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|DexAlone

DexAlone

DexAlone is used for:

Temporarily relieving cough due to the common cold, upper respiratory tract infections, sinus inflammation, sore throat, or bronchitis.

DexAlone is a cough suppressant. It works by loosening mucus and lung secretions in the chest and making coughs more productive.

Do NOT use DexAlone if:

• you are allergic to any ingredient in DexAlone
• you are taking or have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using DexAlone :

Some medical conditions may interact with DexAlone . Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, plan to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have chronic cough, chronic bronchitis or any breathing problems, such as asthma, emphysema, chronic obstructive pulmonary disease (COPD), or if cough occurs with a large amount of mucus

Some MEDICINES MAY INTERACT with DexAlone . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Furazolidone or MAO inhibitors (eg, phenelzine) because the risk of toxic side effects may be increased by DexAlone

This may not be a complete list of all interactions that may occur. Ask your health care provider if DexAlone may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use DexAlone :

Use DexAlone as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• DexAlone may be taken with or without food. Take with food if stomach upset occurs.
• If you miss a dose of DexAlone and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use DexAlone .

Important safety information:

• This medicine may cause drowsiness, dizziness, blurred vision, or lightheadedness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to DexAlone . Using DexAlone alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
• If your cough lasts for more than 1 week or comes back, or if you also have a fever, rash, or persistent headache, contact your health care provider. A persistent cough could be a sign of a serious condition.
• DexAlone contains dextromethorphan. Before you being taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains dextromethorphan. If it does or if you are not sure, contact your health care provider or pharmacist.
• Phenylketonuria patients - DexAlone contains phenylalanine.
• DexAlone is not recommended for use in CHILDREN younger than 2 years of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you are pregnant or plan on becoming pregnant, discuss with your doctor the benefits and risks of using DexAlone during pregnancy. It is unknown if DexAlone is excreted in breast milk. Do not breast-feed while taking DexAlone .

Possible side effects of DexAlone :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; drowsiness; stomach upset.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include confusion; excitement; hallucinations; slowed breathing.

Store DexAlone between 59 and 86 degrees F (15 and 30 degrees C), away from heat, moisture, and light. Do not store in the bathroom. Keep DexAlone out of the reach of children and away from pets.

General information:

• If you have any questions about DexAlone , please talk with your doctor, pharmacist, or other health care provider.
• DexAlone is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about DexAlone . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.