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|Ulone

CHLOPHEDIANOL (Systemic)*

Some commonly used brand names are:

In Canada—

• Ulone

* Not commercially available in the U.S.

Category

• Antitussive

Description

Chlophedianol (kloe-fe-DYE-a-nole) is used to relieve dry, irritating coughs. This medicine should not be used when there is mucus or phlegm (pronounced flem) with the cough.

Chlophedianol relieves cough by acting on the cough center in the brain.

Chlophedianol is available without a doctor"s prescription; however, your doctor may have special instructions on the proper use of this medicine. It is available in the following dosage form:

• Oral
• Syrup (Canada)

Before Using This Medicine

If you are taking this medicine without a prescription, carefully read and follow any precautions on the label. For chlophedianol, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to chlophedianol. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies on effects in pregnancy have not been done in either humans or animals.

Breast-feeding—It is not known whether chlophedianol passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children—This medicine has been tested in children 2 years of age or older. In effective doses, the medicine has not been shown to cause different side effects or problems in children than it does in adults.

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

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 health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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

• Mucus or phlegm with cough—Since chlophedianol 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

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 chlophedianol 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 chlophedianol. If your dose is different, do not change it unless your doctor tells you to do so.

• 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 are taking this medicine on a regular schedule and you miss a dose, 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—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Keep the syrup from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

If your cough has not improved 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.

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 are normally. 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 .

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

Rare

With large doses

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

Revised: 02/23/1994

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