Creomulsion

• Summit Industries, Inc.

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Do not use dextromethorphan if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Avoid drinking alcohol. It can increase some of the side effects of dextromethorphan.

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with cough medicine can increase your risk of unpleasant side effects.

Ask a doctor or pharmacist before using any cold, allergy, or pain medication. Many medicines available over the counter contain dextromethorphan. Taking certain products together can cause you to get too much of this type of medication. Check the label to see if a medicine contains a cough suppressant.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using dextromethorphan and call your doctor at once if you have:

• severe dizziness, anxiety, restless feeling, or nervousness;

• confusion, hallucinations; or

• slow, shallow breathing.

Common side effects may include stomach upset.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In the U.S.

• Babee Cof Syrup
• Benylin Pediatric Formula
• Children's Pedia Care
• Creomulsion
• Creo-Terpin
• Delsym
• Dexalone
• ElixSure Cough Children's
• Father John's Medicine
• Miltuss
• Nycoff
• Pediacare
• Pediacare Long-Acting Cough
• Robafen Cough
• Robitussin
• Silphen DM
• Simply Cough
• St. Joseph
• Vicks 44 Cough Relief

Available Dosage Forms:

• Suspension, Extended Release
• Solution
• Capsule
• Syrup
• Lozenge/Troche
• Elixir
• Tablet
• Liquid
• Capsule, Liquid Filled
• Suspension

Therapeutic Class: Antitussive

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.

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:

• Blurred vision
• confusion
• difficulty in urination
• drowsiness or dizziness
• nausea or vomiting (severe)
• shakiness and unsteady walk
• slowed breathing
• unusual excitement, nervousness, restlessness, or irritability (severe)

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Confusion
• constipation
• dizziness (mild)
• drowsiness (mild)
• headache
• nausea or vomiting
• stomach pain

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.

Applies to dextromethorphan: oral capsule, oral capsule liquid filled, oral elixir, oral liquid, oral lozenge/troche, oral solution, oral suspension, oral suspension extended release, oral syrup, oral tablet

Along with its needed effects, dextromethorphan (the active ingredient contained in Creomulsion) 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 while taking dextromethorphan:

• Blurred vision
• confusion
• difficulty in urination
• drowsiness or dizziness
• nausea or vomiting (severe)
• shakiness and unsteady walk
• slowed breathing
• unusual excitement, nervousness, restlessness, or irritability (severe)

Some side effects of dextromethorphan may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Confusion
• constipation
• dizziness (mild)
• drowsiness (mild)
• headache
• nausea or vomiting
• stomach pain

Applies to dextromethorphan: compounding powder, oral capsule, oral disintegrating strip, oral drops, oral liquid, oral lozenge, oral solution, oral suspension extended release, oral syrup, oral tablet chewable

General

Adverse effects have included gastrointestinal disturbances such as stomach upset and diarrhea.[Ref]

Nervous system

Frequency not reported: Drowsiness, dizziness, convulsions[Ref]

Respiratory

Frequency not reported: Respiratory depression[Ref]

Gastrointestinal

Frequency not reported: Vomiting, nausea, diarrhea, abdominal pain, gastrointestinal disturbance[Ref]

Hypersensitivity

Rare (less than 0.1%): Fixed-drug eruptions[Ref]

Psychiatric

Cases of abuse have been reported.[Ref]

Frequency not reported: Mental confusion, excitation, insomnia, abuse[Ref]

Dermatologic

Frequency not reported: Rash, angioedema, pruritus, urticaria[Ref]

Some side effects of Creomulsion may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.