Zonatuss

This medication is usually taken as needed. If you are taking benzonatate regularly and you miss a dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

• Atley Pharmaceuticals, Inc.

• Vertical Pharmaceuticals, Inc.

Take benzonatate exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The benzonatate dose your doctor recommends will be based on the severity of your cough and your age.

The recommended dose of benzonatate for the treatment of cough is 100 to 200mg 3 times a day for adults and children over 10 years of age.

If you take too much benzonatate, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away. 

This section provides information on the proper use of a number of products that contain benzonatate. It may not be specific to Zonatuss. Please read with care.

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.

• It is used to relieve coughing.

• Tell all of your health care providers that you take this medicine (Zonatuss). This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
• Keep this medicine (Zonatuss) away from children. Children who take this medicine on accident may have very bad side effects, like seizures, passing out, or heart attack. Death has also happened in children younger than 10 years old. If a child takes this medicine (Zonatuss) on accident, get medical help right away.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p-(butylamino) benzoate; with a molecular weight of 603.00 (av).

Each capsule, for oral administration, contains 150 mg of benzonatate.

In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, microcrystalline cellulose, and silicon dioxide. Capsule shell is composed of gelatin, titanium dioxide, FD&C Blue #1 and D&C Red #28. Imprinting ink is composed of black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution.

Hypersensitivity to benzonatate or related compounds.