Tessalon Perles Oral

This section provides information on the proper use of a number of products that contain cough and cold combinations. It may not be specific to Tessalon Perles. Please read with care.

To help loosen mucus or phlegm in the lungs, drink a glass of water after each dose of this medicine, unless otherwise directed by your doctor.

Take this medicine only as directed. Do not take more of it and do not take it more often than recommended on the label, unless otherwise directed by your doctor. To do so may increase the chance of side effects.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

For patients taking the extended-release capsule or tablet form of this medicine:

• Swallow the capsule or tablet whole.
• Do not crush, break, or chew before swallowing.
• If the capsule is too large to swallow, you may mix the contents of the capsule with applesauce, jelly, honey, or syrup and swallow without chewing.

For patients taking the extended-release oral solution or oral suspension form of this medicine:

• Do not dilute with fluids or mix with other drugs.

For patients taking a combination medicine containing an antihistamine and/or aspirin or other salicylate:

• Take with food or a glass of water or milk to lessen stomach irritation, if necessary.

If a combination medicine containing aspirin has a strong vinegar-like odor, do not use it. This odor means the medicine is breaking down. If you have any questions about this, check with your pharmacist.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Keep the liquid form of this medicine from freezing. Do not refrigerate the syrup.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Although serious side effects occur rarely when this medicine is taken as recommended, they may be more likely to occur if: too much medicine is taken, it is taken in large doses, or it is taken for a long period of time.

Get emergency help immediately if any of the following symptoms of overdose occur:

If you are a nursing mother and you notice any of the following symptoms of overdose in your baby, get emergency help immediately:

• Cold, clammy skin
• confusion (severe)
• convulsions (seizures)
• drowsiness or dizziness (severe)
• nervousness or restlessness (severe)
• pinpoint pupils of eyes
• slow heartbeat
• slow or troubled breathing
• Difficulty breathing
• difficulty nursing
• increased sleepiness (more than usual)
• limpness

• Diarrhea
• increased sweating
• loss of appetite
• nausea or vomiting
• stomach cramps or pain
• swelling or tenderness in the upper abdomen or stomach area

• Any loss of hearing
• bloody urine
• confusion
• convulsions (seizures)
• dizziness or lightheadedness
• drowsiness (severe)
• excitement or nervousness (severe)
• fast or deep breathing
• fever
• hallucinations (seeing, hearing, or feeling things that are not there)
• increased sweating
• nausea or vomiting (severe or continuing)
• shortness of breath or troubled breathing (for salicylamide only)
• stomach pain (severe or continuing)
• uncontrollable flapping movements of the hands, especially in elderly patients
• unusual thirst
• vision problems

• Fast, pounding, or irregular heartbeat
• headache (continuing and severe)
• nausea or vomiting (severe)
• nervousness or restlessness (severe)
• shortness of breath or troubled breathing (severe or continuing)

Check with your doctor as soon as possible if any of the following side effects occur:

• Skin rash, hives, and/or itching

• Clumsiness or unsteadiness
• convulsions (seizures
• drowsiness (severe)
• dryness of mouth, nose, or throat (severe)
• flushing or redness of face
• hallucinations (seeing, hearing, or feeling things that are not there)
• restlessness (severe)
• shortness of breath or troubled breathing
• slow or fast heartbeat

• Headache (continuing)
• increased watering of mouth
• loss of appetite
• metallic taste
• skin rash, hives, or redness
• sore throat
• swelling of face, lips, or eyelids

• Unexplained sore throat and fever
• unusual tiredness or weakness
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Constipation
• decreased sweating
• difficult or painful urination
• dizziness or lightheadedness
• drowsiness
• dryness of mouth, nose, or throat
• false sense of well-being
• increased sensitivity of skin to sun
• nausea or vomiting
• nightmares
• stomach pain
• thickening of mucus
• trouble in sleeping
• unusual excitement, nervousness, restlessness, or irritability
• unusual tiredness or weakness

Not all of the side effects listed above have been reported for each of these medicines, but they have been reported for at least one of them. There are some similarities among these combination medicines, so many of the above side effects may occur with any of these medicines.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

This medication is used to treat coughs caused by the common cold and other breathing problems (e.g., pneumonia, bronchitis, emphysema, asthma). It works by reducing the reflex in the lungs that causes the urge to cough.

Use of this medication is not recommended in children younger than 10 years. Discuss the risks and benefits with your doctor.

How to use Tessalon PERLE

Take this medication by mouth with or without food, usually 3 times daily as needed or as directed by your doctor.

Swallow this medication whole. Do not chew, suck, or dissolve this medication in your mouth. Doing so will cause a loss of feeling in your mouth/throat and may cause choking or a severe allergic reaction. (See also Side Effects section.) Do not eat or drink until the numbness goes away. Get medical help right away if the numbness persists or worsens.

Dosage is based on your medical condition and response to therapy. Do not take more than 200 milligrams at one time. Taking more benzonatate than prescribed will not make your cough go away faster but may result in serious side effects.

Tell your doctor if your condition persists or worsens.

Before taking benzonatate, tell your doctor or pharmacist if you are allergic to it; or to certain anesthetic agents (e.g., procaine, tetracaine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, or if a child accidentally swallows this medication, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: restlessness, shaking (tremors), seizures, inability to wake up (coma).

Notes

Do not share this medication with others.

Missed Dose

If you miss a dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Always store benzonatate in a child-resistant container. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.Information last revised March 2017. Copyright(c) 2017 First Databank, Inc.