Tessalon

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Keep this medication in the container it came in, tightly closed. It is very important to store this medication in a closed child-proof container and to keep it out of reach of children. Children may be attracted to the shape and look of the liquid-filled capsules and may die if they swallow the medication. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Benzonatate comes in 100 milligram (mg) and 200 mg capsules, and is taken up to a maximum of three times a day, depending on your prescription. Taking more benzonatate than you are prescribed can be very dangerous.

Always take benzonatate with a full glass of water and swallow the capsule whole. You should never chew, suck, or crush the capsule.

If your doctor prescribed the 200 mg dose and you have trouble swallowing large capsules, try taking two of the 100 mg capsules instead one of the 200 mg ones. You will need to tell your doctor or pharmacist ahead of time to get the right dosage size.

Children under the age of 10 should not take benzonatate.

Overdose of Benzonatate

Deliberate and accidental overdoses of benzonatate can kill adults or children rapidly. Children are especially at risk, even at low doses.

You must get emergency medical help and call a poison-control center as soon as you suspect an overdose. You can reach a poison-control center at (800) 222-1222.

Symptoms of an overdose may start to occur in 15 to 20 minutes and death may occur within a few hours. Symptoms of overdose may include:

• Restlessness
• Vision loss or changes
• Memory loss
• Dizziness
• Shaking, tremors, or convulsions
• Inability to walk
• Difficulty speaking
• Loss of consciousness
• Stupor, seizure, or coma
• Heart attack
• Numbness or tingling in the face, tongue, mouth, or throat
• Stiffness or pain in the neck
• Nausea or vomiting
• Irregular breathing

If you experience numbness or tingling in your face, tongue, mouth, or throat, you should not drink or eat until the feelings go away. If the feelings continue or they get worse, get emergency medical attention right away.

Missed Dose of Benzonatate

You should only take benzonatate as scheduled. If you miss a dose of benzonatate, do not take it until the next dose is scheduled, and then only take the normal dosage amount.

You should not take doses between scheduled times, nor take two doses of the medication at the same time.

Potential Adverse Reactions to TESSALON may include:

Hypersensitivity reactions including bronchospasm, laryngospasm, cardiovascular collapse possibly related to local anesthesia from chewing or sucking the capsule.

CNS: sedation; headache; dizziness; mental confusion; visual hallucinations.

GI: constipation; nausea; GI upset.

Dermatologic: pruritus; skin eruptions.

Other: nasal congestion; sensation of burning in the eyes; vague “chilly” sensation; numbness of the chest; hypersensitivity.

Deliberate or accidental overdose has resulted in death, particularly in children.

Tessalon is a prescription medication used to relieve cough. Tessalon belongs to a group of drugs known as cough suppressants, which work by decreasing the cough reflex in the airways and lungs.

Tessalon comes in capsule form and is usually taken by mouth up to 3 times a day. The capsules should be swallowed whole. Do not crush, dissolve, or chew Tessalon capsules.

Common side effects of Tessalon include constipation, headache, and stomach upset. Tessalon can cause drowsiness, dizziness, and visual side effects. Do not drive or operate heavy machinery until you know how Tessalon affects you.
 

• Store benzonatate at controlled room temperature ( 68-77 degrees F).
• Keep benzonatate capsules in a tight, light resistant container.
• Keep this and all medicines out of the reach of children.

Storage

Oral

Tight, light-resistant containers at 15–30°C.100

Tessalon acts peripherally by anesthetizing the stretch receptors located in the respiratory passages, lungs, and pleura by dampening their activity and thereby reducing the cough reflex at its source. It begins to act within 15 to 20 minutes and its effect lasts for 3 to 8 hours. Tessalon has no inhibitory effect on the respiratory center in recommended dosage.

Adults and Children over 10 years of age: Usual dose is one 100 mg capsule three times a day as needed for cough. If necessary to control cough, up to 600 mg daily in three divided doses may be given. Tessalon should be swallowed whole. Tessalon Perles are not to be broken, chewed, dissolved, cut or crushed.

NDC 0069-0122-01

Pfizer

Tessalon®
(benzonatate, USP)
perles

100 mg

100 Perles
Rx only

Applies to benzonatate: oral capsule, oral capsule liquid filled

Along with its needed effects, benzonatate (the active ingredient contained in Tessalon) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking benzonatate:

• Confusion
• difficult breathing
• difficulty with speaking
• seeing things that are not there
• shortness of breath
• tightness in the chest
• wheezing

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

• Change in consciousness
• convulsions (seizures)
• loss of consciousness
• no blood pressure or pulse
• restlessness
• shakiness in the legs, arms, hands, or feet
• stopping of the heart
• trembling or shaking of the hands or feet
• unconsciousness

Some side effects of benzonatate 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:

• Burning sensation in the eyes
• constipation
• dizziness (mild)
• drowsiness (mild)
• headache
• itching
• nausea or vomiting
• skin rash
• stuffy nose