Chlophedianol (Oral)

Chlophedianol is used to help with dry, irritating coughs. This medicine should not be used if there is mucus or phlegm (pronounced flem) present with the cough.

Chlophedianol works by affecting the cough center in the brain to relieve coughing.

Chlophedianol can be obtained without a doctor's prescription.

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

This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are taking this medicine.

This medicine may also add to the effects of CNS stimulants, such as appetite suppressants and caffeine-containing beverages like tea, coffee, cocoa, and cola drinks. Avoid drinking large amounts of these beverages while taking this medicine. If you have any questions about this, check with your doctor.

This medicine may cause some people to become drowsy or less alert than they usually are. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

In deciding to use a medicine, you need to think about the risks of taking it compared to the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, consider the following:

Allergies

Let your doctor know if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also inform your healthcare 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.

Pediatric

This medicine has been tested in children 2 years of age or older. At effective doses, the medicine has not shown to cause different side effects or problems in children compared to adults.

Geriatric

Many medicines have not been studied specifically in older adults. Therefore, it may not be known whether they work the same way as they do in younger adults or if they cause different side effects or problems in older adults. There is no specific information comparing the use of chlophedianol in the elderly with use in other age groups.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these cases, your doctor may want to adjust the dose, or other precautions may be needed. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or certain types of food because interactions may happen. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may impact the use of this medicine. Make sure to tell your doctor if you have any other medical issues, especially:

• Mucus or phlegm with cough—Since chlophedianol decreases coughing, it makes it difficult to clear mucus that may build up in the lungs and airways with some diseases.

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 as soon as possible if any of the following side effects occur:

Rare

• Hallucinations (seeing, hearing, or feeling things that are not there)
• nightmares
• skin rash or hives
• unusual excitement or irritability

With large doses

• Blurred vision
• drowsiness or dizziness
• dryness of the mouth
• nausea or vomiting

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.

Do not take liquids immediately after taking this medicine. To do so may decrease the soothing effect of the syrup.

Take this medicine only as directed. Do not take more of it and do not take it more often than your doctor ordered or the label directs you to take. To do so may increase the chance of side effects.

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 (syrup): For cough: Adults and children 12 years of age and older—25 milligrams (mg) every six to eight hours as needed. Children— Up to 2 years of age: Use is not recommended. 2 to 6 years of age: 12.5 mg every six to eight hours as needed. 6 to 12 years of age: 12.5 to 25 mg every six to eight hours as needed.

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

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.