5 WARNINGS AND PRECAUTIONS

5.1 Paradoxical Bronchospasm

Levalbuterol Inhalation Solution, USP can produce paradoxical bronchospasm, which may be life-threatening. If paradoxical bronchospasm occurs, Levalbuterol Inhalation Solution, USP should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new vial.

5.2 Deterioration of Asthma

Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of Levalbuterol Inhalation Solution, USP than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.

5.3 Use of Anti-Inflammatory Agents

Levalbuterol Inhalation Solution, USP is not a substitute for corticosteroids. The use of beta-adrenergic agonist alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti- inflammatory agents, e.g., corticosteroids, to the therapeutic regimen.

5.4 Cardiovascular Effects

Levalbuterol Inhalation Solution, USP, like other beta-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients, as measured by heart rate, blood pressure, and symptoms. Although such effects are uncommon after administration of Levalbuterol Inhalation Solution, USP at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the t-wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Therefore, Levalbuterol Inhalation Solution, USP, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

5.5 Do Not Exceed Recommended Dose

Do not exceed the recommended dose. Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma. The exact cause of death is unknown, but cardiac arrest following an unexpected development of a severe acute asthmatic crisis and subsequent hypoxia is suspected.

5.6 Immediate Hypersensitivity Reactions

Immediate hypersensitivity reactions may occur after administration of levalbuterol or racemic albuterol. Reactions have included urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. The potential for hypersensitivity must be considered in the clinical evaluation of patients who experience immediate hypersensitivity reactions while receiving Levalbuterol Inhalation Solution, USP.

5.7 Coexisting Conditions

Levalbuterol Inhalation Solution, USP, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, hypertension, and cardiac arrhythmias; in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus; and in patients who are unusually responsive to sympathomimetic amines. Clinically significant changes in systolic and diastolic blood pressure have been seen in individual patients and could be expected to occur in some patients after the use of any beta-adrenergic bronchodilator.

Changes in blood glucose may occur. Large doses of intravenous racemic albuterol have been reported to aggravate preexisting diabetes mellitus and ketoacidosis.

5.8 Hypokalemia

As with other beta-adrenergic agonist medications, Levalbuterol Inhalation Solution, USP may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects. The decrease is usually transient, not requiring supplementation.

2 DOSAGE AND ADMINISTRATION

Levalbuterol Inhalation Solution, USP is for oral inhalation only. Administer by nebulization using a standard jet nebulizer (with a face mask or mouthpiece) connected to an air compressor. Do not exceed recommended dose.

Children 6-11 years old: The recommended dosage of Levalbuterol Inhalation Solution, USP for patients 6-11 years old is 0.31 mg administered three times a day, by nebulization. Routine dosing should not exceed 0.63 mg three times a day.

Adults and Adolescents ≥ 12 years old: The recommended starting dosage of Levalbuterol Inhalation Solution, USP for patients 12 years of age and older is 0.63 mg administered three times a day, every 6 to 8 hours, by nebulization.

Patients 12 years of age and older with more severe asthma or patients who do not respond adequately to a dose of 0.63 mg of Levalbuterol Inhalation Solution, USP may benefit from a dosage of 1.25 mg three times a day.

Patients receiving the highest dose of Levalbuterol Inhalation Solution, USP should be monitored closely for adverse systemic effects, and the risks of such effects should be balanced against the potential for improved efficacy.

The use of Levalbuterol Inhalation Solution, USP can be continued as medically indicated to help control recurring bouts of bronchospasm. During this time, most patients gain optimal benefit from regular use of the inhalation solution.

If a previously effective dosage regimen fails to provide the usual response this may be a marker of destabilization of asthma and requires reevaluation of the patient and the treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.

The drug compatibility (physical and chemical), efficacy, and safety of Levalbuterol Inhalation Solution, USP when mixed with other drugs in a nebulizer have not been established.

The safety and efficacy of Levalbuterol Inhalation Solution, USP have been established in clinical trials when administered using the PARI LC Jet™ and PARI LC Plus™ nebulizers, and the PARI Master® Dura-Neb® 2000 and Dura-Neb® 3000 compressors. The safety and efficacy of Levalbuterol Inhalation Solution, USP when administered using other nebulizer systems have not been established.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Teratogenic Effects: Pregnancy Category C.

There are no adequate and well-controlled studies of Levalbuterol Inhalation Solution, USP in pregnant women. Because animal reproduction studies are not always predictive of human response, Levalbuterol Inhalation Solution, USP should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

During worldwide marketing experience, various congenital anomalies, including cleft palate and limb defects, have been reported in newborns of women treated with racemic albuterol which contains the levalbuterol isomer (active drug substance of Levalbuterol Inhalation Solution, USP). However, since multiple medications were taken during some of the pregnancies and there was no consistent pattern of anomalies, it was not possible to establish a relationship between racemic albuterol use and the occurrence of these congenital anomalies.

In animal studies, oral administration of levalbuterol HCl to pregnant New Zealand White rabbits found no evidence of teratogenicity at doses up to 25 mg/kg/day (approximately 108 times the maximum recommended daily inhalation [MRDI] dose of levalbuterol HCl for adults on a mg/m2 basis).

However, other studies demonstrated that racemic albuterol sulfate was teratogenic in mice and rabbits at doses comparable to the human therapeutic range. Pregnant mice administered racemic albuterol sulfate subcutaneously had a dose-related increased incidence of cleft palate in their fetuses (4.5% of fetuses at 0.25 mg/kg/day or greater, corresponding to approximately 0.3 times the MRDI dose, 9.3% of fetuses at 2.5 mg/kg/day, approximately 3 times the MRDI dose of levalbuterol HCl for adults on a mg/m2 basis). The drug did not induce cleft palate formation when administered subcutaneously at a dose of 0.025 mg/kg/day (approximately 0.03 times the MRDI dose of levalbuterol HCl for adults on a mg/m2 basis). In addition, oral administration of racemic albuterol sulfate to pregnant rabbits resulted in an increased incidence of cranioschisis in fetuses (approximately 215 times the MRDI dose of levalbuterol HCl for adults on a mg/m2 basis).

Non-Teratogenic Effects:

A study in which pregnant rats were dosed with radiolabeled racemic albuterol sulfate demonstrated that drug-related material is transferred from the maternal circulation to the fetus.

8.2 Labor and Delivery

Because of the potential for beta-adrenergic agonists to interfere with uterine contractility, the use of Levalbuterol Inhalation Solution, USP for the treatment of bronchospasm during labor should be restricted to those patients in whom the benefits clearly outweigh the risk.

Levalbuterol Inhalation Solution, USP has not been approved for the management of preterm labor. The benefit:risk ratio when levalbuterol HCl is administered for tocolysis has not been established. Serious adverse reactions, including maternal pulmonary edema, have been reported during or following treatment of premature labor with beta2-agonists, including racemic albuterol.

8.3 Nursing Mothers

Plasma concentrations of levalbuterol after inhalation of therapeutic doses are very low in humans. It is not known whether levalbuterol is excreted in human milk.

Because of the potential for tumorigenicity shown for racemic albuterol in animal studies and the lack of experience with the use of Levalbuterol Inhalation Solution, USP by nursing mothers, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Caution should be exercised when Levalbuterol Inhalation Solution, USP is administered to a nursing woman.

8.4 Pediatric Use

Pediatric Patients 6 Years of Age and Older

The safety and efficacy of Levalbuterol Inhalation Solution, USP have been established in pediatric patients 6 years of age and older in an adequate and well-controlled clinical trial [see Adverse Reactions (6) and Clinical Studies (14)].

Pediatric Patients less than 6 Years of Age

Levalbuterol Inhalation Solution, USP is not indicated for pediatric patients less than 6 years of age.

Clinical trials with Levalbuterol Inhalation Solution, USP in this age group failed to meet the primary efficacy endpoint and demonstrated an increased number of asthma related adverse reactions following chronic Levalbuterol Inhalation Solution, USP treatment.

Additional information describing clinical studies in which safety and efficacy were not demonstrated in pediatric patients less than 6 years of age is approved for Oak Pharmaceuticals, Inc.’s XOPENEX**®****(levalbuterol hydrochloride) Inhalation Solution. However, due to Oak Pharmaceuticals, Inc.’s marketing exclusivity rights, this product is not labeled with that pediatric information.**

8.5 Geriatric Use

Clinical studies of Levalbuterol Inhalation Solution, USP did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects. Only 5 patients 65 years of age and older were treated with Levalbuterol Inhalation Solution, USP in a 4-week clinical study [see Clinical Pharmacology (12) and Clinical Studies (14)] (n = 2 for 0.63 mg and n = 3 for 1.25 mg). In these patients, bronchodilation was observed after the first dose on day 1 and after 4 weeks of treatment. In general, patients 65 years of age and older should be started at a dose of 0.63 mg of Levalbuterol Inhalation Solution, USP. If clinically warranted due to insufficient bronchodilator response, the dose of Levalbuterol Inhalation Solution, USP may be increased in elderly patients as tolerated, in conjunction with frequent clinical and laboratory monitoring, to the maximum recommended daily dose [see Dosage and Administration (2)].

8.6 Renal Impairment

Albuterol is known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

14 CLINICAL STUDIES

Adults and Adolescents ≥ 12 Years Old

The safety and efficacy of Levalbuterol Inhalation Solution, USP were evaluated in a 4-week, multicenter, randomized, double-blind, placebo- controlled, parallel-group study in 362 adult and adolescent patients 12 years of age and older, with mild-to-moderate asthma (mean baseline FEV1 60% of predicted). Approximately half of the patients were also receiving inhaled corticosteroids. Patients were randomized to receive Levalbuterol Inhalation Solution, USP 0.63 mg, Levalbuterol Inhalation Solution, USP 1.25 mg, racemic albuterol sulfate 1.25 mg, racemic albuterol sulfate 2.5 mg, or placebo three times a day administered via a PARI LC Plus™ nebulizer and a Dura-Neb® portable compressor. Racemic albuterol delivered by a chlorofluorocarbon (CFC) metered-dose inhaler (MDI) was used on an as-needed basis as the rescue medication.

Efficacy, as measured by the mean percent change from baseline FEV1, was demonstrated for all active treatment regimens compared with placebo on day 1 and day 29. On both day 1 (see Figure 1) and day 29 (see Figure 2), 1.25 mg of Levalbuterol Inhalation Solution, USP demonstrated the largest mean percent change from baseline FEV1 compared with the other active treatments. A dose of 0.63 mg of Levalbuterol Inhalation Solution, USP and 2.5 mg of racemic albuterol sulfate produced a clinically comparable mean percent change from baseline FEV1 on both day 1 and day 29.

Figure 1: Mean Percent Change from Baseline FEV1 on Day 1, Adults and Adolescents ≥ 12 years old


Figure 2: Mean Percent Change from Baseline FEV1 on Day 29, Adults and Adolescents ≥ 12 years old



The mean time to onset of a 15% increase in FEV1 over baseline for levalbuterol at doses of 0.63 mg and 1.25 mg was approximately 17 minutes and 10 minutes, respectively, and the mean time to peak effect for both doses was approximately 1.5 hours after 4 weeks of treatment. The mean duration of effect, as measured by a > 15% increase from baseline FEV1, was approximately 5 hours after administration of 0.63 mg of levalbuterol and approximately 6 hours after administration of 1.25 mg of levalbuterol after 4 weeks of treatment. In some patients, the duration of effect was as long as 8 hours.

Children 6-11 Years Old

A multicenter, randomized, double-blind, placebo- and active-controlled study was conducted in children with mild-to-moderate asthma (mean baseline FEV1 73% of predicted) (n = 316). Following a 1-week placebo run-in, subjects were randomized to Levalbuterol Inhalation Solution, USP (0.31 mg or 0.63 mg), racemic albuterol (1.25 mg or 2.5 mg), or placebo, which were delivered three times a day for 3 weeks using a PARI LC Plus™ nebulizer and a Dura-Neb® 3000 compressor.

Efficacy, as measured by mean peak percent change from baseline FEV1, was demonstrated for all active treatment regimens compared with placebo on day 1 and day 21. Time profile FEV1 curves for day 1 and day 21 are shown in Figure 3 and Figure 4, respectively. The onset of effect (time to a 15% increase in FEV1 over test-day baseline) and duration of effect (maintenance of a > 15% increase in FEV1 over test-day baseline) of levalbuterol were clinically comparable to those of racemic albuterol.

Figure 3: Mean Percent Change from Baseline FEV1 on Day 1, Children 6-11 Years of Age


Figure 4: Mean Percent Change from Baseline FEV1 on Day 21, Children 6-11 Years of Age



16 HOW SUPPLIED/STORAGE AND HANDLING

Levalbuterol Inhalation Solution, USP is supplied in 3 mL unit-dose, low- density polyethylene (LDPE) vials as a clear, colorless, sterile, preservative-free, aqueous solution, in three different strengths of levalbuterol (0.31 mg, 0.63 mg, 1.25 mg).

Levalbuterol Inhalation Solution, USP, 0.31 mg/3 mL (foil pouch label color green) contains 0.31 mg/3 mL (0.0103%) of levalbuterol (as 0.36 mg/3 mL of levalbuterol HCl) and is available in cartons as listed below.
NDC 0115-9930-78 25 vials per carton / 25 vials per foil pouch

Levalbuterol Inhalation Solution, USP, 0.63 mg/3 mL (foil pouch label color yellow) contains 0.63 mg/3 mL (0.021%) of levalbuterol (as 0.73 mg/3 mL of levalbuterol HCl) and is available in cartons as listed below.
NDC 0115-9931-78 25 vials per carton / 25 vials per foil pouch

Levalbuterol Inhalation Solution, USP, 1.25 mg/3 mL (foil pouch label color red) contains 1.25 mg/3 mL (0.042%) of levalbuterol (as 1.44 mg/3 mL of levalbuterol HCl) and is available in cartons as listed below.
NDC 0115-9932-78 25 vials per carton / 25 vials per foil pouch

Store Levalbuterol Inhalation Solution, USP in the protective foil pouch at 20°- 25°C (68°- 77°F) [see USP Controlled Room Temperature]. Protect from light and excessive heat. Keep unopened vials in the foil pouch. Once the foil pouch is opened, the vials should be used within 2 weeks. Vials removed from the pouch, if not used immediately, should be protected from light and used within 1 week. Discard any vial if the solution is not colorless.

Rx only

PATIENT INFORMATION LEAFLET

Levalbuterol Inhalation Solution, USP

(pronounced lev" al bue' ter ol)

0.31 mg, 0.63 mg, 1.25 mg

3 mL Unit-Dose Vials

For Oral Inhalation Only ****Rx only Levalbuterol Inhalation Solution, USP is only for use with a nebulizer.

Read this Patient Information Leaflet before you start to use Levalbuterol Inhalation Solution, USP and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

What is Levalbuterol Inhalation Solution, USP?

Levalbuterol Inhalation Solution, USP is an inhaled prescription medicine used for the treatment or prevention of bronchospasm in people 6 years of age and older.

Levalbuterol Inhalation Solution, USP has not been shown to be safe and effective in children younger than 6 years of age.

Levalbuterol Inhalation Solution, USP is supplied in 3 mL unit-dose vials in three different strengths of levalbuterol (0.31 mg, 0.63 mg, 1.25 mg). The vials do not require dilution before use.

Who should not use Levalbuterol Inhalation Solution, USP?

Do not use Levalbuterol Inhalation Solution, USP if you are allergic to levalbuterol, racemic albuterol, or any of the ingredients in Levalbuterol Inhalation Solution, USP. See the end of this leaflet for a complete list of ingredients in Levalbuterol Inhalation Solution, USP.

What should I tell my doctor before using Levalbuterol Inhalation Solution, USP?

Before you use Levalbuterol Inhalation Solution, USP, tell your doctor if you have:

• had an allergic reaction to levalbuterol or racemic albuterol
• heart problems
• high blood pressure
• seizures
• diabetes
• thyroid problems
• any other medical conditions
• are pregnant or planning to become pregnant. It is not known if Levalbuterol Inhalation Solution, USP will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed. It is not known if Levalbuterol Inhalation Solution, USP passes into your breast milk. You and your doctor should decide if you will use Levalbuterol Inhalation Solution, USP or breastfeed. You should not do both.

Tell your doctor about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements. Levalbuterol Inhalation Solution, USP may affect the way other medicines work, and other medicines may affect how Levalbuterol Inhalation Solution, USP works.

Especially tell your doctor if you take:

• other asthma medicines
• heart medicines
• medicines that increase urination (diuretics)
• antidepressants
• medicine to treat chronic obstructive pulmonary disease (COPD)

Ask your doctor if you are not sure if any of your medicines are the kinds listed above.

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

How should I use Levalbuterol Inhalation Solution, USP?

• Read the step-by-step Instructions for Using Levalbuterol Inhalation Solution, USP at the end of this leaflet.
• Use Levalbuterol Inhalation Solution, USP exactly as your doctor tells you to.Do not change your dose without talking to your doctor first.
• Your doctor will tell you how many times and when to use your Levalbuterol Inhalation Solution, USP.
• An adult should help a child use Levalbuterol Inhalation Solution, USP. *Do not use your Levalbuterol Inhalation Solution, USP more often than your doctor tells you to. *Get medical help right away if Levalbuterol Inhalation Solution, USP:
  • does not work as well for your asthma symptoms or
  • your asthma symptoms get worse or
  • you need to use your Levalbuterol Inhalation Solution, USP more often than usual
• If you also use another medicine by inhalation, you should ask your doctor for instructions on when to use it while you are also using Levalbuterol Inhalation Solution, USP. *Do not mix Levalbuterol Inhalation Solution, USP with other medicines in your nebulizer. *Only use Levalbuterol Inhalation Solution, USP if it is colorless. Throw away the Levalbuterol Inhalation Solution, USP vial if the liquid medicine is not colorless.
• Do not use Levalbuterol Inhalation Solution, USP after the expiration date on the vial.

What are the possible side effects of Levalbuterol Inhalation Solution, USP?

Levalbuterol Inhalation Solution, USP can cause serious side effects including:

*sudden shortness of breath (bronchospasm). Sudden shortness of breath can happen right away after using Levalbuterol Inhalation Solution, USP. *worsening asthma *heart problems *death. If you use too much Levalbuterol Inhalation Solution, USP you can have heart or lung problems that can lead to death. *serious allergic reactions. Call your doctor and stop using Levalbuterol Inhalation Solution, USP right away if you have any symptoms of an allergic reaction such as: * swelling of the face, throat or tongue * hives * rash * breathing problems *low potassium levels in your blood

Call your doctor or go to the nearest hospital emergency room right away if you have any of the serious side effects listed above or if you have worsening lung symptoms.

The most common side effects of Levalbuterol Inhalation Solution, USP include:

• palpitations
• chest pain
• fast heart rate
• headache
• dizziness
• tremor
• nervousness

Tell your doctor if you have any side effects that bother you or that do not go away.

These are not all the possible side effects of Levalbuterol Inhalation Solution, USP. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Levalbuterol Inhalation Solution, USP?

• Store unopened Levalbuterol Inhalation Solution, USP vials in the protective foil pouch they come in at 20°-25°C (68°-77°F).
• Keep Levalbuterol Inhalation Solution, USP away from light and heat.
• When a Levalbuterol Inhalation Solution, USP foil pouch is opened, use the vials within 2 weeks.
• When Levalbuterol Inhalation Solution, USP vials are removed from the foil pouch, use them right away or within 1 week.

Keep Levalbuterol Inhalation Solution, USP and all medicines out of the reach of children.

General information about the safe and effective use of Levalbuterol Inhalation Solution, USP.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use Levalbuterol Inhalation Solution, USP for a condition for which it was not prescribed. Do not give Levalbuterol Inhalation Solution, USP to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information Leaflet summarizes the most important information about Levalbuterol Inhalation Solution, USP. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Levalbuterol Inhalation Solution, USP that is written for health professionals.

To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or****www.fda.gov/medwatch.

What are the ingredients in Levalbuterol Inhalation Solution, USP?

Active ingredient: levalbuterol hydrochloride

Inactive ingredients: sodium chloride, edetate disodium, sulfuric acid, and water

Instructions for Using Levalbuterol Inhalation Solution, USP

Levalbuterol Inhalation Solution, USP vial (see Figure A):


Figure A

---

Using your Levalbuterol Inhalation Solution, USP:

Read the following Steps before using your Levalbuterol Inhalation Solution, USP. If you have any questions, ask your doctor or pharmacist.

Step 1. Open the foil pouch by tearing the notched edge along the seam of the pouch (see Figure B). Remove 1 vial to be used right away. Keep the rest of the unused vials in the foil pouch to protect them from light and heat.


Figure B

Step 2. Hold the vial in your hands. Make sure your thumb and finger cover the twist-off tabs below the top (see Figure C).


Figure C

---

Step 3. While holding the top firmly between your thumb and finger, twist the body of the vial to open the vial (see Figure C).

Step 4. Throw away the top of the vial and squeeze the entire contents of the vial into the nebulizer reservoir (see Figure D).


Figure D

---

Step 5. Connect the nebulizer reservoir to the mouthpiece (see Figure E.1) or face mask (see Figure E.2).

		
	Figure E.1	Figure E.2

Step 6. Connect the nebulizer to the compressor (see Figure F).


Figure F

---

Step 7. Sit in a comfortable, upright position. Place the mouthpiece in your mouth (see Figure G.1) or put on your face mask (see Figure G.2). Turn on the compressor.

		
	Figure G.1	Figure G.2

Step 8. Breathe as calmly, deeply, and evenly as possible until no more mist is seen in the nebulizer reservoir. Your treatment will take about 5 to 15 minutes. When you do not see any mist in the nebulizer reservoir, your treatment is finished.

Step 9. Clean and store your nebulizer. See the manufacturer's instructions that come with your nebulizer for how to clean and store your nebulizer.

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

Manufactured by:
The Ritedose Corporation
Columbia, SC 29203 USA

Distributed by:
Amneal Pharmaceuticals LLC
****Bridgewater, NJ 08807

To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Rev. 12-2018-00

---