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|Benylin Adult Formula Cough Syrup

DEXTROMETHORPHAN (Systemic)

Some commonly used brand names are:

In the U.S.—

• Benylin Adult Formula Cough Syrup
• Benylin Pediatric Cough Suppressant
• Cough-X
• Creo-Terpin
• Delsym Cough Formula
• Diabe-TUSS DM Syrup
• Hold DM
• Pertussin CS Children"s Strength
• Pertussin DM Extra Strength
• Robitussin Maximum Strength Cough Suppressant
• Robitussin Pediatric Cough Suppressant
• Sucrets 4 Hour Cough Suppressant
• Trocal
• Vicks 44 Cough Relief

In Canada—

• Balminil DM
• Balminil DM Children
• Benylin DM
• Benylin DM 12 Hour
• Benylin DM for Children
• Benylin DM for Children 12 Hour
• Broncho-Grippol-DM
• Calmylin #1
• Delsym
• Koffex DM
• Novahistex DM
• Novahistine DM
• Robitussin Pediatric
• Triaminic DM Long Lasting for Children

Category

• Antitussive

Description

Dextromethorphan (dex-troe-meth-OR-fan) is used to relieve coughs due to colds or influenza (flu). It should not be used for chronic cough that occurs with smoking, asthma, or emphysema or when there is an unusually large amount of mucus or phlegm (flem) with the cough.

Dextromethorphan relieves cough by acting directly on the cough center in the brain.

This medicine is available without a prescription; however, your doctor may have special instructions on the proper use of this medicine for your medical condition. It is available in the following dosage forms:

• Oral
• Lozenges (U.S.)
• Extended-release oral suspension (U.S. and Canada)
• Syrup (U.S. and Canada)

Before Using This Medicine

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

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to dextromethorphan or its other ingredients such as, alcohol, artificial sweetener, benzocaine, glucose, granulated sugar, menthol, natural honey flavoring, sucralose, sucrose, or sugar. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Dextromethorphan has not been studied in pregnant women. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether dextromethorphan passes into breast milk. However, dextromethorphan has not been reported to cause problems in nursing babies.

Children—Although there is no specific information comparing use of dextromethorphan in children with use in other age groups, this medicine is not expected 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 dextromethorphan in the elderly with use in other age groups.

Other medicines—Although certain medicines should not be used together at all, in other cases 2 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. When you are taking dextromethorphan it is especially important that your health care professional know if you are taking any of the following:

• Amiodarone (e.g., Cordarone) or
• Fluoexetine (e.g., Prozac) or
• Quinidine—Taking dextromethorphan with any of these medicines may result in increased side effects of dextromethorphan

• Central nervous system (CNS) depressants (medicines that cause drowsiness)—The CNS depressant effects of either these medicines or dextromethorphan may be increased

• Monoamine oxidase (MAO) inhibitors (furazolidone [e.g., Furoxone], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate])—Taking dextromethorphan if you are taking MAO inhibitors or have taken them within the past 2 to 3 weeks may cause coma, dizziness, excited or unusual behavior, fever, high blood pressure, nausea, sluggishness, spasms, and tremors

• Smoking tobacco—Since dextromethorphan decreases coughing, it makes it difficult to get rid of the mucus that may collect in the lungs and airways resulting from smoking

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

• Asthma—Since dextromethorphan decreases coughing, it makes it difficult to get rid of the mucus that collects in the lungs and airways during asthma

• Diabetes (sugar diabetes)—Some products contain sugar and may affect control of blood glucose monitoring

• Liver disease—Dextromethorphan may build up in the body and cause unwanted effects

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

• Slowed breathing—Dextromethorphan may slow the rate of breathing even further

Proper Use of This Medicine

Make certain your health care professional knows if you are on a low-sodium, low-sugar, or any other special diet. Most medicines contain more than their active ingredient, and many liquid medicines contain alcohol.

Use this medicine only as directed by your doctor or the directions on the label . Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor or the label says. Although this effect has happened only rarely, dextromethorphan has become habit-forming (causing mental or physical dependence) in some persons who used too much for a long time.

Dosing—The dose of dextromethorphan 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 dextromethorphan. If your dose is different, do not change it unless your doctor tells you to do so.

The number of capsules or tablets or teaspoonfuls of suspension or syrup that you take depends on the strength of the medicine.

• For lozenge dosage form:
  • For cough:
    • Adults and children 12 years of age and older—5 to 15 mg every two to four hours, as needed.
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.
    • Children 2 to 6 years of age—5 mg every four hours, as needed.
    • Children 6 to 12 years of age—5 to 15 mg every two to six hours, as needed.
• For syrup dosage form:
  • For cough:
    • Adults and children 12 years of age and older—30 mg every six to eight hours, as needed.
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.
    • Children 2 to 6 years of age—3.5 mg every four hours or 7.5 mg every six to eight hours, as needed.
    • Children 6 to 12 years of age—7 mg every four hours or 15 mg every six to eight hours, as needed.
• For extended-release oral suspension dosage form :
  • For cough:
    • Adults and children 12 years of age and older—60 mg every twelve hours, as needed.
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.
    • Children 2 to 6 years of age—15 mg every twelve hours, as needed.
    • Children 6 to 12 years of age—30 mg every twelve hours, as needed.

Missed dose—If you must take this medicine regularly 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:

• Store away from heat and direct light.
• Keep out of the reach of children.
• Do not store the tablet form of this medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the liquid form of this medicine 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, if sore throat has not improved after 2 days, if you have a high fever, skin rash, or continuing headache with the cough, or if asthma or high blood pressure is present, check with your doctor. These signs may mean that you have other medical problems.

Dissolve lozenges in the mouth with caution, to lessen the risk of choking.

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:

Other 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. However, check with your health care professional if any of the following side effects continue or are bothersome:

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

Revised: 06/11/1999

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