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|Hexafed Controlled-Release Tablets

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Hexafed Controlled-Release Tablets

Generic Name: Dexchlorpheniramine/Pseudoephedrine Controlled-Release Tablets (dex-klor-fen-IR-a-meen/soo-doe-e-FED-rin)
Brand Name: Hexafed

Hexafed Controlled-Release Tablets is used for:

Relieving congestion, sneezing, runny nose, nasal or throat itching, and itchy or watery eyes caused by colds, hay fever, or other allergic conditions. It may also be used for other conditions as determined by your doctor.

Hexafed Controlled-Release Tablets is an antihistamine and decongestant combination. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant promotes sinus and nasal drainage, relieving congestion and pressure.

Do NOT use Hexafed Controlled-Release Tablets if:

you are allergic to any ingredient in Hexafed Controlled-Release Tablets
you are also taking droxidopa or sodium oxybate (GHB), or you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days
you have severe high blood pressure or severe coronary artery disease or ischemic heart disease

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

Before using Hexafed Controlled-Release Tablets:

Some medical conditions may interact with Hexafed Controlled-Release Tablets. 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 asthma, breathing problems (eg, emphysema, chronic bronchitis), heart or blood vessel disease, ulcer, blockage of the stomach or intestines, difficulty urinating, blockage of the bladder, an overactive thyroid (hyperthyroidism), diabetes, seizures, glaucoma, increased pressure in the eye, or high blood pressure
if you have an enlarged prostate or prostate disease
if you have trouble sleeping

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

Furazolidone or MAO inhibitors (eg, phenelzine) because side effects, such as severe headaches, high fever, and high blood pressure, may occur
Droxidopa because side effects, such as irregular heartbeat or heart attack, may occur
Urinary alkalinizers (eg, sodium bicarbonate) because the side effects of Hexafed Controlled-Release Tablets may be increased
Sodium oxybate because side effects, such as severe drowsiness, may occur
Bromocriptine because the risk of side effects and toxic effects may be increased by Hexafed Controlled-Release Tablets
Guanethidine, guanadrel, mecamylamine, methyldopa, or reserpine because effectiveness may be decreased by Hexafed Controlled-Release Tablets

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

Use Hexafed Controlled-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Hexafed Controlled-Release Tablets may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
Swallow Hexafed Controlled-Release Tablets whole. Do not crush or chew before swallowing. Hexafed Controlled-Release Tablets may be broken in half and swallowed without crushing or chewing.
If you miss a dose of Hexafed Controlled-Release Tablets and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Hexafed Controlled-Release Tablets.

Important safety information:

Hexafed Controlled-Release Tablets may cause drowsiness, dizziness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Hexafed Controlled-Release Tablets. Using Hexafed Controlled-Release Tablets alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Hexafed Controlled-Release Tablets. Hexafed Controlled-Release Tablets will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
If you have trouble sleeping, ask your doctor or pharmacist about the best time of day to take Hexafed Controlled-Release Tablets.
If you are scheduled for allergy skin testing, do not take Hexafed Controlled-Release Tablets for several days before the test because it may decrease your response to the skin tests.
Hexafed Controlled-Release Tablets contains pseudoephedrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains pseudoephedrine. If it does or if you are uncertain if it does, contact your doctor or pharmacist.
Do not exceed the recommended dose or take Hexafed Controlled-Release Tablets for longer than prescribed without checking with your doctor.
Do not take diet or appetite control medicines while you are taking Hexafed Controlled-Release Tablets without checking with your doctor.
Use Hexafed Controlled-Release Tablets with caution in the ELDERLY because they may be more sensitive to its effects.
Hexafed Controlled-Release Tablets is not recommended for use in CHILDREN younger than 6 years of age. Safety and effectiveness in this age group have not been confirmed.
Caution is advised when using Hexafed Controlled-Release Tablets in CHILDREN because they may be more sensitive to its effects, especially excitability.
PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Hexafed Controlled-Release Tablets during pregnancy. Hexafed Controlled-Release Tablets is excreted in breast milk. Do not breast-feed while taking Hexafed Controlled-Release Tablets.

Possible side effects of Hexafed Controlled-Release Tablets:

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:

Constipation; diarrhea; dizziness; drowsiness; dry mouth, throat, or nose; excitability; headache; loss of appetite; nausea; nervousness; restlessness; trouble sleeping; vomiting.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; chest pain; decreased coordination; difficulty urinating; fast or irregular heartbeat; fever; hallucinations; ringing in the ears; seizures; severe dizziness or drowsiness; severe nervousness, anxiety, or restlessness; tremors; unusual weakness.

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 bluish-colored skin; difficulty breathing; dilated pupils; fast or irregular heartbeat; fever; flushing; hallucinations; mental or mood changes; seizures; severe drowsiness or dizziness; severe excitability; severe nausea or vomiting; sweating; tremors; trouble breathing.

Proper storage of Hexafed Controlled-Release Tablets:

Store Hexafed Controlled-Release Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Hexafed Controlled-Release Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Hexafed Controlled-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
Hexafed Controlled-Release Tablets 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 Hexafed Controlled-Release Tablets. 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.

Issue Date: November 1, 2006

Database Edition 06.4.1.002

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