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 (pronouncedflem) with the cough.

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

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

Oral
• Syrup (Canada)

Before Using This Medicine

If you are taking this medicinewithout 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 orallergic reaction to chlophedianol. Also tell your health care professionalif you are allergic to any other substances, such as foods, preservatives,or dyes.

Pregnancy?Studies on effects in pregnancy have not been donein either humans or animals.

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

Children?This medicine has been tested in children 2 yearsof age or older. In effective doses, the medicine has not been shown to causedifferent side effects or problems in children than it does in adults.

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

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. Tell your health careprofessional if you are taking any other prescription or nonprescription (over-the-counter[OTC]) medicine.

Other medical problems?The presence of other medicalproblems may affect the use of chlophedianol. Make sure you tell your doctorif 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 lungsand airways with some diseases

Proper Use of This Medicine

Do not takeliquids immediately after taking this medicine. To do so may decrease thesoothing effect of the syrup.

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

Dosing?The dose of chlophedianol will be differentfor different patients. Follow your doctor's orders orthe directions on the label. The following information includes onlythe 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 scheduleand you miss a dose, take it as soon as possible. However, if it is almosttime for your next dose, skip the missed dose and go back to your regulardosing 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 surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

If yourcough 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 signsmay 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 whileyou are taking this medicine.

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

This medicine may cause some people to become drowsy or less alert thanthey are normally. Make sure you know how you react tothis medicine before you drive, use machines, or do anything else that couldbe 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 sideeffects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following sideeffects occur:

Rare

With large doses

Other side effects notlisted above may also occur in some patients. If you notice any other effects,check with your doctor.