Hydroxyzine Mylan

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Hydroxyzine Mylan

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Hydroxyzine Mylan

What is Hydroxyzine Mylan? Defining the Core Substance and Identity

Property Description
Active ingredient Hydroxyzine dihydrochloride
Form Oral tablet, capsule, or solution
Pharmacological class First-generation Antihistamine (H₁ Antagonist) and Sedative Anxiolytic
General purpose To relieve itching and provide calming effects
Origin Synthetic piperazine derivative

Hydroxyzine Mylan is a prescription-only medicine (POM) whose active substance is hydroxyzine dihydrochloride, a chemically synthesized compound. This substance belongs to the piperazine derivative chemical group and is formulated as a single active ingredient product. The "Mylan" designation identifies the drug preparation as manufactured and distributed by Viatris (formerly Mylan), confirming its identity as a branded generic version of the substance Hydroxyzine. The drug is recognized for having been a subject of long-standing clinical interest, with its properties supported by pharmacological studies published over several decades.

Hydroxyzine is formally classified in two primary ways: as a first-generation antihistamine (an H₁ receptor antagonist) and as a psycholeptic, specifically a sedative anxiolytic. This dual classification reflects its action on both the body's allergic response system and the central nervous system. The World Health Organization (WHO) includes hydroxyzine on its Model List of Essential Medicines, confirming its importance as a key medicine for basic health systems. This international recognition underscores the substance's verified efficacy in managing its designated therapeutic actions globally.

The medicine's composition includes the single active substance, hydroxyzine dihydrochloride, alongside pharmaceutical excipients. It is available in several dosage forms, including oral solid preparations (tablets and capsules) and oral liquid preparations (solutions or syrups), accommodating different patient needs, such as difficulty swallowing. The primary route of administration for this medicine is oral.

What side effects are possible with Hydroxyzine Mylan?

Possible Side Effects and Safety Information

This section describes the officially documented adverse reactions and safety characteristics of hydroxyzine dihydrochloride, as defined strictly by government regulatory sources.

Adverse Reaction Scope and Frequency

The most frequently reported adverse reactions are classified as common (may affect up to 1 in 10 people) and relate to the medicine's central depressant and antihistamine activity. These include drowsiness (sedation), dry mouth, headache, and fatigue. Official labeling notes that drowsiness is typically transitory and may diminish with continued use.

Less frequent adverse reactions are classified as uncommon (e.g., dizziness, agitation, insomnia, nausea) or rare (e.g., tremor, convulsions, disorientation, hallucination).

Serious Adverse Reactions and Safety Constraints

Regulatory documents emphasize the potential for serious, though rare, adverse reactions affecting the Cardiac System, specifically the risk of QT interval prolongation and the associated severe arrhythmia, Torsade de Pointes. Severe skin reactions, such as Acute Generalized Exanthematous Pustulosis (AGEP), are also documented as rare events.

Due to the cardiac risk, the medicine is contraindicated in patients with known congenital or acquired QT prolongation, pre-existing cardiovascular conditions, or significant electrolyte imbalances, and must not be used concurrently with other medicines known to prolong the QT interval.

Population-Specific Safety Considerations

Specific regulatory safety notes exist for certain populations. Older adults are at an officially documented increased risk of adverse effects, including confusion and over-sedation, and often require a reduced maximum daily dose. Patients with renal or hepatic impairment also require dose reduction due to altered drug clearance, as stated in the prescribing information.

Overdose and Emergency Response

Overdose and When to Seek Help

A suspected overdose of Hydroxyzine Mylan is officially documented as a severe scenario that requires immediate medical attention. Regulatory authorities mandate contacting emergency services or a Poison Control center right away. Urgent medical help is necessary if manifestations include palpitations, trouble breathing, seizures, or loss of consciousness.

Documented Clinical Manifestations The documented presentations of overdose primarily involve the Central Nervous System (CNS) and the Cardiovascular System. CNS signs include profound somnolence, stupor, or depressed consciousness, alongside documented paradoxical effects such as agitation, confusion, tremor, and convulsions (seizures).

Life-Threatening Risks The most critical, life-threatening risk documented in regulatory labeling is Cardiovascular System Toxicity. This includes severe hypotension and serious cardiac arrhythmias, specifically QT interval prolongation and the potential for Torsade de Pointes.

Management and Specificity Regulatory documents confirm that no specific antidote is known, meaning treatment must be symptomatic and supportive, including measures like gastric lavage. Due to the cardiac risk, continuous ECG monitoring is mandated for management. The severity of overdose may be increased in the elderly and in individuals with pre-existing renal or hepatic impairment.

Therapeutic Uses of Hydroxyzine Mylan

What Hydroxyzine Mylan Treats: Main Uses and Benefits

Hydroxyzine Mylan is considered relevant for easing symptoms applied across domains where additional symptomatic support is needed, providing support that helps ease the overall burden of symptoms across several key areas. The medicine is commonly used for managing intense pruritus (itching), addressing emotional tension and anxiety, and acting as a pre-procedure sedative. It is particularly relevant in contexts marked by increased discomfort or tension and when short-term symptomatic assistance is appropriate.

Relief Across Key Symptom Clusters

The medication is commonly used across conditions involving episodic or fluctuating manifestations, such as chronic urticaria and specific dermatoses, to help address symptom clusters that may become intense or disruptive. Furthermore, it is considered relevant in contexts involving acute anxiety, nervousness, or tension. It may assist with maintaining a sense of stability when symptoms are more noticeable, including the control of nausea and vomiting. The use in this context is relevant because:

“The medication contributes to improved comfort during periods of heightened symptoms and supports the patient during difficult episodes by easing distress.”

Quick Fact: Primary Focus on Two Symptom Categories

The primary focus is on two symptom categories: it plays a role in managing supportive relief for symptoms related to inflammatory or irritative states (itching) and eases symptoms of increased neurological activity (tension and apprehension). This may help patients cope more steadily with symptom fluctuations.

Regulatory References

  1. Health Canada Product Monograph for Hydroxyzine

Eligibility and Restrictions for Use

Who can and cannot use Hydroxyzine Mylan? — Official Regulatory Information

The medicine’s eligibility profile is strictly defined by government regulatory agencies, which determine the populations for whom use is permitted, restricted, or absolutely prohibited.

Eligibility Scope

Category Official Regulatory Statement
Populations for whom use is allowed: Adults and children are established as eligible populations for approved indications.
Populations for whom use is not recommended: Elderly patients are generally not recommended to use the medicine due to reduced elimination and greater risk of adverse reactions.
Populations for whom use is contraindicated: Patients with known hypersensitivity to hydroxyzine, cetirizine, or levocetirizine. Patients with known acquired or congenital QT interval prolongation.

Age-Related Eligibility Rules

  • Adults/Children: Established as eligible populations for approved indications.
  • Older Adults (Geriatric): Use is generally not recommended; if use is deemed necessary, cautious dose selection is required.

Condition-Specific Eligibility Rules

  • Cardiovascular: Contraindicated in patients with QT interval prolongation. Use is restricted in those with risk factors like cardiovascular disease or significant electrolyte imbalance.
  • Organ Function: Cautious dose selection is required for older patients, reflecting the greater frequency of decreased hepatic, renal, or cardiac function.

Pregnancy and Lactation Eligibility Status

  • Pregnancy: Contraindicated in early pregnancy due to inadequate human safety data.
  • Lactation: The drug should not be given to nursing mothers.

Eligibility-Related Restrictions

  • Use is restricted in patients with conditions that predispose to QT prolongation and ventricular arrhythmia.
  • Caution is required in individuals with a family history of sudden cardiac death.

Connection to the Overall Eligibility Profile

Official regulatory documents define the eligibility structure by establishing absolute contraindications related to cardiac status, allergy, and reproductive health. Beyond these prohibitions, eligibility is limited by formal restrictions that mandate caution in populations with decreased organ function, such as the elderly, or pre-existing cardiac risk factors. This regulatory classification strictly determines the groups permitted, restricted, or prohibited from using the medicine.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section details officially documented drug interaction patterns and restrictions for hydroxyzine, based strictly on government regulatory documents.


Formal Contraindications (Prohibited Combinations)

Co-administration of hydroxyzine is formally contraindicated with any medicinal product that is known to prolong the QT interval or increase the risk of Torsade de Pointes. This includes specific Antiarrhythmics (e.g., quinidine, amiodarone), certain Antibiotics (e.g., erythromycin), Antipsychotics (e.g., haloperidol), and Antidepressants (e.g., citalopram). Use with Monoamine Oxidase Inhibitors (MAOIs) is also contraindicated.


Documented Interaction Patterns

Interaction Type Interaction Outcome (Regulatory Statement)
Pharmacodynamic (CNS) Has a potentiating action with other Central Nervous System (CNS) depressants (e.g., narcotics, barbiturates), leading to an additive effect in CNS depression.
Pharmacokinetic (Metabolic) Identified as an inhibitor of CYP2D6, potentially affecting the clearance of other medicines metabolized by this enzyme. Exposure to hydroxyzine may be increased when co-administered with potent inhibitors of CYP3A4/5.
Substance The effects of alcohol may be increased due to the additive nature of CNS depression.

Population-Specific Constraints

The interaction profile has heightened significance for certain groups. Use is not recommended in elderly patients due to reduced drug elimination, which increases the risk of interaction-related effects. The QT-prolonging contraindication is particularly emphasized for patients with existing cardiac risk factors (e.g., heart disease, electrolyte imbalances).

Mechanism of Action

The pharmacological profile of this drug is a direct result of its action across multiple signaling systems. The primary mechanism involves acting as an antagonist/inverse agonist at the Histamine H1 receptors, which are distributed both peripherally and centrally. By competitively binding to these receptors, the drug inhibits the signaling cascade normally triggered by endogenous histamine. This action results in a modification of physiological consequences related to heightened H1 receptor activation.

Additionally, the drug crosses the blood-brain barrier to influence the Central Nervous System (CNS). High H1 receptor occupancy in the brain reduces the activity of histaminergic neurons, which are involved in mediating wakefulness. The drug also exhibits affinity for serotonin (5 HT2 A) and muscarinic acetylcholine receptors, engaging mechanisms that modulate these signaling pathways. These combined mechanistic actions produce downstream effects, including the influence on smooth muscle tone and general neural activity levels.

Dosage and Administration Information

How to Use Hydroxyzine Mylan: Official Administration Guidelines

Hydroxyzine Mylan's administration is strictly governed by regulatory documentation, which outlines the approved methods, dose ranges, and necessary adjustments for specific patient populations.

Route and Frequency

The primary route of administration is oral, using tablets, capsules, or oral solution. The medicine is typically taken in divided doses multiple times daily, often three to four times a day, to achieve a consistent effect. The oral dose may be taken with or without food.

For acute, severe clinical situations, a healthcare professional may administer the medicine via deep intramuscular (IM) injection. The injection must be administered into a large muscle mass, and the intravenous (IV) route is forbidden due to tissue damage risk.

Dosing Principles and Adjustments

Official labels establish specific adult dose ranges. For the symptomatic relief of itching (pruritus), adults are commonly administered 25 mg three or four times daily. For the management of anxiety, the total daily dose typically ranges from 50 mg to 100 mg, administered in divided doses.

Duration of Use: Treatment is generally intended for short-term symptomatic management. For the treatment of anxiety, a maximum course duration of 4 weeks is often specified.

Special Population Mandatory Dose Adjustment (Examples)
Older Adults Initial dose must be reduced (e.g., halved); maximum daily dose is typically 50 mg.
Renal Impairment Total daily dose should be reduced by 50% in moderate to severe impairment.
Hepatic Impairment Total daily dose should be reduced by 33% to 50%.

Recent Clinical Evidence

Research evidence / Overview of studies for Hydroxyzine Mylan


Evidence for Symptomatic Relief of Pruritus (Itching)

Research was studied for use in the context of allergic itching. The evidence landscape includes Randomized Controlled Trials (RCTs), as well as large observational patient cohorts that were evaluated in studies examining patient-reported experiences of itching related to skin conditions like chronic urticaria and specific dermatoses. Studies monitored outcomes related to physical discomfort, often using objective itch scores, and reported measurements of changes in itch intensity observed in the study populations.

While research describes the substance’s role in conditions characterized by fluctuating or episodic manifestations, comparative evidence is lacking against all newer antihistamines is an area of ongoing scientific interest. Long-term effects are not fully established for the continued use of the substance over extended periods for chronic skin conditions.


Evidence for Symptomatic Relief of Anxiety and Tension

The evidence base for the use of hydroxyzine in studying symptoms like tension and anxiety involves intermediate-term Randomized Controlled Trials (RCTs). These studies were evaluated in adults by comparing the substance to an inactive agent (placebo) and, in some cases, to other anti-anxiety agents. Researchers examined outcomes related to systemic or functional imbalance using standardized rating scales, such as the Hamilton Anxiety Rating Scale (HAM-A).

Studies reported that measured changes in anxiety scale scores were observed in some trials compared to placebo over the defined study intervals. However, the evidence quality varies across studies, sometimes citing a high risk of bias. Furthermore, the follow-up durations were limited; research related to anti-anxiety use has not systematically assessed outcomes for more than 4 months.


Evidence for Pre-operative and Pre-procedure Sedation

The research supporting the substance's role in research exploring short-term symptom changes before a procedure primarily involves acute-period Randomized Controlled Trials. These trials monitored outcomes reflecting daily functioning or activity level immediately before and after the procedure. The outcomes examined included pre-operative anxiety scores and measures of sedation levels.


Long-Term Studies and Follow-up Duration

Regarding anxiety and tension, the follow-up durations were limited in the systematic research available. The regulatory documentation itself describes that research related to anti-anxiety use has not systematically assessed outcomes for more than 4 months. This means there is limited information for long-term outcomes and the durability of response for extended periods of use.


Research Gaps and Uncertainties

Despite a long-standing evidence base, certain research gaps have been identified: Comparative evidence is lacking for the substance against all other standard-of-care agents for anxiety. Long-term effects are not fully established for continuous use extending beyond four months. The results apply only to the populations studied under the specific conditions of the trials, meaning the research does not determine whether an individual will respond similarly outside of that studied group.

Key Studies & References

  1. Hydroxyzine hydrochloride Capsules Product Monograph (Health Canada)
  2. WHO Model List of Essential Medicines (EML) - Relevant Section on Antiallergics and Preoperative Medication
  3. The Effect of Hydroxyzine and Alprazolam Premedication on Preoperative Anxiety and Patient Satisfaction (Clinical Trial Record)

Frequently Asked Questions (FAQ)

Common questions about Hydroxyzine Mylan (FAQ)

Q: Is Hydroxyzine Mylan approved to treat sleep problems or insomnia?

A: Official indications for the medicine primarily include the symptomatic relief of anxiety, itching due to allergic conditions, and for sedation before procedures. However, regulatory documents classify the medicine as a sedative anxiolytic, and its effects on the central nervous system (CNS) are documented in official sources. This classification reflects its documented central nervous system (CNS) effects.

Q: How quickly does Hydroxyzine Mylan usually start to work for anxiety or itching?

A: Official pharmacokinetic information indicates that the drug is rapidly absorbed into the body after it is taken orally. The maximum concentration in the blood is typically reached approximately two hours after intake. The peak concentration is reached, which often corresponds to the time when effects are noted in clinical studies.

Q: What is the typical duration of effect for a single dose of Hydroxyzine Mylan?

A: The half-life of hydroxyzine in adults—the time it takes for half of the drug to be eliminated from the body—is stated in official documents to be approximately 12 hours. This time period gives an indication of how long the substance remains in the system. Official administration guidance often suggests taking the drug in divided doses.

Q: Are there any known risks associated with using Hydroxyzine Mylan for a long period of time?

A: Regulatory documents describe that treatment with this medicine is generally intended for short-term symptomatic management only. Official safety warnings stress that the drug should be used at the lowest effective dose for the shortest possible duration to minimize the risk of documented adverse effects, particularly those related to cardiac safety and over-sedation.

Q: Why is Hydroxyzine Mylan usage a concern for people who have certain heart rhythm issues?

A: Official warnings emphasize that the medicine has the potential for dose-related QT interval prolongation. This is a change in the electrical activity of the heart that, in rare cases, can lead to a serious heart rhythm abnormality called Torsade de Pointes. For this safety reason, the drug is contraindicated in people with known acquired or congenital QT prolongation or existing cardiac risk factors.

Q: What is the connection between Hydroxyzine and the drug cetirizine (Zyrtec)?

A: The connection is established in the body's metabolism process. Hydroxyzine is extensively processed by the body, and the main substance created from it is cetirizine. Official pharmacokinetic data documents that this metabolite, cetirizine, possesses significant peripheral H1-antagonist properties.

Q: Can Hydroxyzine Mylan be taken if I am pregnant or planning to become pregnant?

A: Regulatory documents state that use is contraindicated in early pregnancy due to inadequate human safety data. For this reason, official guidance is to avoid using the medicine during pregnancy.

Q: Is Hydroxyzine Mylan safe to use while breastfeeding?

A: Official regulatory information states that the medicine should not be given to nursing mothers because the drug passes into breast milk and has the potential to cause documented adverse reactions in the breastfed infant.

Q: Are there specific food or beverages, besides alcohol, that should be avoided while taking Hydroxyzine Mylan?

A: Official administration instructions state that the oral dose may be taken with or without food. Regulatory warnings specifically caution that the effects of alcohol may be increased due to the medicine's Central Nervous System (CNS) depressant properties, but no specific warnings about non-alcoholic food or beverages are consistently detailed across major labels.

Q: Why do official documents state that Hydroxyzine Mylan should be used at the lowest effective dose?

A: Official documents consistently state that the medicine should be used at the lowest effective dose for the shortest possible duration. This principle is emphasized to help mitigate the documented risk of dose-dependent adverse effects, particularly those related to cardiac safety and over-sedation.

Q: Can Hydroxyzine Mylan affect my ability to operate a car or machinery?

A: Due to the medicine's documented central nervous system (CNS) effects, including drowsiness and sedation, official warnings advise that mental alertness and ability to drive or operate machinery may be impaired, and caution should be exercised. Individuals should be aware of this potential before engaging in such activities.

Q: Why is the drug sometimes given as a syrup or solution instead of a tablet or capsule?

A: Official documents note that the medicine is supplied in various oral dosage forms, including liquid solutions. The liquid solution is supplied to accommodate diverse needs, such as difficulty swallowing or where liquid formulations are preferable for certain patient populations.

Q: Why do patients sometimes use Hydroxyzine Mylan to help with nausea or vomiting?

A: Official information notes that the medicine possesses documented antiemetic properties, which are related to its mechanism of action as an antihistamine and its anticholinergic properties. This is why the drug has historically been used in some jurisdictions for antiemetic purposes.

Q: Is Hydroxyzine Mylan considered a controlled substance?

A: No. Official regulatory status indicates that hydroxyzine is not listed as a controlled substance under the U.S. Controlled Substances Act or equivalent drug regulatory frameworks globally. This is because it is not listed in the schedules that designate controlled substances.

Q: Does taking Hydroxyzine Mylan cause any feelings of being 'high'?

A: Regulatory status indicates that the drug is not classified as a controlled substance. Official regulatory status and patient information indicate that the drug is not considered to have a potential for abuse or addiction.

Q: Is there a risk of developing dependence or addiction to Hydroxyzine Mylan?

A: Official regulatory status and patient information indicate that the drug is not classified as a controlled substance and is not considered to have a potential for abuse, dependence, or addiction.

Q: Does Hydroxyzine Mylan typically cause weight gain?

A: Weight gain is not consistently listed as a common or frequent adverse reaction in major regulatory documents. However, official listings of less common or rare adverse effects may sometimes include appetite changes.

Q: What does it mean that Hydroxyzine Mylan has an 'anticholinergic' effect?

A: Regulatory warnings mention that the drug possesses anticholinergic properties. This term means the drug can influence the action of acetylcholine, a chemical messenger in the nervous system. This property is documented to contribute to certain side effects, such as dry mouth, and is the reason caution is required for people with pre-existing conditions like glaucoma or urinary retention.

Q: Does the 'Mylan' brand of hydroxyzine have any difference from other generic versions?

A: The 'Mylan' designation identifies the drug preparation as manufactured and distributed by a specific company (Viatris, formerly Mylan). Regulatory standards require that all generic versions of the same active substance must be bioequivalent to the reference product, meaning they contain the same amount of the active ingredient and work the same way in the body.

Q: Why do some people experience dry mouth or blurred vision with Hydroxyzine Mylan?

A: Dry mouth is consistently listed as a common adverse reaction, and blurred vision is also documented as a possible effect. Both of these effects are related to the medicine’s documented anticholinergic properties, which can affect the body's production of saliva and the function of the eye muscles.

Q: What is the significance of the medication being 'rapidly absorbed from the gastrointestinal tract'?

A: Official pharmacokinetic descriptions state that rapid absorption means the drug quickly moves from the gut into the bloodstream. This is significant because it results in the drug reaching its peak concentration in the blood, and thus its effects, relatively quickly, typically within about two hours.

Q: Does Hydroxyzine Mylan have any known effect on blood pressure?

A: Changes in blood pressure, such as low blood pressure (hypotension), are not listed as common or frequent adverse effects in major regulatory documents. However, due to its documented interaction profile, caution is advised for patients who have existing cardiovascular risk factors.

Q: Can the medication affect my reaction time or coordination?

A: Official warnings state that, due to the potential for sedation and drowsiness, the drug may impair mental alertness, reaction time, or physical coordination.

Q: Does taking Hydroxyzine Mylan with food change how it works?

A: Official administration instructions state that the oral dose may be taken with or without food. This indicates that food does not prevent the body from absorbing the medicine or significantly interfere with how it works.

Q: Is it possible for Hydroxyzine Mylan to cause difficulty with urination?

A: Difficulty with urination, known as urinary retention, is documented as a potential adverse effect associated with the medicine. This is related to the drug's anticholinergic properties, and official documents advise caution for those who may be predisposed to this condition.

Q: Can Hydroxyzine Mylan affect my ability to concentrate during the day?

A: Due to the documented effects of drowsiness and sedation, the medicine has the potential to affect mental alertness and concentration during the day.

Q: How does the concentration of Hydroxyzine in the skin compare to the concentration in the blood?

A: Official pharmacokinetic data indicates that hydroxyzine is widely distributed throughout the body. Following oral administration, the concentrations found in the skin are documented to be typically higher than the concentrations found in the serum (blood).

Q: Is it possible to have a paradoxical reaction, such as increased nervousness or irritability, with Hydroxyzine Mylan?

A: Adverse reaction listings in official documents include central nervous system effects such as agitation, confusion, or insomnia. These effects can sometimes reflect a paradoxical reaction, meaning the opposite of the intended calming effect, in some individuals.

Q: What is the meaning of 'hydrochloride' or 'pamoate' in relation to the drug's name?

A: The terms 'hydrochloride' or 'pamoate' refer to the specific salt form of the active ingredient, hydroxyzine. The salt form is added during manufacturing and determines the final chemical structure and formulation of the drug.

Q: Does Hydroxyzine Mylan interact with herbal supplements?

A: While specific herbal supplements may not be listed individually in official documents, regulatory warnings emphasize caution when combining the medicine with any Central Nervous System (CNS) depressants. This category often includes certain herbal products that have sedating properties, which could lead to an additive effect of drowsiness.

Q: Is Hydroxyzine Mylan used for motion sickness?

A: Motion sickness is not consistently listed as a primary approved indication on major regulatory labels. However, official information notes that the medicine possesses documented antiemetic properties, which are related to its mechanism of action.

How should Hydroxyzine Mylan be stored and disposed of?

How to Store and Dispose of Hydroxyzine Mylan?

The storage and disposal of Hydroxyzine Mylan must strictly follow official regulatory requirements to maintain product stability and ensure safety.


Mandatory Storage Conditions

Hydroxyzine Mylan must be stored at Controlled Room Temperature, typically 20 C to 25 C. The medicine must be kept in its original container, which must be tightly closed to protect the active substance from both excess moisture and light.

Storage in environments subject to humidity and temperature fluctuations, such as a bathroom, is officially prohibited.


Safety and Disposal Rules

It is a mandatory safety instruction to KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN at all times due to its sedative properties.

Disposal must adhere to environmental protection rules. Unused or expired medicine should be returned through a drug take-back program or disposed of according to official guidance, which strictly prohibits flushing the product down the toilet or pouring it into a drain.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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