DrugindexOnline^{2nd edition}

Generic Name: Guaifenesin/Pseudoephedrine Controlled-Release Capsules and Sustained-Release Capsules (gwye-FEN-ah-sin/sue-do-eh-FED-rin)
Brand Name: Examples include Entex PSE and Nalex CR

Nalex CR Controlled-Release Capsules is used for:

Relieving congestion, cough, and throat and airway irritation due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Nalex CR Controlled-Release Capsules is a decongestant and expectorant combination. It works by constricting blood vessels, reducing swelling in the nasal passages, and thinning and loosening mucus in the airway. This allows you to breathe more easily and makes coughs more productive.

Do NOT use Nalex CR Controlled-Release Capsules if:

• you are allergic to any ingredient in Nalex CR Controlled-Release Capsules
• you have severe high blood pressure, rapid heartbeat, or other severe heart problems (eg, heart blood vessel disease)
• you 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 Nalex CR Controlled-Release Capsules:

Some medical conditions may interact with Nalex CR Controlled-Release Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning 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 a fast, slow, or irregular heartbeat
• if you have a history of adrenal gland problems (eg, tumor), heart problems, high blood pressure, diabetes, heart blood vessel problems, stroke, glaucoma, an enlarged prostate, seizures, or an overactive thyroid
• if you have chronic cough

Some MEDICINES MAY INTERACT with Nalex CR Controlled-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), COMT inhibitors (eg, tolcapone), furazolidone, indomethacin, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Nalex CR Controlled-Release Capsules's side effects
• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased
• Bromocriptine because the risk of its side effects may be increased by Nalex CR Controlled-Release Capsules
• Guanethidine, guanadrel, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Nalex CR Controlled-Release Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Nalex CR Controlled-Release Capsules 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 Nalex CR Controlled-Release Capsules:

Use Nalex CR Controlled-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Nalex CR Controlled-Release Capsules by mouth with or without food.
• Take Nalex CR Controlled-Release Capsules with a full glass of water (8 oz/240 mL) unless your doctor tells you otherwise.
• If you miss a dose of Nalex CR Controlled-Release Capsules, 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 Nalex CR Controlled-Release Capsules.

Important safety information:

• Nalex CR Controlled-Release Capsules may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Nalex CR Controlled-Release Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not take appetite suppressants while you are taking Nalex CR Controlled-Release Capsules without checking with your doctor.
• Nalex CR Controlled-Release Capsules has pseudoephedrine in it. Before you start any new medicine, check the label to see if it has pseudoephedrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor.
• Nalex CR Controlled-Release Capsules may interfere with certain lab test results. Make sure that all of your doctors and lab personnel know that you are taking Nalex CR Controlled-Release Capsules.
• Tell your doctor or dentist that you take Nalex CR Controlled-Release Capsules before you receive any medical or dental care, emergency care, or surgery.
• Use Nalex CR Controlled-Release Capsules with caution in the ELDERLY; they may be more sensitive to its effects.
• Caution is advised when using Nalex CR Controlled-Release Capsules in CHILDREN; they may be more sensitive to its effects.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Nalex CR Controlled-Release Capsules, contact your doctor. You will need to discuss the benefits and risks of using Nalex CR Controlled-Release Capsules while pregnant. It is not known if Nalex CR Controlled-Release Capsules is found in breast milk. Do not breast-feed while taking Nalex CR Controlled-Release Capsules.

Possible side effects of Nalex CR Controlled-Release Capsules:

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; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor.

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 blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Nalex CR Controlled-Release Capsules:

Store Nalex CR Controlled-Release Capsules at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Nalex CR Controlled-Release Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about Nalex CR Controlled-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.
• Nalex CR Controlled-Release Capsules 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 Nalex CR Controlled-Release Capsules. 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.