Provigil (modafinil) is a prescription medication. It’s most often used to treat excessive sleepiness caused by narcolepsy, obstructive sleep apnea, and shift work.

Provigil belongs to a class of medications called stimulants. It comes as 100-mg and 200-mg oral tablets.

Studies show that Provigil increases the ability to stay awake compared to a placebo in people with narcolepsy, sleep apnea, or shift work sleep disorder. Provigil is considered a first-choice medication option for decreasing sleepiness in people with these conditions.

Is Provigil a controlled substance?

Yes, Provigil is a controlled substance. It’s classified as a schedule IV prescription drug. This means it has an accepted medical use but may also cause physical or psychological dependence and may be abused.

The government has created special rules for how schedule IV drugs can be prescribed by a doctor and dispensed by a pharmacist. Your doctor or pharmacist can tell you more.

Provigil is available in a generic form called modafinil.

Generic drugs are often less expensive than the brand-name version. In some cases, the brand-name drug and the generic version may be available in different forms and strengths.

Provigil can cause mild or serious side effects. The following list contains some of the key side effects that may occur while taking Provigil. This list does not include all possible side effects.

For more information on the possible side effects of Provigil, or tips on how to deal with a troubling side effect, talk with your doctor or pharmacist.

More common side effects

The more common side effects of Provigil can include:

  • headache
  • nausea
  • feelings of nervousness
  • anxiety
  • trouble sleeping
  • loss of appetite
  • dry mouth
  • dizziness
  • runny nose
  • diarrhea
  • upset stomach
  • back pain
  • chest pain

Some people may also experience less frequent side effects, such as:

  • rapid heartbeat
  • depression
  • constipation
  • vertigo
  • tremor
  • confusion

Serious side effects

Serious side effects from Provigil aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

Severe rash

In rare cases, Provigil can cause a severe rash within the first few weeks of taking it. It may occur along with vomiting and fever, and may lead to problems with the liver, lungs, kidneys, and heart.

If you develop a rash while taking Provigil, call your doctor right away. If the rash is related to Provigil, you’ll likely need to stop taking the drug.

Serious allergic reaction

Rarely, people who take Provigil may have an allergic reaction. Symptoms can include:

  • severe rash or hives
  • trouble breathing or swallowing
  • swelling of your lips, tongue, or face
  • rapid heartbeat

Heart effects

These effects are more likely to happen in people with a heart condition or high blood pressure, but can occur in people without heart conditions. Symptoms can include:

  • chest pain
  • palpitations (pounding heartbeat)
  • trouble breathing
  • high blood pressure requiring treatment with medication

If have these side effects, talk to your doctor right away. Your doctor may need to check you for heart conditions, or monitor your heart rate and blood pressure.

Mental health effects

Some people who take Provigil can have mood or mental health-related side effects, such as:

  • anxiety
  • depression
  • feelings of nervousness
  • confusion
  • irritability

In some cases, these side effects can become severe. Although rare, some people have had thoughts of suicide, symptoms of psychosis (such as delusions or hallucinations), mania, and aggression. These side effects are more likely to happen in people who have had mental health problems in the past.

Suicide prevention

If you know someone at immediate risk of self-harm, suicide, or hurting another person:

  • Ask the tough question: “Are you considering suicide?”
  • Listen to the person without judgment.
  • Call 911 or the local emergency number, or text TALK to 741741 to communicate with a trained crisis counselor.
  • Stay with the person until professional help arrives.
  • Try to remove any weapons, medications, or other potentially harmful objects.

If you or someone you know is having thoughts of suicide, a prevention hotline can help. The 988 Suicide and Crisis Lifeline is available 24 hours a day at 988. During a crisis, people who are hard of hearing can use their preferred relay service or dial 711 then 988.

Click here for more links and local resources.

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Long-term side effects

Taking Provigil long-term may increase the risk of developing psychological and physical dependence. However, this side effect seems to be rare, and may be more likely when the drug is used in high doses, or if it’s misused or abused.

Provigil abuse is not common. It’s more likely to occur in people who have a history of alcohol or drug abuse.

Most people don’t seem to have withdrawal symptoms when stopping treatment with Provigil.

Driving warning

Before you drive while taking Provigil, wait until you know how the drug will affect you. If you feel lightheaded, confused, or sleepy after taking it, don’t drive or use dangerous equipment.

Although Provigil helps reduce sleepiness in people with narcolepsy or other conditions, it may not provide full wakefulness. In addition, Provigil might cause certain side effects, such as dizziness or confusion, that may impair your ability to drive.

The Food and Drug Administration (FDA) approves drugs such as Provigil to treat certain conditions. In addition to these uses, Provigil is sometimes used for purposes that aren’t approved by the FDA.

Approved uses for Provigil

Provigil is FDA-approved for improving daytime sleepiness caused by the following medical conditions:

  • narcolepsy
  • obstructive sleep apnea
  • shift work sleep disorder

Uses that are not approved

Provigil is sometimes used off-label for uses that are not FDA-approved. Off-label use means the drug has been approved for one use, but is used for another. In other cases, Provigil may be misused for purposes that are not approved.

Provigil for ADHD

Provigil is used off-label to treat attention deficit-hyperactivity disorder (ADHD). However, it’s not considered a first-choice medication for this purpose.

Although some research shows that it can improve symptoms of ADHD, other research shows no benefit. Provigil is not currently recommended by the American Academy of Pediatrics for treating ADHD.

Provigil for depression

Provigil is used off-label for depression in people for whom antidepressants alone don’t fully treat their condition. Taking Provigil along with antidepressants has been shown to improve symptoms of fatigue and excessive tiredness in people who have depression.

Provigil for MS

Provigil is sometimes prescribed off-label to treat symptoms of fatigue caused by conditions such as multiple sclerosis (MS). An analysis of clinical studies showed that Provigil can improve symptoms of fatigue in people with MS.

Provigil for anxiety

Provigil is not usually prescribed off-label for treating anxiety. However, some people say that Provigil gives them more focus, calm, and confidence in social or stressful situations. Because of this, Provigil may be misused for treating social anxiety or performance anxiety.

Other people who take Provigil say that it causes more anxiety, or worsens anxiety symptoms.

If you have anxiety, talk with your doctor about what treatment options that might reduce your symptoms. Don’t take Provigil unless your doctor prescribes it for you.

Provigil for weight loss

Provigil can cause loss of appetite in some people who take it. Because of this side effect, some people misuse Provigil as a weight loss aid.

Don’t take Provigil unless your doctor has prescribed it for you. Misusing this drug could lead to abuse and dependence.

The Provigil dosage your doctor prescribes will depend on several factors. These include:

  • the type and severity of the condition you’re using Provigil to treat
  • your age
  • other medical conditions you may have

Typically, your doctor will start you on a low dosage and adjust it over time to reach the dosage that’s right for you. They’ll ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to suit your needs.

Dosage for narcolepsy and sleep apnea

For daytime sleepiness caused by narcolepsy or obstructive sleep apnea, the typical dosage is 200 mg once a day in the morning. Higher doses are sometimes used, up to 400 mg daily. However, these doses may not be any more effective than 200 mg daily.

Dosage for shift work sleep disorder

For excessive sleepiness due to shift work sleep disorder, the typical dosage is 200 mg taken about one hour before the start of your work shift.

Dosage for people with liver problems

If you have severe liver problems, your doctor will likely prescribe a lower dosage. The recommended dosage for people with this condition is typically 100 mg daily.

Dosage for seniors

Seniors may be more sensitive to the effects of Provigil, especially side effects. If you’re over 65 years of age, your doctor may prescribe a lower dosage.

What if I miss a dose?

If you miss a dose, take it as soon as you remember. Remember that Provigil will keep you awake, so don’t take it unless you plan to be awake for several hours. If it’s close to your bedtime, skip the missed dose and take it the next day at the normal time.

Never try to catch up by taking two doses at a time. This can cause dangerous side effects.

Will I need to use this drug long-term?

Yes, Provigil is usually taken long-term by people with narcolepsy or sleep apnea. These are chronic conditions that often require long-term treatment to improve symptoms of daytime sleepiness.

How you take Provigil may depend on what you’re taking it for.


If you’re taking Provigil to reduce daytime sleepiness due to narcolepsy or sleep apnea, you’ll take it in the morning.

If you’re taking Provigil for shift work sleep disorder, you’ll likely take it one hour before your work shift.

Provigil will keep you awake for several hours, so you shouldn’t take it too close to your bedtime.

Taking Provigil with food

You can take Provigil with or without food. If the drug upsets your stomach, taking it with food might reduce this side effect. However, if you take it with food, Provigil might take slightly longer to start working.

Can Provigil be crushed?

Provigil tablets should not be crushed or split. If you’re having trouble taking Provigil, talk to your doctor or pharmacist about options that can make swallowing the tablet easier.

Urine drug screening tests usually don’t detect Provigil in the urine.

Although Provigil is a stimulant, its chemical makeup is different from the makeup of other stimulants, such as amphetamines. Therefore, it probably wouldn’t cause a false positive test result for amphetamines. However, there’s very little scientific information available about this.

Although Provigil may not appear in a drug test, if you’re an athlete, it’s important to know that stimulants are often prohibited. This includes Provigil.

For instance, the National Collegiate Athletic Association lists stimulants such as Provigil as prohibited during sports. Be sure to talk with your coach if you’re taking Provigil for a medical condition.

Provigil can interact with several other medications. It can also interact with certain supplements as well as certain foods.

Different interactions can cause different effects. For instance, some can interfere with how well a drug works, while others can cause increased side effects.

Provigil and other medications

Below is a list of medications that can interact with Provigil. This list does not contain all drugs that may interact with Provigil.

Before taking Provigil, be sure to tell your doctor and pharmacist about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Drugs that change the effects of Provigil

Several medications can lessen the activity of an enzyme called cytochrome P450 3A4 in your body. Taking these drugs with Provigil can cause your body to get rid of Provigil more slowly. This can cause more Provigil side effects.

Examples of these medications include:

  • antiviral medications such as:
    • cobicistat (Tybost)
    • darunavir (Prezista)
    • ritonavir (Norvir)
    • Viekira Pak, Viekira XR (dasabuvir, ombitasvir, paritaprevir, ritonavir)
  • antifungal medications such as:
    • fluconazole (Diflucan)
    • itraconazole (Sporanox, Onmel)
    • ketoconazole
  • antibiotic medications such as:
    • clarithromycin (Biaxin)
    • erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin)
  • heart medications such as:
    • amiodarone (Pacerone, Nexterone)
    • diltiazem (Cardizem, Cartia XT, Diltzac, Taztia XT, Tiazac, others)
    • verapamil (Calan, Verelan)

Drugs that may be affected by Provigil

Provigil can increase the activity of an enzyme called cytochrome P450 3A4 in your body. This can cause your body to get rid of certain medications more quickly. As a result, these medications may become less effective.

Examples of these medications include:

  • oral contraceptives (consider using a backup method of birth control while taking Provigil, and for one month after stopping it)
  • cyclosporine (Neoral, Sandimmune)
  • midazolam
  • triazolam (Halcion)

Provigil can reduce the activity of enzymes called cytochrome P450 2C19 in your body. This can cause your body to get rid of certain medications more slowly. This may cause more medication side effects.

Examples of these medications include:

  • clomipramine (Anafranil)
  • diazepam (Valium)
  • omeprazole (Prilosec)
  • phenytoin (Dilantin, Phenytek)
  • propranolol (Inderal LA, InnoPran XL)

Many other medications may be affected when taken with Provigil. If you take other medications, talk to your doctor and pharmacist about how to avoid potential interactions.

Monoamine oxidase inhibitors (MOAIs)

Taking Provigil with monoamine oxidase inhibitors (MAOIs) might lead to dangerous side effects such as very high blood pressure, chest pain, severe headache, and increased body temperature. Provigil should not be taken within 14 days of using an MAOI.

Examples of MAOIs include:

  • isocarboxazid (Marplan)
  • linezolid (Zyvox)
  • phenelzine (Nardil)
  • selegiline (Eldepryl)
  • tranylcypromine (Parnate)


Taking Provigil with warfarin (Coumadin, Jantoven) may make your body get rid of warfarin more slowly. This may increase the effects of warfarin and increase your risk of side effects such as bleeding.

Provigil and herbs and supplements

Provigil may interact with certain supplements or herbal products you may be taking. Examples of these include:

  • acacia rigidula
  • bitter orange
  • green tea
  • guarana
  • hordenine
  • Indian snakeroot
  • octodrine
  • St. John’s wort
  • yohimbe


Taking Provigil with marijuana might change how marijuana affects you. Provigil alters enzymes in your body that control how quickly the body gets rid of marijuana chemicals that cause you to get high. This might increase or decrease the effects and side effects of marijuana.

Provigil and foods

Provigil may interact with certain foods you may eat.

Fruit juices

Drinking certain fruit juices, such as grapefruit juice and orange juice, while taking Provigil might change how your body handles the drug. This could increase the amount of Provigil in your body and increase your risk of side effects.

Foods and beverages that contain caffeine

Caffeine in foods and beverages might add to the stimulant effects of Provigil. This can increase the risk of stimulant-related side effects such as anxiety, nervousness, trouble sleeping, and others.

Examples of foods and drinks that contain caffeine include:

  • coffee
  • chocolate
  • soda
  • tea (such as black, green, and oolong)

You should avoid drinking alcohol while you take Provigil.

Alcohol can make you feel tired and sleepy. This can decrease the effects of Provigil, which is typically used to help you feel less tired and sleepy.

Some people who take Provigil can have changes in mood or thinking that makes them feel more focused and more confident. Although not common, some people may also experience feelings of euphoria. Some people call this a “high.”

This effect can lead to misuse or abuse of Provigil for nonmedical uses. Abuse or misuse is more likely to occur in people who have abused alcohol or drugs in the past.

Other drugs are available that can treat your condition. Some may be better suited for you than others. If you’re interested in finding an alternative to Provigil, talk to your doctor to learn more about other medications that may work well for you.

Examples of other medications that can be used to decrease daytime sleepiness in people with narcolepsy, sleep apnea, or shift work sleep disorder include:

  • amphetamine (Adzenys XR-ODT, Adzenys ER, Dyanavel XR, Evekeo)
  • Adderall (amphetamine and dextroamphetamine salts)
  • armodafinil (Nuvigil)
  • dextroamphetamine (Dexedrine, ProCentra, Zenzedi)
  • lisdexamfetamine (Vyvanse)
  • methylphenidate (Aptensio XR, Concerta, Cotempla XR-ODT, Daytrana, Methylin, QuilliChew ER, Quillivant XR, Ritalin)
  • sodium oxybate (Xyrem)

Note: Some of the drugs listed here are used off-label to treat these specific conditions.

You may wonder how Provigil compares to certain drugs such as Nuvigil. Provigil and Nuvigil are very similar medications. In fact, Nuvigil is called an “isomer” of Provigil. That means that their chemical makeup is virtually identical, but the chemicals are arranged slightly differently.

The generic name of Nuvigil is armodafinil.


Both Provigil and Nuvigil are FDA-approved for the same uses. They’re both used for treating daytime sleepiness caused by:

  • narcolepsy
  • obstructive sleep apnea
  • shift work sleep disorder

Drug forms

Provigil and Nuvigil are both available as oral tablets that are usually taken once daily.

Side effects and risks

Provigil and Nuvigil cause very similar common and serious side effects.

More common side effects

Examples of more common side effects that can be caused by both Provigil and Nuvigil include:

  • headache
  • nausea
  • feelings of nervousness
  • anxiety
  • trouble sleeping
  • loss of appetite
  • dry mouth
  • dizziness
  • diarrhea
  • upset stomach

Serious side effects

Provigil and Nuvigil also have many possible serious side effects in common, such as:

  • severe rash
  • serious allergic reaction
  • mental health effects, such as anxiety, depression, and confusion
  • heart effects, with symptoms such as chest pain, palpitations, and trouble breathing


Provigil and Nuvigil are considered first-choice medication options for decreasing sleepiness in people with narcolepsy, sleep apnea, and shift work sleep disorder. However, their effectiveness hasn’t been directly compared in clinical studies.

That said, an analysis of clinical studies indicates that Provigil and Nuvigil might work about equally well for reducing sleepiness for people with sleep apnea.


Provigil and Nuvigil are both brand-name drugs. They’re also both available in generic forms. The generic name of Nuvigil is armodafinil. Generic drugs are typically less expensive than brand-name drugs.

The brand and generic versions of Provigil appear to be more expensive than the brand and generic versions of Nuvigil. Whichever drug you take, the amount you pay will depend on your health insurance plan.

You may wonder how Provigil compares to certain drugs such as Vyvanse. Provigil and Vyvanse (lisdexamfetamine) are both stimulant medications, but they affect the brain in slightly different ways.

Provigil increases wakefulness and alertness. Vyvanse can cause wakefulness and, in people with attention deficit hyperactivity disorder (ADHD), can also produce feelings of calm and focus.


Provigil is FDA-approved for treating daytime sleepiness caused by narcolepsy, sleep apnea, and shift work sleep disorder. Vyvanse is used off-label for these uses.

Vyvanse is FDA-approved for treating ADHD. It’s also approved for treating binge eating disorder. Provigil is used off-label for these uses.

Drug forms

Provigil is available as an oral tablet that’s usually taken once daily. Vyvanse is available as a capsule and a chewable tablet, each of which is taken once daily.

Side effects and risks

Provigil and Vyvanse are both stimulant medications. As a result, they have several similar side effects.

Provigil and VyvanseProvigilVyvanse
More common side effects
  • nausea
  • vomiting
  • anxiety
  • trouble sleeping
  • loss of appetite
  • diarrhea
  • upset stomach
  • dry mouth
  • dizziness
  • weakness
  • lack of coordination
  • confusion
  • fatigue
(few unique common side effects)
Serious side effects
  • serious allergic reaction
  • mental health effects such as anxiety or depression
  • heart effects such as chest pain or palpitations
  • physical and psychological dependence*
  • misuse and abuse*
  • a serious, sometimes life-threatening, rash
  • withdrawal symptoms when the medication is stopped

*This risk may be higher with Vyvanse than with Provigil.


The purposes that both Provigil and Vyvanse are used for are:

  • treating ADHD
  • decreasing daytime sleepiness in people with narcolepsy or other disorders

For the treatment of ADHD, these medications have not been directly compared in clinical studies. However, according to an analysis of clinical studies, Vyvanse appears to be more effective than Provigil for treating ADHD in adults.

These medications have also not been directly compared in clinical studies looking at decreasing daytime sleepiness in people with narcolepsy or other disorders. However, it’s important to note that Provigil is a first-choice medication for this use, while Vyvanse is an alternative treatment choice.


Provigil and Vyvanse are brand-name drugs. Provigil is also available in a generic form called modafinil, but Vyvanse is not available as a generic. Generic drugs are typically less expensive than brand-name drugs.

Provigil costs more than Vyvanse. However, the generic version of Provigil costs less than Vyvanse. The actual amount you pay will depend on your health insurance plan.

How Provigil works to help increase wakefulness and decrease sleepiness isn’t clear. The drug works in the brain to increase amounts of certain chemical messengers such as dopamine. It also seems to affect the messenger glutamate in certain areas of the brain.

These actions may result in stimulation of brain activities, which could make you feel less tired.

How long does it take to work?

Provigil begins to work within 30 to 60 minutes of when you take it. If you take it with food, the drug might take slightly longer to start working.

There haven’t been enough studies done in humans to be sure how this drug might affect a fetus. Some research in animals has shown negative effects to a fetus when the mother takes this drug. However, animal studies don’t always predict the way humans would respond.

Slowed growth of the fetus and spontaneous abortion have occurred in women who took Provigil. However, it’s not clear if Provigil was the cause.

Talk to your doctor if you’re pregnant or planning to become pregnant. This medication should only be used during pregnancy if the benefit justifies the potential risk.

If you do take Provigil while pregnant, you can sign up for a registry that will help gather information about your experience. Pregnancy exposure registries help healthcare professionals learn more about how certain drugs affect women and their pregnancies. To sign up, call 1-866-404-4106.

It’s not known if Provigil passes through breast milk.

If you’re breastfeeding your child, talk to your doctor. You may need to decide whether to stop breastfeeding or stop taking this medication.

Here are answers to some frequently asked questions about Provigil.

Is Provigil a stimulant?

Yes, Provigil is a stimulant.

How long does it take to work?

For most people, it usually takes 30 to 60 minutes to start working. If you take Provigil with food, it might take slightly longer.

What is the difference between Modalert and Provigil?

Modalert is another name for Provigil. This form of Provigil is sold in countries outside of North America. Modalert isn’t sold in the United States.

What if Provigil stops working?

For most people who take Provigil as prescribed by their doctor, it continues to work even when taken for long periods of time.

However, if you feel that it’s no longer working for you, talk to your doctor. They may need to increase your dosage or consider a different medication.

Taking too much of this medication can increase your risk of severe side effects.

Overdose symptoms

Symptoms of overdose of Provigil can include:

  • irritability
  • anxiety
  • agitation
  • confusion
  • nervousness
  • trouble sleeping
  • nausea
  • vomiting
  • diarrhea
  • hallucinations
  • increased blood pressure
  • rapid heartbeat
  • chest pain

What to do in case of overdose

If you think you or your child has taken too much of this drug, call your doctor or seek guidance from the American Association of Poison Control Centers at 1-800-222-1222 or through their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

When Provigil is dispensed from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically one year from the date the medication was dispensed.

These dates are set to guarantee the effectiveness of the medication during this time.

The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. However, an FDA study showed that many medications may still be good beyond the expiration date listed on the bottle.

How long a medication remains good can depend on many factors, including how and where the medication is stored. Provigil should be stored at room temperature.

If you have unused medication that has gone past the expiration date, talk to your pharmacist about whether you might still be able to use it.

Before taking Provigil, talk with your doctor about your health history. Provigil may not be right for you if you have certain medical conditions. These include:

  • Mental health conditions. Provigil can sometimes cause mental health side effects such as depression, mania, or psychosis. If you’ve had a mental health condition in the past, you may be at higher risk for getting these side effects.
  • Heart conditions. Provigil can cause some side effects to the heart such as fast heartbeat, increased blood pressure, and chest pain. If you have a heart condition, your doctor may want to monitor your heart before or during treatment with this drug.

The following information is provided for clinicians and other healthcare professionals.

Mechanism of action

Provigil is a stimulant with effects dissimilar compared to other central nervous stimulants such as amphetamine or methylphenidate. Provigil does not have alpha-adrenergic effects, but the alpha-adrenergic antagonist prazosin can decrease the wakefulness effects of Provigil.

Provigil dopamine reuptake does not have dopamine receptor agonist activity. Dopamine antagonists do not block wakefulness from Provigil.

Animal studies show that Provigil increases glutaminergic activity in the thalamus and hippocampus.

Pharmacokinetics and metabolism

Provigil is readily absorbed when taken orally and reaches peak plasma concentration within 2 to 4 hours. Peak levels may be delayed by about an hour when the drug is taken with food.

Provigil is primarily eliminated via the liver. Provigil induces cytochrome P450 3A4 and induces its own metabolism through this route.

Elimination of Provigil is decreased by about 60 percent in people with severe liver disease.

The half-life of Provigil is about 15 hours.


Provigil is contraindicated in people who have had a hypersensitivity reaction to Provigil or Nuvigil (armodafinil) in the past.

Abuse and dependence

Provigil is a Schedule IV controlled substance. Studies show that Provigil has the potential to cause euphoric effects and feelings consistent with other stimulants, including methylphenidate. People with a history of alcohol or drug abuse may have a higher risk of abusing Provigil.

Although drug dependence may occur, withdrawal symptoms have not been identified.


Provigil should be stored at room temperature: 68°F to 77°F (20°C to 25°C).

Disclaimer: MedicalNewsToday has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

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