven percent (87%) of the women were Caucasian. The average weight was 66.4 kg with a range of 38.0-154.2 kg. Among the women in the trial, 5.3% had never used COCs.

A total of 5 pregnancies were reported. This represents an overall pregnancy rate of approximately 1 pregnancy per 100 woman-years.

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

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

Counsel patients on 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] .
• Increased risk of VTE compared to non-users of COCs is greatest after initially starting a COC or restarting (following a 4-week or greater pill-free interval) the same or a different COC [see Warnings and Precautions ( 5.1)] .
• Levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets do not protect against HIV-infection (AIDS) and other sexually transmitted diseases.
• Levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets are not to be used during pregnancy; if pregnancy occurs during use of levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets, instruct the patient to stop further use [see Use in Specific Populations ( 8.1)] .
• 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 ( 2.3)] .
• Use a back-up or alternative method of contraception when enzyme inducers are used with levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets [see Drug Interactions ( 7.1)] .
• COCs may reduce breast milk production; this is less likely to occur if breastfeeding is well established [see Use in Specific Populations ( 8.2)] .
• A woman who starts COCs postpartum and who has not yet had a period should use an additional method of contraception until she has taken a white tablet for 7 consecutive days [see Dosage and Administration ( 2.2)] .
• Amenorrhea may occur. Consider pregnancy in the event of amenorrhea at the time of the first missed period. Rule out pregnancy in the event of amenorrhea in two or more consecutive cycles [see Warnings and Precautions ( 5.8)] .

Manufactured for:

Acella Pharmaceuticals, LLC.,
1880 McFarland Pkwy.,
Alpharetta, GA 30005
1-800-541-4802

Manufactured by:

Novast Laboratories, Ltd.,
Nantong, China 226009.

Date: 08/2022

I0162 Rev. B

PATIENT INFORMATION

Levonorgestrel and Ethinyl Estradiol (LEE-voe-nor-JES-trel and EH-thih-nill-ess-tra-DYE-ole) Tablets, USP and Ferrous Bisglycinate (FARR-ouss BISS-glyy-sinn-ATE) Tablets
for oral administration

What is the most important information I should know about levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets?

Do not use levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from 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 are levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets?

Levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets are birth control pills (oral contraceptive) used by women to prevent pregnancy.

Levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets do not protect against HIV infections (AIDS) and other sexually transmitted infections.

How do levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets 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 of one clinical study of a 28-day regimen of levonorgestrel 0.1 mg/ethinyl estradiol 0.02 mg tablets, about 1 out of 100 women may get pregnant within the first year they use levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets.

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.

Do not take levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets if you:

• smoke and are over 35 years of age
• have or have had blood clots in your arms, legs, lungs, or eyes
• have a problem with your blood that makes it clot more than normal
• have certain heart valve problems or irregular heart beat that increases your risk of having blood clots
• had a stroke
• had a heart attack
• have high blood pressure that cannot be controlled by medicine
• have diabetes with kidney, eye, nerve, or blood vessel damage
• have certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision, or any migraine headaches if you are over 35 years of age
• have liver problems, including liver tumors
• have any unexplained vaginal bleeding
• are pregnant
• have or have had breast cancer or any cancer that is sensitive to female hormones
• are allergic to levonorgestrel, ethinyl estradiol, ferrous bisglycinate or any of the ingredients in levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets. Some people who are allergic to aspirin may also be allergic to FD&C Yellow No. 5 (tartrazine). FD&C Yellow No. 5 (tartrazine) is an ingredient in levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets which also may cause an allergic type reaction such as bronchial asthma. See the end of this Patient Information leaflet for a complete list of ingredients in levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets.
• take any Hepatitis C drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. This may increase levels of the liver enzyme “alanine aminotransferase” (ALT) in the blood.

If any of these conditions happen while you are taking levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets, stop taking levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets.

Before you take levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets, tell your health care provider about all of your medical conditions, including if you:

• are scheduled for surgery. Levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets may increase your risk of blood clots after surgery. You should stop using your levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets at least 4 weeks before you have surgery and not restart it until at least 2 weeks after your surgery.
• are pregnant or think you may be pregnant
• are depressed now or have been depressed in the past
• had yellowing of your skin or eyes (jaundice) caused by pregnancy (cholestasis of pregnancy)
• are breastfeeding or plan to breastfeed. Levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets may decrease the amount of breast milk you make. A small amount of the hormones in levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets may pass into your breast milk. Talk to your healthcare provider about the best birth control method for you while breastfeeding.

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

Levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets may affect the way other medicines work, and other medicines may affect how well levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets work.

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 levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets?

• Read the detailed Instructions for Use at the end of this Patient Information leaflet about the right way to take your levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets.

What are the possible serious side effects of levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets?

• Like pregnancy, levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets may cause serious side effects, including blood clots in your lungs, heart attack, or a stroke that may lead to death. Some other examples of serious blood clots include blood clots in the legs or eyes.
  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:
  • first start taking birth control pills
  • restart the same or different birth control pills after not using them for a month or more

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

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

Other serious side effects include:

• liver problems, including:
  • rare liver tumors
  • jaundice (cholestasis), especially if you previously had cholestasis of pregnancy. Call your healthcare provider if you have yellowing of your skin or eyes.
• high blood pressure.You should see your health care provider to check your blood pressure regularly.
• gallbladder problems
• changes in the sugar and fat (cholesterol and triglycerides) levels in your blood
• new or worsening headaches including migraine headaches
• depression
• possible cancer in your breast and cervix
• swelling of your skin especially around your mouth, eyes, and in your throat (angioedema).Call your healthcare provider if you have a swollen face, lips, mouth tongue or throat, which may lead to difficulty swallowing or breathing. Your chance of having angioedema is higher if you have a history of angioedema.
• dark patches of skin around your forehead, nose, cheeks and around your mouth, especially during pregnancy (chloasma).Women who tend to get chloasma should avoid spending a long time in sunlight, tanning booths, and under sun lamps while taking levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets. Use sunscreen if you have to be in the sunlight.

What are the most common side effects of levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets?

The most common side effects of levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets include:

• headache (including migraine)
• irregular vaginal bleeding (including absence of period)
• nausea
• breast tenderness, pain and discomfort
• stomach (abdominal) pain
• pain with your periods (menstrual cycle)
• mood changes, including depression
• acne
• vaginal infections

These are not all the possible side effects of levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

What else should I know about taking levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets?

• If you are scheduled for any lab tests, tell your healthcare provider you are taking levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets. Certain blood tests may be affected by levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets.

How should I store levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets?

• Store levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets and all medicines out of the reach of children.
• Store away from light.

General information about the safe and effective use of levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets for a condition for which it was not prescribed. Do not give levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets that is written for health professionals.

Do birth control pills cause cancer?

It is not known if hormonal birth control pills cause breast cancer. Some studies, but not all, suggest that there could be a slight increase in the risk of breast cancer among current users with longer duration of use.
If you have breast cancer now, or have had it in the past, do not use hormonal birth control 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 levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets?

Some women may miss a period. Irregular vaginal bleeding or spotting may happen while you are taking levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets, especially during the first few months of use. This usually is not a serious problem. If the irregular vaginal bleeding or spotting continues or happens again after you have had regular menstrual cycles call your healthcare provider. It is important to continue taking your pills on a regular schedule to prevent a pregnancy.

What if I miss my scheduled period when using levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets?

Some women miss periods on hormonal birth control, even when they are not pregnant. However, if you go 2 or more months in a row without a period, or you miss your period after a month where you did not use all of your levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets correctly, call your healthcare provider because you may be pregnant. Also call your healthcare provider if you have symptoms of pregnancy such as morning sickness or unusual breast tenderness. Stop taking levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets if you are pregnant.

What are the ingredients in levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets?

Active ingredients:Orange tablets: levonorgestrel and ethinyl estradiol.

Inactive ingredients: Orange tablets: FD&C Yellow #5 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, titanium dioxide, polyvinyl alcohol, talc, macrogol/polyethylene glycol 3350 NF, lecithin (soya), iron oxide black, lactose monohydrate, magnesium stearate and pregelatinized starch.

Inactive ingredients:Blue tablets: ferrous bisglycinate, citric acid NF, glycine, maltodextrin NF, silica, microcrystalline cellulose NF, magnesium stearate NF, croscarmellose sodium NF, colloidal silicon dioxide NF, hypromellose type 2910, titanium dioxide, polyethylene glycol 400, FD&C Red #40 Aluminum Lake, FD&C Yellow #6 Aluminum Lake and FD&C Blue #1 Aluminum Lake.

For more information, go to www.acellapharma.com or call 1-800-541-4802.

INSTRUCTIONS FOR USE

Levonorgestrel and Ethinyl Estradiol (LEE-voe-nor-JES-trel and EH-thih-nill-ess-tra-DYE-ole) Tablets, USP and Ferrous Bisglycinate (FARR-ouss BISS-glyy-sinn-ATE) Tablets
for oral administration

Important Information about taking levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets

• Take 1 pill every day at the same time. Take the pills in the order directed on your blister pack.
  Both the orange pills and the blue pills should be swallowed whole.
• Do not skip your pills, even if you do not have sex often. If you miss pills (including starting the pack late) you could get pregnant. The more pills you miss, the more likely you are to get pregnant.
• If you have trouble remembering to take levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets, talk to your healthcare provider. When you first start taking levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets, spotting or light bleeding in between your periods may occur. Contact your healthcare provider if this does not go away after a few months.
• You may feel sick to your stomach (nauseous), especially during the first few months of taking levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets. If you feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If your nausea does not go away, call your healthcare provider.
• Missing pills can also cause spotting or light bleeding, even when you take the missed pills later. On the days you take 2 pills to make up for missed pills (see below), you could also feel a little sick to your stomach.
• Some women miss periods on hormonal birth control, even when they are not pregnant. However, if you miss a period and have not taken levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets according to directions, or miss 2 periods in a row, or feel like you may be pregnant, call your health care provider. If you have a positive pregnancy test, you should stop taking levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets.
• If you have vomiting or diarrhea within 3 to 4 hours of taking your pill, take another pill of the same color from your extra blister pack. If you do not have an extra blister pack, take the next pill in your blister pack.
• Continue taking all your remaining pills in order. Start the first pill of your next blister pack the day after finishing your current blister pack. This will be 1 day earlier than originally scheduled. Continue on your new schedule.
• If you have vomiting or diarrhea for more than 1 day, your birth control pills may not work as well. Use an additional birth control method, like condoms or a spermicide, until you check with your healthcare provider.
• Stop taking levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets at least 4 weeks before you have major surgery and do not restart it until at least 2 weeks after your surgery. Be sure to use other forms of contraception (like condoms or spermicide) during this time period.

Before you start taking levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets

• Decide what time of day you want to take your pill. It is important to take it at the same time every day and in the order as directed on your blister pack.
• Have backup contraception (condoms or spermicide) available and an extra full pack of pills as needed.

When should I start taking levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets?

If you start taking levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets and you have not used a hormonal birth control method before:

• There are 2 ways to start taking your birth control pills.
  • You can either start on a Sunday (Sunday Start) or
  • You can start on the first day (Day 1) of your natural menstrual period (Day 1 Start).

Your healthcare provider should tell you when to start taking your birth control pill.

If you use the Sunday Start, use non-hormonal back-up contraception such as condoms or spermicide for the first 7 days that you take levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets. You do not need back-up contraception if you use the Day 1 Start.

If you start taking levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets and you are switching from another birth control pill:

• Start your new levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets pack on the same day that you would start the next pack of your previous birth control method.
• Do not continue taking the pills from your previous birth control pack.

If you start taking levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets and previously used a vaginal ring or transdermal patch:

• Start using levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets on the day you would have reapplied the next ring or patch.

If you start taking levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets and you are switching from a progestin-only method such as an implant or injection:

• Start taking levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets on the day of removal of your implant or on the day when you would have had your next injection.

If you start taking levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets and you are switching from an intrauterine device or system (IUD or IUS):

• Start taking levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets on the day of removal of your IUD or IUS.
• You do not need back-up contraception if your IUD or IUS is removed on the first day (Day 1) of your period. If your IUD or IUS is removed on any other day, use non-hormonal back-up contraception such as condoms or spermicide for the first 7 days that you take levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets.

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 levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets?” 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. Use non-hormonal back-up contraception such as condoms or spermicide for the first 7 days of the first cycle that you take levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets.

Instructions for using your pill pack

• Look at your levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets pill pack. See Figure A.
• Take pill 1 on the Sunday after your period starts.
• If your period starts on a Sunday, take pill “ 1” that day and refer to Day 1 Start instructions below.
• Take 1 pill every day in the order on the blister pack at the same time each day for 28 days.
• After taking the last pill on Day 28 from the blister pack, start taking the first pill from a new pack, on the same day of the week as the first pack (Sunday). Take the first pill in the new pack whether or not you are having your period.

Day 1 Start:

You will use a Day 1 Start if your healthcare provider told you to take your first pill (Day 1) on the first day of your period.

• Take 1 pill every day in the order of the blister pack, at the same time each day, for 28 days.
• After taking the last pill on Day 28 from the pill dispenser, start taking the first pill from a new pack, on the same day of the week as the first pack. Take the first pill in the new pack whether or not you are having your period.

Instructions for using your pill pack:

Step 1.

Look at your levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets pill pack. See Figure A.

The levonorgestrel and ethinyl estradiol and ferrous bisglycinate pill pack has:

• 21 orange (active) pills with hormone for Week 1 through Week 3.
• 7 blue (inactive) pills without hormones for Week 4

Step 2.

Find what day of the week you are to start taking pills. If your period begins on a day other than Sunday, place the day label strip that starts with the first day of your period. For example, if your period begins on Monday, place the day label strip with Monday as the first day. See Figure B.

Step 3.

Remove the orange pill by pressing the pill through the foil in the bottom of the pill pack. Continue taking the orange pills for 21 days.

Step 4.

On the first day of  Week 4 start taking the blue pills. Take the blue pill for 7 days. Your period should start during this time.

Step 5.

When you have taken all of the blue pills in your pill pack, get a new pill pack and start taking the orange pills.

• For a Day 1 start: Begin your next pill pack on the same day of the week as your first cycle pill pack.
• For a Sunday Start: Begin your next pill pack on Sunday.

What should I do if I miss any levonorgestrel and ethinyl estradiol  and ferrous bisglycinate pills?

If you miss 1 pill in Weeks 1, 2, or 3, follow these steps:

• Take it as soon as you remember. Take the next pill at your regular time. This means you may take 2 pills in 1 day.
• Then continue taking 1 pill every day until you finish the pack.
• You do not need to use a back-up birth control method if you have sex.

If you miss 2 pills in Week 1 or Week 2 of your pack, follow these steps:

• Take the 2 missed pills as soon as possible and the next 2 pills the next day.
• Then continue to take 1 pill every day until you finish the pack.
• Use a non-hormonal birth control method (such as a condom or spermicide) as a back-up if you have sex during the first 7 days after missing your pills.

If you miss 2 pills in a row in Week 3, or you miss 3 or more pills in a row during Weeks 1, 2, or 3 of the pack, follow these steps:

• If you are a Day 1 Starter:
  • Throw out the rest of the pill pack and start a new pack that same day.
• If you are a Sunday Starter:
  • Keep taking 1 pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack of pills that same day.
• You may not have your period this month but this is expected. However, if you miss your period 2 months in a row, call your healthcare provider because you might be pregnant.
• You could become pregnant if you have sex during the first 7 days after you restart your pills. You should use a non-hormonal birth control method (such as a condom or spermicide) as a back-up if you have sex during the first 7 days after you restart your pills.

If you have any questions or are unsure about the information in this leaflet, call your healthcare provider. They have a more technical leaflet called the Professional Labeling which you may wish to read.

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

Manufactured for:

Acella Pharmaceuticals, LLC.,
1880 McFarland Pkwy.,
Alpharetta, GA 30005
1-800-541-4802

Manufactured by:

Novast Laboratories, Ltd.,
Nantong, China 226009.

Date: 08/2022    L-0322 Rev 0822-02

Rev. B

PRINCIPAL DISPLAY PANEL - CARTON FRONT

NDC 42192-623-28
28-day regimen

1 Blister Pack
28 tablets

28-day regimen
1 Blister Pack,28 tablets
Rx Only

levonorgestrel and ethinyl estradiol tablets, USP, and ferrous bisglycinate tablets 0.1mg/0.02mg and 36.5mg

This product is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

The inactive ingredients present in orange active tablet are FD&C Yellow #5 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, titanium dioxide, polyvinyl alcohol, talc, macrogol/polyethylene glycol 3350 NF, lecithin (soya), iron oxide black, lactose monohydrate, magnesium stearate and pregelatinized starch.

Each inactive blue tablet contains the following inactive ingredients: ferrous bisglycinate, citric acid, glycine, maltodextrin , silica, microcrystalline cellulose NF, magnesium stearate NF, croscarmellose sodium NF, colloidal silicon dioxide NF, hypromellose type 2910, titanium dioxide, polyethylene glycol 400, FD&C Red #40 Aluminum Lake, FD&C Yellow #6 Aluminum Lake and FD&C Blue #1 Aluminum Lake.

1 Blister Pack, 28 tablets

Levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets

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 are contraindicated in women who are over 35 years of age and smoke.

NDC 42192-623-28
28-day regimen

PRINCIPAL DISPLAY PANEL - CARTON BACK

1 Blister Pack,
28 tablets

28-day regimen
1 blister pack,28 tablets
Rx Only

Levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets 0.1mg/0.02mg and 36.5mg

IMPORTANT - Note to Dispensing Pharmacist:Each compact dispenser contains a combination Patient Information and Instructions For Use Insert with Day Label Stickers. This should be included with each package dispensed to the patient.

Each active orange tablet (21) contains levonorgestrel 0.1 mg and ethinyl estradiol 0.02 mg.
Each inactive blue tablet (7) contains ferrous bisglycinate 36.5 mg.

Contains color additives including FD&C Yellow No. 5 (tartrazine).

Usual Dosage:One orange tablet daily for 21 consecutive days followed by one blue placebo tablet for 7 consecutive days according to prescribed schedule.

See enclosed prescribing information.

Store at 20° to 25°C (68° to 77°F); Excursions permitted to 15° to 30°C (59° to 86°F). [See USP controlled room temperature.]
Protect from light.

Keep out of the reach of children.

WARNING:Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

Manufactured for:
Avion Pharmaceuticals, LLC., Alpharetta, GA 30005
1-800-541-4802

Manufactured by:
Novast Laboratories, Ltd., Nantong, China 226009

Rx Only

L-0319 Rev 0721-01 Iss. 07/2021 Rev A C0248