Side Effects, Dosage, Uses & More

Highlights for benzonatate

1. Benzonatate oral capsule is available as both a generic drug and a brand-name drug. Brand name: Tessalon.
2. Benzonatate comes in the form of a capsule and a perle (smaller capsule) you take by mouth. This medication needs to be swallowed whole. You shouldn’t break, chew, cut, or crush this drug.
3. This drug is used to relieve coughing. It starts working about 15–20 minutes after you swallow it. Its effects last for 3–8 hours.

• Allergic reactions: This drug needs to be swallowed whole. People who chew or suck the capsule are at higher risk for allergic reactions. This may cause spasms of your bronchi (the main passageway into your throat and airways) and vocal cords. It may also cause negative effects on your heart and blood vessels.
• Psychiatric problems: This drug may cause confusion and visual hallucinations (seeing something that isn’t there). This serious side effect has only been seen in people who were also taking other medications.
• Overdose in children: Accidentally swallowing this drug could be fatal (cause death) in children younger than 10 years old. The symptoms of overdose can appear 15–20 minutes after swallowing the capsule, and death can happen in about one hour. If your child swallows this drug, call your doctor or seek medical help right away.

Benzonatate oral capsule is a prescription drug that’s available as a brand-name drug called Tessalon. It’s also available as a generic drug. Generic drugs usually cost less. In some cases, they may not be available in every strength or form as the brand-name version.

Benzonatate also comes as an oral perle (smaller capsule).

Why it’s used

Benzonatate is used to relieve coughing. It starts working about 15–20 minutes after you swallow it. Its effects last for 3–8 hours.

Benzonatate may be used as part of a combination therapy. This means you may need to take it with other medications.

How it works

Benzonatate belongs to a class of drugs called antitussive agents. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

Benzonatate works by numbing the receptors in your airways that cause you to cough. This makes you cough less after taking the drug.

Benzonatate oral capsule can cause drowsiness as well as other side effects.

More common side effects

The more common side effects of benzonatate oral capsule include:

• drowsiness
• dizziness
• headaches
• constipation
• nausea
• upset stomach
• breakouts
• nasal congestion

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious side effects

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:

• allergic reactions, symptoms can include:
  • trouble breathing
  • swelling or tightness in your throat
  • heart and blood vessel problems, such as very low blood pressure. This may cause you to feel dizzy or faint.
• confusion
• hallucinations (seeing or hearing something that isn’t there)
• chest numbness
• burning of your eyes

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.

An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well. To help prevent interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking.

To find out how benzonatate oral capsule might interact with something else you’re taking, talk to your doctor or pharmacist.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.

This drug comes with several warnings.

Numbness

Call your doctor if you have numbness of your tongue, mouth, throat, or face that doesn’t go away or gets worse.

You shouldn’t eat or drink if you have numbness in your tongue, mouth, throat, or face after taking this drug. Once the numbness goes away, you can eat and drink.

Allergies

Benzonatate can cause a severe allergic reaction. Your risk may be higher if you chew or suck the capsule instead of swallowing it whole. Symptoms can include:

• trouble breathing
• swelling or tightness in your throat
• heart and blood vessel problems, such as very low blood pressure. This may cause you to feel dizzy or faint.

If you have an allergic reaction, call your doctor or local poison control center right away. If your symptoms are severe, call 911 or go to the nearest emergency room. Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal (cause death).

Warnings for certain groups

For pregnant women: Benzonatate is a category C pregnancy drug. That means two things:

1. Research in animals has shown adverse effects to the fetus when the mother takes the drug.
2. There haven’t been enough studies done in humans to be certain how the drug might affect the fetus.

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

Call your doctor right away if you become pregnant while taking this drug.

Women who are breastfeeding: Benzonatate may pass into breast milk and may cause side effects in a child who is breastfed. Talk to your doctor if you breastfeed your child. You may need to decide whether to stop breastfeeding or stop taking this medication.

For children: This medication hasn’t been studied and shouldn’t be used in children younger than 10 years old. Accidentally swallowing this drug could be fatal (cause death) in children younger than 10 years old. Keep this drug away from young children.

This dosage information is for benzonatate oral capsule. All possible dosages and drug forms may not be included here. Your dosage, drug form, and how often you take the drug will depend on:

• your age
• the condition being treated
• how severe your condition is
• other medical conditions you have
• how you react to the first dose

Forms and strengths

Generic: Benzonatate

• Form: oral capsule
• Strengths: 100 mg, 150 mg, 200 mg

Brand: Tessalon

• Form: oral capsule
• Strengths: 200 mg

Dosage to relieve coughing

Adult dosage (ages 18 years and older)

Take 100–200 mg three times per day as needed for your cough. The maximum dosage is 600 mg per day.

Child dosage (ages 11 to 17 years)

Take 100–200 mg three times per day as needed for your cough. The maximum dosage is 600 mg per day.

Child dosage (ages 0 to 10 years)

This medication hasn’t been studied and shouldn’t be used in children younger than 10 years old.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always speak with your doctor or pharmacist about dosages that are right for you.

Benzonatate oral capsule is typically used for short-term treatment. It comes with risks if you don’t take it as prescribed.

If you don’t take it at all: Your coughing will continue.

If you take too much: You could have dangerous levels of the drug in your body. Your risk may be higher if you chew or suck this drug instead of swallowing it whole. Symptoms can appear as soon as 15 to 20 minutes after taking too much. Symptoms of an overdose include:

• choking
• breathing problems
• feeling restless
• shakiness
• seizures
• brain swelling
• stopping of your heart
• coma (being unconscious for a long time)
• death

If you think you’ve taken too much of this drug, call your doctor or local poison control center. If your symptoms are severe, call 911 or go to the nearest emergency room right away.

How to tell if the drug is working: You shouldn’t cough as much. This drug starts working about 15 to 20 minutes after you swallow it. Its effects last for 3 to 8 hours.

Keep these considerations in mind if your doctor prescribes benzonatate oral capsule for you.

General

• You can take benzonatate with or without food.
• You should swallow this drug whole. Don’t break, chew, cut, or crush this medication.
• Not every pharmacy stocks this drug. When filling your prescription, be sure to call ahead to make sure your pharmacy carries it.

Storage

• Store benzonatate at room temperature between 59°F and 86°F (15°C and 30°C). Keep it as close to 77°F (25°C) as you can.
• Keep this drug away from light.
• Don’t store this medication in moist or damp areas, such as bathrooms.

Refills

A prescription for this medication is refillable. You should not need a new prescription for this medication to be refilled. Your doctor will write the number of refills authorized on your prescription.

Travel

When traveling with your medication:

• Always carry your medication with you. When flying, never put it into a checked bag. Keep it in your carry-on bag.
• Don’t worry about airport X-ray machines. They can’t hurt your medication.
• You may need to show airport staff the pharmacy label for your medication. Always carry the original prescription-labeled box with you.
• Don’t put this medication in your car’s glove compartment or leave it in the car. Be sure to avoid doing this when the weather is very hot or very cold.

Clinical monitoring

You and your doctor should monitor certain health issues. This can help make sure you stay safe while you take this drug. These issues include:

• Cough. Call your doctor if your cough isn’t getting better.

There are other drugs available to treat your condition. Some may be better suited for you than others. Talk to your doctor about other drug options that may work for you.

Disclaimer: Healthline 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.

Side Effects, Dosage, Uses & More

Highlights for benzonatate

1. Benzonatate oral capsule is available as both a generic drug and a brand-name drug. Brand name: Tessalon.
2. Benzonatate comes in the form of a capsule and a perle (smaller capsule) you take by mouth. This medication needs to be swallowed whole. You shouldn’t break, chew, cut, or crush this drug.
3. This drug is used to relieve coughing. It starts working about 15–20 minutes after you swallow it. Its effects last for 3–8 hours.

• Allergic reactions: This drug needs to be swallowed whole. People who chew or suck the capsule are at higher risk for allergic reactions. This may cause spasms of your bronchi (the main passageway into your throat and airways) and vocal cords. It may also cause negative effects on your heart and blood vessels.
• Psychiatric problems: This drug may cause confusion and visual hallucinations (seeing something that isn’t there). This serious side effect has only been seen in people who were also taking other medications.
• Overdose in children: Accidentally swallowing this drug could be fatal (cause death) in children younger than 10 years old. The symptoms of overdose can appear 15–20 minutes after swallowing the capsule, and death can happen in about one hour. If your child swallows this drug, call your doctor or seek medical help right away.

Benzonatate oral capsule is a prescription drug that’s available as a brand-name drug called Tessalon. It’s also available as a generic drug. Generic drugs usually cost less. In some cases, they may not be available in every strength or form as the brand-name version.

Benzonatate also comes as an oral perle (smaller capsule).

Why it’s used

Benzonatate is used to relieve coughing. It starts working about 15–20 minutes after you swallow it. Its effects last for 3–8 hours.

Benzonatate may be used as part of a combination therapy. This means you may need to take it with other medications.

How it works

Benzonatate belongs to a class of drugs called antitussive agents. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

Benzonatate works by numbing the receptors in your airways that cause you to cough. This makes you cough less after taking the drug.

Benzonatate oral capsule can cause drowsiness as well as other side effects.

More common side effects

The more common side effects of benzonatate oral capsule include:

• drowsiness
• dizziness
• headaches
• constipation
• nausea
• upset stomach
• breakouts
• nasal congestion

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious side effects

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:

• allergic reactions, symptoms can include:
  • trouble breathing
  • swelling or tightness in your throat
  • heart and blood vessel problems, such as very low blood pressure. This may cause you to feel dizzy or faint.
• confusion
• hallucinations (seeing or hearing something that isn’t there)
• chest numbness
• burning of your eyes

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.

An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well. To help prevent interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking.

To find out how benzonatate oral capsule might interact with something else you’re taking, talk to your doctor or pharmacist.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.

This drug comes with several warnings.

Numbness

Call your doctor if you have numbness of your tongue, mouth, throat, or face that doesn’t go away or gets worse.

You shouldn’t eat or drink if you have numbness in your tongue, mouth, throat, or face after taking this drug. Once the numbness goes away, you can eat and drink.

Allergies

Benzonatate can cause a severe allergic reaction. Your risk may be higher if you chew or suck the capsule instead of swallowing it whole. Symptoms can include:

• trouble breathing
• swelling or tightness in your throat
• heart and blood vessel problems, such as very low blood pressure. This may cause you to feel dizzy or faint.

If you have an allergic reaction, call your doctor or local poison control center right away. If your symptoms are severe, call 911 or go to the nearest emergency room. Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal (cause death).

Warnings for certain groups

For pregnant women: Benzonatate is a category C pregnancy drug. That means two things:

1. Research in animals has shown adverse effects to the fetus when the mother takes the drug.
2. There haven’t been enough studies done in humans to be certain how the drug might affect the fetus.

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

Call your doctor right away if you become pregnant while taking this drug.

Women who are breastfeeding: Benzonatate may pass into breast milk and may cause side effects in a child who is breastfed. Talk to your doctor if you breastfeed your child. You may need to decide whether to stop breastfeeding or stop taking this medication.

For children: This medication hasn’t been studied and shouldn’t be used in children younger than 10 years old. Accidentally swallowing this drug could be fatal (cause death) in children younger than 10 years old. Keep this drug away from young children.

This dosage information is for benzonatate oral capsule. All possible dosages and drug forms may not be included here. Your dosage, drug form, and how often you take the drug will depend on:

• your age
• the condition being treated
• how severe your condition is
• other medical conditions you have
• how you react to the first dose

Forms and strengths

Generic: Benzonatate

• Form: oral capsule
• Strengths: 100 mg, 150 mg, 200 mg

Brand: Tessalon

• Form: oral capsule
• Strengths: 200 mg

Dosage to relieve coughing

Adult dosage (ages 18 years and older)

Take 100–200 mg three times per day as needed for your cough. The maximum dosage is 600 mg per day.

Child dosage (ages 11 to 17 years)

Take 100–200 mg three times per day as needed for your cough. The maximum dosage is 600 mg per day.

Child dosage (ages 0 to 10 years)

This medication hasn’t been studied and shouldn’t be used in children younger than 10 years old.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always speak with your doctor or pharmacist about dosages that are right for you.

Benzonatate oral capsule is typically used for short-term treatment. It comes with risks if you don’t take it as prescribed.

If you don’t take it at all: Your coughing will continue.

If you take too much: You could have dangerous levels of the drug in your body. Your risk may be higher if you chew or suck this drug instead of swallowing it whole. Symptoms can appear as soon as 15 to 20 minutes after taking too much. Symptoms of an overdose include:

• choking
• breathing problems
• feeling restless
• shakiness
• seizures
• brain swelling
• stopping of your heart
• coma (being unconscious for a long time)
• death

If you think you’ve taken too much of this drug, call your doctor or local poison control center. If your symptoms are severe, call 911 or go to the nearest emergency room right away.

How to tell if the drug is working: You shouldn’t cough as much. This drug starts working about 15 to 20 minutes after you swallow it. Its effects last for 3 to 8 hours.

Keep these considerations in mind if your doctor prescribes benzonatate oral capsule for you.

General

• You can take benzonatate with or without food.
• You should swallow this drug whole. Don’t break, chew, cut, or crush this medication.
• Not every pharmacy stocks this drug. When filling your prescription, be sure to call ahead to make sure your pharmacy carries it.

Storage

• Store benzonatate at room temperature between 59°F and 86°F (15°C and 30°C). Keep it as close to 77°F (25°C) as you can.
• Keep this drug away from light.
• Don’t store this medication in moist or damp areas, such as bathrooms.

Refills

A prescription for this medication is refillable. You should not need a new prescription for this medication to be refilled. Your doctor will write the number of refills authorized on your prescription.

Travel

When traveling with your medication:

• Always carry your medication with you. When flying, never put it into a checked bag. Keep it in your carry-on bag.
• Don’t worry about airport X-ray machines. They can’t hurt your medication.
• You may need to show airport staff the pharmacy label for your medication. Always carry the original prescription-labeled box with you.
• Don’t put this medication in your car’s glove compartment or leave it in the car. Be sure to avoid doing this when the weather is very hot or very cold.

Clinical monitoring

You and your doctor should monitor certain health issues. This can help make sure you stay safe while you take this drug. These issues include:

• Cough. Call your doctor if your cough isn’t getting better.

There are other drugs available to treat your condition. Some may be better suited for you than others. Talk to your doctor about other drug options that may work for you.

Disclaimer: Healthline 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.

Benzonatate Capsules: Uses, Images and Side Effects

• Generic Name: Benzonatate Capsules
• Brand Name: Benzonatate

• Concomitant Drugs Triacin C Tussigon
• Health Resources Chronic Cough, Cold
• Related Supplements Andrographis Echinacea Zinc

• Images and side effects
• How to take
• Avoid

Information for patients with benzonatate, including side effects

Brand names: Tessalon, Tessalon Perles, Zonatuss

Generic name: benzonatate

• What is benzonatate (Tessalon, Tessalon Perles, Zonatuss) ?
• What are the possible side effects of benzonatate (Tessalon, Tessalon Perles, Zonatuss)?
• What is the most important information I should know about benzonatate (Tessalon, Tessalon Perles, Zonatuss)?
• What should I discuss with my doctor before taking benzonatate (Tessalon, Tessalon Perles, Zonatuss)?
• How do I take benzonatate (Tessalon, Tessalon Perles, Zonatuss)?
• What happens if I miss a dose (Tessalon, Tessalon Perles, Zonatuss)?
• What happens if I overdose (Tessalon, Tessalon Perles, Zonatuss)?
• What should I avoid while taking benzonatate (Tessalon, Tessalon Perles, Zonatuss)?
• What other drugs will affect benzonatate (Tessalon, Tessalon Perles, Zonatuss)?
• Where can I get more information (Tessalon, Tessalon Perles, Zonatuss)?

What is benzonatate (Tessalon, Tessalon Perles, Zonatuss)?

Benzonatate is used to relieve cough.

Benzonatate is a non-narcotic cough medicine that numbs the throat and lungs by reducing the activity of the cough reflex.

Benzonatate may also be used for purposes not listed in this medication guide.

What are the possible side effects of benzonatate (Tessalon, Tessalon Perles, Zonatuss)?

Stop taking this medicine and get emergency medical help if you have signs of an allergic reaction : hives; labored breathing; swelling of the face, lips, tongue, or throat.

Call your doctor right away if you have:

• severe drowsiness or dizziness;
• confusion, hallucinations.
• persistent numbness or tingling in the mouth, throat or face;
• numbness in chest;
• to panting feeling;
• chills; or
• burning sensation in the eyes.

Some of these side effects may result from chewing or sucking the benzonatate capsule.

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Common side effects may include:

• headache, dizziness;
• nausea, indigestion;
• constipation;
• itching, rash; or
• nasal congestion.

This is not a complete list of side effects and they may occur. Ask your doctor about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

What is the most important information I should know about benzonatate (Tessalon, Tessalon Perles, Zonatuss)?

Never suck or chew a benzonatate capsule. Swallow the tablet whole. Sucking or chewing a capsule may cause serious side effects.

Benzonatate is not approved for use by anyone under 10 years of age. An overdose of benzonatate can be fatal to a young child.

Information for patients with benzonatate, including how I should take it

What should I discuss with my doctor before taking benzonatate (Tessalon, Tessalon Perles, Zonatuss)?

You should not use this medicine if you are allergic to benzonatate or local pain relievers such as tetracaine or procaine (found in insect bite and sunburn creams).

Tell your doctor if you are pregnant or breastfeeding.

Benzonatate is not approved for use by anyone under 10 years of age. An overdose of benzonatate can be fatal, especially for a small child who accidentally swallows the medicine.

How do I take benzonatate (Tessalon, Tessalon Perles, Zonatuss)?

Follow all directions on your prescription label and read any medication guides or instructions. Use the medicine exactly as directed.

Never suck or chew a benzonatate capsule. Swallow the tablet whole. Sucking or chewing a capsule may cause serious side effects.

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Store at room temperature away from moisture, heat and light.

Information for patients with benzonatate, including the missed dose

What happens if I miss a dose (Tessalon, Tessalon Perles, Zonatuss)?

Skip the missed dose and use the next dose at the usual time. Do not use two doses at a time.

What happens if I overdose (Tessalon, Tessalon Perles, Zonatuss)?

Seek emergency medical attention or call the Poison Helpline at 1-800-222-1222. An overdose of benzonatate can be fatal, especially to a child. Accidental death occurred in children under 10 years of age.

Overdose symptoms may include tremors, restlessness, convulsions (convulsions), slow heartbeat, weak pulse, fainting, and slow breathing (breathing may stop).

What should I avoid while taking benzonatate (Tessalon, Tessalon Perles, Zonatuss)?

Do not eat or drink anything if you feel numbness or tingling in your mouth or throat.

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What other drugs will affect benzonatate (Tessalon, Tessalon Perles, Zonatuss)?

The use of benzonatate with other drugs that cause drowsiness may worsen this effect. Ask your doctor before taking opioids, sleeping pills, muscle relaxers, or medications for anxiety or seizures.

Other drugs may affect benzonatate, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medications and any medications you start or stop using.

Where can I get more information (Tessalon, Tessalon Perles, Zonatuss)?

Your pharmacist can provide more information about benzonatate.

Remember, keep this and all other medicines out of the reach of children, never give your medicines to others, and use this medicine only as directed. Every effort has been made to ensure that the information provided by Cerner Multum, Inc. is accurate, current and complete. (“Multum”), but no guarantees are given in this regard. The information contained herein about the drug may vary over time. Multum’s information has been collected for use by clinicians and consumers in the United States, and therefore Multum does not warrant that use outside of the United States is appropriate unless specifically stated otherwise. Multum’s drug information does not contain recommendations for drugs, patient diagnosis, or treatment. Multum Drug Information is an information resource designed to assist licensed practitioners in caring for their patients and/or serving consumers who view this service as an addition to, and not a substitute for, the experience, skills, knowledge, and judgment of practitioners. The absence of a warning for a given drug or drug combination should in no way be construed as an indication that the drug or drug combination is safe, effective or suitable for any given patient. Multum assumes no responsibility for any aspects of health care managed by the information provided by Multum. The information contained in this document is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or side effects. If you have any questions about the medicines you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2021 Cerner Multum, Inc.

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Adult Medication

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This document, provided by Lexicomp ^® , contains all the information you need to know about this medicine, including indications, directions for use, side effects, and when your healthcare provider should be contacted.

Trade names: USA

Tessalon Perles [DSC]

What is this drug used for?

• Used to relieve cough.

What should I tell my doctor BEFORE taking this drug?

• If you have an allergy to this drug, any of its ingredients, other drugs, foods or substances. Tell your doctor about your allergies and how they have manifested.

Combining this drug with certain drugs and conditions may be unfavorable.

Tell your doctor and pharmacist about all medicines you take (both prescription and over-the-counter, natural medicines and vitamins) and any health problems you have. You need to make sure that this drug is safe for your conditions and in combination with other drugs you are already taking. Do not start or stop taking any drug or change the dosage without your doctor’s advice.

What do I need to know or do while taking this drug?

• Tell all your health care workers that you are taking this drug. These are doctors, nurses, pharmacists and dentists.
• Avoid driving and other activities that require increased attention until you see how this drug affects you.
• Keep out of the reach of children. Cases of unintentional overdose and death have been reported among children under the age of 10 years who took the drug by accident. Overdose may be manifested by anxiety, tremors, convulsions, loss of consciousness, or the development of myocardial infarction. If this drug is accidentally taken by a child, seek medical attention immediately.
• Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding. The benefits and risks for you and your child will need to be discussed.

What side effects should I report to my doctor immediately?

WARNING. In rare cases, this drug can cause serious and sometimes deadly side effects in some patients. Call your doctor right away or get medical help if you have any of the following signs or symptoms that could be associated with serious side effects:

• Signs of an allergic reaction, such as rash, hives, itching, red and swollen skin with blisters or peeling, possibly accompanied by fever, wheezing or wheezing, tightness in the chest or throat, difficulty breathing, swallowing or speaking, unusual hoarseness, swelling in the mouth, face, lips, tongue or throat.
• Changes in behavior.
• Confusion of consciousness.
• Hallucinations (a person sees or hears something that is not in reality).
• When breaking, grinding, chewing, dissolving in the mouth or resorption of the drug, there were cases of numbness or tingling in the mouth, tongue, pharynx and face. Choking and very severe allergic reactions have also occurred. If you experience a feeling of numbness or tingling, do not eat or drink until the feeling has passed. If you develop an allergic reaction, or if the numbness or tingling persists or gets worse, seek medical attention immediately.

What are some other side effects of this drug?

Any medicine can have side effects. However, for many people, side effects are either minor or non-existent. Contact your doctor or seek medical attention if these or any other side effects bother you or do not go away:

• Constipation.
• Dizziness or headache.
• Drowsiness.
• Stuffy nose.
• Nausea.

This list of possible side effects is not exhaustive. If you have any questions about side effects, please contact your doctor. Talk to your doctor about side effects.

You can report side effects to the National Health Board.

You can report side effects to the FDA at 1-800-332-1088. You can also report side effects at https://www.fda.gov/medwatch.

What is the best way to take this drug?

Use this drug as directed by your doctor. Read all the information provided to you. Strictly follow all instructions.

• Swallow whole. Do not chew, break, open or dissolve.
• Do not suck this drug.
• Drink plenty of non-caffeinated fluids, unless your doctor has told you to drink less fluids.

What should I do if I miss a dose of a drug?

• If you are taking the drug regularly, take the missed dose as soon as you can.
• If it’s time for your next dose, don’t take the missed dose and then go back to your regular dosing schedule.
• Do not take 2 doses or an additional dose at the same time.
• In most cases, this drug is used as needed. Do not take the drug more often than prescribed by your doctor.

How do I store and/or discard this drug?

• Store at room temperature, protected from light. Store in a dry place. Do not store in the bathroom.
• Keep all medicines in a safe place. Keep all medicines out of the reach of children and pets.
• Dispose of unused or expired drugs. Do not empty into a toilet or sewer unless instructed to do so. If you have any questions about disposing of medicines, ask your pharmacist. Drug disposal programs may be in place in your area.

General information about medicines

• If your health does not improve or even worsens, see your doctor.
• Do not give your medicine to anyone and do not take other people’s medicines.
• Some medicines may come with other patient information leaflets. If you have questions about this drug, talk with your doctor, nurse, pharmacist, or other health care professional.
• Some medicines may come with other patient information leaflets. Check with your pharmacist. If you have questions about this drug, talk with your doctor, nurse, pharmacist, or other health care professional.
• If you think you have overdosed, call a poison control center or get medical help right away. Be prepared to tell or show what drug you took, how much, and when it happened.

Consumer Use of Information and Limitation of Liability

This summary information includes a summary of the diagnosis, treatment, and/or drug product. It is not intended to be a comprehensive source of data and should be used as a tool to help the user understand and/or evaluate potential diagnostic and treatment options. It does NOT include all information about conditions, treatments, medications, side effects, or risks that may apply to a particular patient. It should not be considered medical advice or a substitute for medical advice, diagnosis or treatment provided by a physician based on a medical examination and assessment of the patient’s specific and unique circumstances. Patients should consult with their physician for full information about their health, medical issues, and treatment options, including any risks or benefits regarding the use of medications.