Pronunciation:

ben-ZOE-na-tate

Brand Names:

• Tessalon Perles
• Zonatuss

Dosage Forms:

• Capsule, Liquid Filled
• Capsule

Classifications:

Therapeutic—

Antitussive

Uses of This Medicine:

Benzonatate is used to relieve coughs due to colds or influenza (flu). It is not to be used for chronic cough that occurs with smoking, asthma, or emphysema or when there is an unusually large amount of mucus or phlegm with the cough.

Benzonatate relieves cough by acting directly on the lungs and the breathing passages. It may also act on the cough center in the brain.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of benzonatate in children younger than 10 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies have not been performed on the relationship of age to the effects of benzonatate in the geriatric population. Safety and efficacy have not been established.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Mucus or phlegm with cough—Since benzonatate decreases coughing, it makes it difficult to get rid of the mucus that may collect in the lungs and airways with some diseases.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Swallow the capsules whole. Do not break, crush, or chew them. If the capsules come in contact with the mouth, it may cause the mouth and throat to become numb (loss of feeling) and choking may occur.

If numbness or tingling of the mouth, tongue, throat, or face occurs, do not eat or drink until these symptoms disappear. Check with your doctor right away if these symptoms persist or become worse.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For cough:
    • Adults and children 10 years of age and older—100 milligrams (mg) three times a day. Do not take more than 200 mg at one time or more than 600 mg per day.
    • Children younger than 10 years of age—Use is not recommended.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep the capsules in a child-resistant container and store it out of reach of children at all times.

Throw any unused medicine by mixing it with used coffee grounds or kitty litter and place it in a sealable bag, empty can, or container.

Precautions While Using This Medicine:

It is very important that your doctor check your progress while you or your child are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

If your cough has not become better after 7 days or if you have a high fever, skin rash, or continuing headache with the cough, check with your doctor. These signs may mean that you have other medical problems.

Benzonatate overdose can occur in children (younger than 10 years of age) within 15 to 20 minutes after accidentally taking this medicine. In children under 2 years of age, ingestion of even 1 or 2 capsules has resulted in overdose. Signs and symptoms may include: convulsions (seizures), loss of consciousness, restlessness, or trembling or shakiness in the legs, arms, hands, or feet. If your child took this medicine by accident, call the poison control center (1-800-222-1222) and go to the hospital immediately.

Side Effects of This Medicine:

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.

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

Rare

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:

Symptoms of overdose

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 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:

Less common or rare

Burning sensation in the eyes

constipation

dizziness (mild)

drowsiness (mild)

headache

itching

nausea or vomiting

skin rash

stuffy nose

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.