Levonorgestrel and Ethinyl Estradiol

RECENT MAJOR CHANGES Contraindications, Pregnancy (4) Removed 01/2023 Warning and Precautions, Malignant Neoplasms (5.11) 04/2022

INDICATIONS AND USAGE Levonorgestrel and ethinyl estradiol tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table 2 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and Norplant ® System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Table 2: Percentage of Women Experiencing An Unintended Pregnancy During The First Year Of Typical Use And The First Year Of Perfect Use Of Contraception And The Percentage Continuing Use At The End Of The First Year. United States. Emergency Contraceptive Pills: The FDA has concluded that certain combined oral contraceptives containing ethinyl estradiol and norgestrel or levonorgestrel are safe and effective for use as postcoital emergency contraception. Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%. 9 Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception. 10 Source: Trussell J. Contraceptive efficacy. In: Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowel D, Guest F. Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers; 1998. % of Women Experiencing an Unintended Pregnancy Within the First Year of Use % of Women Continuing Use at One Year 3 Method Typical Use 1 Perfect Use 2 (1) (2) (3) (4) Chance 4 85 85 Spermicides 5 26 6 40 Periodic abstinence 25 63 Calendar 9 Ovulation Method 3 Sympto-Thermal 6 2 Post-Ovulation 1 Cap 7 Parous women 40 26 42 Nulliparous women 20 9 56 Sponge Parous women 40 20 42 Nulliparous women 20 9 56 Diaphragm 7 20 6 56 Withdrawal 19 4 Condom 8 Female (Reality) 21 5 56 Male 14 3 61 Pill 5 71 Progestin only 0.5 Combined 0.1 IUD Progesterone T 2.0 1.5 81 Copper T380A 0.8 0.6 78 LNg 20 0.1 0.1 81 Depo-Provera ® 0.3 0.3 70 Levonorgestrel Implants (Norplant ® ) 0.05 0.05 88 Female Sterilization 0.5 0.5 100 Male Sterilization 0.15 0.10 100 1. Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2. Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3. Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4. The proportion of women who become pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the proportion who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5. Foams, creams, gels, vaginal suppositories, and vaginal film. 6. Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7. With spermicidal cream or jelly. 8. Without spermicides. 9. The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following dosage regimens of oral contraceptives to be safe and effective for emergency contraception: for tablets containing 50 mcg of ethinyl estradiol and 500 mcg of norgestrel 1 dose is 2 tablets; for tablets containing 20 mcg of ethinyl estradiol and 100 mcg of …

2 DOSAGE AND ADMINISTRATION • Take one tablet daily by mouth at the same time every day for 91 days. ( 2.1 ) • Take tablets in the order directed on the Extended-Cycle Tablet Dispenser. ( 2.2 ) 2.1 How to Start and Take Levonorgestrel and Ethinyl Estradiol Tablets Levonorgestrel and ethinyl estradiol tablets are dispensed in an Extended-Cycle Tablet Dispenser [see How Supplied/Storage and Handling ( 16 )]. Levonorgestrel and ethinyl estradiol tablets should be started on a Sunday (see Table 1). For the first cycle of a Sunday Start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration. Table 1: Instructions for Administration of Levonorgestrel and Ethinyl Estradiol Tablets Starting levonorgestrel and ethinyl estradiol tablets in females with no current use of hormonal contraception (Sunday Start) Important: Consider the possibility of ovulation and conception prior to initiation of this product. Tablet Color: • Levonorgestrel and ethinyl estradiol active tablets are light blue to blue (Day 1 to Day 84). • Levonorgestrel and ethinyl estradiol inactive tablets are white to off-white (Day 85 to Day 91). Sunday Start: For each 91-day course, take in the following order: • Take the first light blue to blue tablet (0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol) on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, take the tablet on that day. Due to the potential risk of becoming pregnant, use additional non-hormonal contraception (such as condoms or spermicide) for the first 7 days of treatment. • Take subsequent light blue to blue tablets once daily at the same time each day for a total of 84 days. • Take one white to off-white tablet (inert) daily for the following 7 days and at the same time of day that active tablets were taken. A scheduled period should occur during the 7 days that the white to off-white tablets are taken. • Begin the next and all subsequent 91-day courses of levonorgestrel and ethinyl estradiol without interruption on the same day of the week (Sunday) on which the patient began her first dose. Follow the same schedule as the initial 91-day course: a light blue to blue tablet once a day for 84 days, and a white to off-white tablet once a day for 7 days. If the patient does not immediately start her next pill pack, instruct her to protect herself from pregnancy by using a non-hormonal back-up method of contraception until she has taken a light blue to blue tablet daily for 7 consecutive days. Switching from another contraceptive method to levonorgestrel and ethinyl estradiol tablets Start levonorgestrel and ethinyl estradiol tablets: Another oral contraceptive On the day when the new pack of the previous COC would have been started Transdermal patch On the day when the next application would have been scheduled. Vaginal ring On the day when the next insertion would have been scheduled. Injection On the day when the next injection would have been scheduled. Intrauterine contraceptive (IUD) • On the day of removal. • If the IUD is not removed on first day of the patient's menstrual cycle, additional non-hormonal contraception (such as condoms or spermicide) is needed for the first seven days of the first 91-day course. Implant On the day of removal. Starting Levonorgestrel and Ethinyl Estradiol Tablets after Abortion or Miscarriage First-trimester • After a first-trimester abortion or miscarriage, levonorgestrel and ethinyl estradiol tablets may be started immediately. An additional method of contraception is not needed if levonorgestrel and ethinyl estradiol tablets are started immediately. • If levonorgestrel and ethinyl estradiol tablets are not started within 5 days after termination of the pregnancy, the patient should use additional non-hormonal contraception (such as condoms or spermicide) for the first seven days of her first 91-day course of levonorgestrel and ethinyl estradiol tablets. Second- …

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. Levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets consist of 28 tablets in the following order ( 3 ): 21 orange tablets (active), each containing 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol. 7 blue tablets (inactive placebo) each containing ferrous bisglycinate 36.5 mg. The ferrous bisglycinate tablets do not serve any therapeutic purpose. ( 3 )

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 )]. A high risk of arterial or venous thrombotic diseases ( 4 ) Liver tumors or liver disease ( 4 ) Undiagnosed abnormal uterine bleeding ( 4 ) Pregnancy ( 4 ) Breast cancer ( 4 ) Hypersensitivity of any of the components ( 4 ) Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir ( 4 )

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 Common adverse reactions (≥2% of women): headache (14%), metrorrhagia (8%), dysmenorrhea and nausea (7% each), abdominal pain and breast pain (4% each), emotional lability and acne (3% each), and depression, amenorrhea, and vaginal moniliasis (2% each) ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Acella Pharmaceuticals, LLC at 1-800-541-4802 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials 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 rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In a clinical trial with levonorgestrel 0.1 mg and ethinyl estradiol 0.02 mg tablets, a total of 1477 healthy women of child-bearing potential were enrolled and had 7870 cycles of exposure. Of these, 792 subjects had completed 6 cycles of treatment. The women ranged in age from 17 to 49 years and 87% were Caucasian. Common Adverse Reactions (≥ 2% of women): headache (14%) metrorrhagia (8%) dysmenorrhea (7%) nausea (7%) abdominal pain (4%) breast pain (4%) emotional lability (3%) acne (3%) depression (2%) amenorrhea (2%) vaginal moniliasis (2%) At the time of the report, 133 (9%) subjects had withdrawn from the study due to adverse events. The most frequent were due to headache and metrorrhagia (1% each). Other adverse events occurring in < 1% of those who discontinued included amenorrhea, depression, emotional lability, hypertension, acne, menorrhagia, nausea, hypercholesterolemia, weight gain, dysmenorrhea, and flatulence. All other reasons for discontinuation were reported by 3 or fewer subjects. 6.2 Postmarketing Experience Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 - 1.12 (Figure 1). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 1). One of these studies reported no association between breast cancer risk and COC use. The other two studies found an increased relative risk of 1.19 - 1.33 with current or recent use. Both of these studies found an increased risk of breast cancer with current use of longer duration, with relative risks ranging from 1.03 with less than one year of COC use to approximately 1.4 with more than 8-10 years of COC use. RR = relative risk; OR = odds ratio; HR = hazard ratio. “ever COC” are females with current or past COC use; “never COC use” are females that never used COCs. The following additional adverse drug reactions have been reported from worldwide postmarketing experience with levonorgestrel 0.1 mg and ethinyl estradiol 0.02 mg tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiac disorder: chest pain, dyspnea, palpitations Gastrointestinal disorders: abdominal pain, nausea, vomiting, diarrhea General disorders and administration site conditions: chest pain, fatigue, pain, malaise, injection site pain or erythema, feeling abnormal, pyrexia, condition aggravated, asthenia Immune system disorders: hypersensitivity reactions, including pruritus, rash, urticaria,erythema Injury, poisoning, and procedural complications: i njury Invest …

7 DRUG INTERACTIONS The sections below provide information on substances for which data on drug interactions with COCs are available. There is little information available about the clinical effect of most drug interactions that may affect COCs. However, based on the known pharmacokinetic effects of these drugs, clinical strategies to minimize any potential adverse effect on contraceptive effectiveness or safety are suggested. Consult the approved product labeling of all concurrently used drugs to obtain further information about interactions with COCs or the potential for metabolic enzyme or transporter system alterations. No drug-drug interaction studies were conducted with levonorgestrel and ethinyl estradiol tablets. Enzyme inducers (e.g.CYP3A4): May decrease the effectiveness of Levonorgestrel and ethinyl estradiol tablets or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with Levonorgestrel and ethinyl estradiol tablets. ( 7.1 ) 7.1 Effects of Other Drugs on Combined Oral Contraceptives Substances decreasing the plasma concentrations of COCs and potentially diminishing the efficacy of COCs: Table 5 includes substances that demonstrated an important drug interaction with levonorgestrel and ethinyl estradiol tablets. Table 5: Significant Drug Interactions Involving Substances That Affect COCs a Induction potency of St. John's wort may vary widely based on preparation. Metabolic Enzyme Inducers Clinical effect Concomitant use of COCs with metabolic enzyme inducers may decrease the plasma concentrations of the estrogen and/or progestin component of COCs. Decreased exposure of the estrogen and/or progestin component of COCs may potentially diminish the effectiveness of COCs and may lead to contraceptive failure or an increase in breakthrough bleeding. Prevention or management Counsel females to use an alternative method of contraception or a backup method when enzyme inducers are used with COCs. Continue backup contraception for 28 days after discontinuing the enzyme inducer to maintain contraceptive reliability. Examples Aprepitant, barbiturates, bosentan, carbamazepine, efavirenz, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, rifabutin, rufinamide, topiramate, products containing St. John's worta, and certain protease inhibitors (see separate section on protease inhibitors below). Colesevelam Clinical effect Concomitant use of COCs with colesevelam significantly decreases systemic exposure of ethinyl estradiol [see Clinical Pharmacology (12.3)]. Decreased exposure of the estrogen component of COCs may potentially reduce contraceptive efficacy or result in an increase in breakthrough bleeding, depending on the strength of ethinyl estradiol in the COC. Prevention or management Administer 4 or more hours apart to attenuate this drug interaction. Substances increasing the systemic exposure 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 systemic exposure of EE possibly by inhibition of conjugation. CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase systemic exposure of estrogen and/or progestin component of COCs. Human immunodeficiency virus (HIV)/ Hepatitis C virus (HCV) protease inhibitors and non-nucleoside reverse transcriptase inhibitors: Significant decreases in systemic exposure of the estrogen and/or progestin have been noted when COCs are co-administered with some HIV protease inhibitors (e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir] or some HCV protease inhibitors (e.g. boceprevir and telaprevir) and some non-nucleosidase reverse transcriptase inhibitors (e.g. nevirapine). In contrast, significant increases in systemic …

8 USE IN SPECIFIC POPULATIONS Nursing mothers: Advise use of another contraceptive method. Levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets can decrease milk production. ( 8.2 ) 8.1 Pregnancy Risk Summary Levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets are contraindicated in pregnancy because there is no reason to use combined hormonal contraceptives (CHCs) in pregnancy. Discontinue levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets if pregnancy occurs. Based on epidemiologic studies and meta-analyses, there is little or no increased risk of birth defects in the children of females who inadvertently use COCs during early pregnancy (See Data ) . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively. Human Data Epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to COCs before conception or during early pregnancy. 8.2 Lactation Risk Summary Combined hormonal contraceptives (CHCs) and/or metabolites are present in human milk and in breast-fed infants. CHCs, including levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets, can reduce milk production in breast-feeding females. This reduction can occur at any time but is less likely to occur once breast-feeding is well-established. When possible, advise the nursing female to use other methods of contraception until she discontinues breast-feeding. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets and any potential adverse effects on the breast-fed child from levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets or from the underlying maternal condition. 8.4 Pediatric Use Safety and efficacy of levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets have been established in women of reproductive age. Efficacy is expected to be the same in post-pubertal 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 Levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets have not been studied in postmenopausal women and is not indicated in this population. 8.6 Hepatic Impairment The pharmacokinetics of levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets have not been studied in women 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 )] .

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.

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 21 H 28 O 2 and the molecular weight of 312.4, and ethinyl estradiol has the empirical formula of C 20 H 24 O 2 and the molecular weight of 296.4. The molecular structures are provided below: Molecular Structures

OVERDOSAGE Symptoms of oral contraceptive overdosage in adults and children may include nausea, vomiting, and drowsiness/fatigue; withdrawal bleeding may occur in females. There is no specific antidote and further treatment of overdose, if necessary, is directed to the symptoms. Noncontraceptive Health Benefits The following noncontraceptive health benefits related to the use of oral contraceptives are supported by epidemiological studies which largely utilized oral-contraceptive formulations containing doses exceeding 0.035 mg of ethinyl estradiol or 0.05 mg of mestranol. Effects on menses: Increased menstrual cycle regularity Decreased blood loss and decreased incidence of iron-deficiency anemia Decreased incidence of dysmenorrhea Effects related to inhibition of ovulation: Decreased incidence of functional ovarian cysts Decreased incidence of ectopic pregnancies Effects from long-term use: Decreased incidence of fibroadenomas and fibrocystic disease of the breast Decreased incidence of acute pelvic inflammatory disease Decreased incidence of endometrial cancer Decreased incidence of ovarian cancer

How Supplied Levonorgestrel and ethinyl estradiol tablets USP (tablets-triphasic regimen) are available in a blister containing 28 tablets (NDC 68180-857-71). Three such blisters are packed in a carton (NDC 68180-857-73). Each cycle contains 28 tablets as follows: Six light blue tablets containing 0.05 mg of levonorgestrel and 0.03 mg of ethinyl estradiol. The light blue tablets are round, uncoated, debossed with "LU" on one side and "W31" on the other side. Five white to off white tablets containing 0.075 mg of levonorgestrel and 0.04 mg of ethinyl estradiol. The white to off white tablets are round, uncoated, debossed with "LU" on one side and "W32" on the other side. Ten pink tablets containing 0.125 mg of levonorgestrel and 0.03 mg of ethinyl estradiol. The pink tablets are round, uncoated, debossed with "LU" on one side and "W33" on the other side. Seven orange inert tablets. The orange inert tablets are round, bevel edged tablets debossed with "LU" on one side and "T22" on the other side. Storage Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. References available upon request. The brands listed are trademarks of their respective owners and are not trademarks of Lupin Pharmaceuticals, Inc. The makers of these brands are not affiliated with and do not endorse Lupin Pharmaceuticals, Inc. or its products. Distributed by: Lupin Pharmaceuticals, Inc. Naples, FL 34108 United States Manufactured by: Lupin Limited Pithampur (M.P.) – 454 775 INDIA Revised: June 2025 image