Each Entex PSE yellow coated, scored, long-acting tablet for oral administration contains

pseudoephedrine hydrochloride     120 mg

guaifenesin      600 mg

in a special base to provide a prolonged therapeutic effect.

This product contains ingredients of the following therapeutic classes: decongestant and expectorant.

Pseudoephedrine hydrochloride is a decongestant having the chemical name, benzenemethanol,(alpha)-[1-(methylamino)ethyl]-[ S -( R*, R* ) ]-, hydrochloride.

Guaifenesin is an expectorant having the chemical name, 1,2-propanediol, 3-(2-methoxyphenoxy)-.

Inactive Ingredients: Each tablet contains compressible sugar, D&C Yellow No. 10 Aluminum Lake, dioctyl sodium sulfosuccinate, FD&C Yellow No. 6 Aluminum Lake, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol, purified water, silicon dioxide, sodium citrate, stearic acid, and titanium dioxide.

Entex PSE tablets are indicated for the relief of nasal congestion due to the common cold, hay fever or other upper respiratory allergies, and nasal congestion associated with sinusitis. To promote nasal or sinus drainage; for the symptomatic relief of respiratory conditions characterized by dry nonproductive cough and in the presence of tenacious mucus and/or mucous plugs in the respiratory tract.

Adults and adolescents 12 years of age and older:   one tablet twice daily (every 12 hours).

Children 6 to under 12 years:   one-half ( ¹ / ₂ ) tablet twice daily (every 12 hours). Entex PSE tablets are not recommended for pediatric patients under 6 years of age.

Tablets may be broken in half for ease of administration without affecting release of medication but should not be crushed or chewed prior to swallowing.

Entex PSE tablets are coated yellow, scored and coded with "Entex PSE" on one side and "032 032" on the scored side.

NDC 51479-032-01 bottles of 100

Store at controlled room temperature (59°-77°F or 15°-25°C).

Dispense in tight, light-resistant containers as defined in USP.

Rx only.  

Manufactured by
WelPharm, Inc.
Irvine, CA 92614

Manufactured for
DURA Pharmaceuticals, Inc.
San Diego, CA 92121

Gastrointestinal:   nausea and vomiting.

Central Nervous System:   nervousness, dizziness, sleeplessness, lightheadedness, tremor, hallucinations, convulsions, CNS depression, fear, anxiety, headache, increased irritability or excitement.

Cardiovascular:   palpitations, tachycardia, cardiovascular collapse and death.

General:   weakness.

Respiratory:   respiratory difficulties.

MAO inhibitors and beta adrenergic blockers increase effects of sympathomimetics. Sympathomimetics may reduce the antihypertensive effects if methyldopa, guanethidine, mecamylamine, reserpine and veratrum alkaloids.

Sympathomimetic amines should be used with caution in patients with hypertension, diabetes mellitus, heart disease, peripheral vascular disease, increased intraocular pressure, hyperthyroidism, or prostatic hypertrophy.

General:   Hypertensive patients should use Entex PSE tablets only with medical advice, as they may experience a change in blood pressure due to added vasoconstriction.

Information for Patients:   Persistent cough may indicate a serious condition. If cough persists for more than one week, tends to recur, or is accompanied by a high fever, rash, or persistent headache, consult a physician.

Drug Interactions:   MAO inhibitors and beta adrenergic blockers increase effects of sympathomimetics. Sympathomimetics may reduce the antihypertensive effects if methyldopa, guanethidine, mecamylamine, reserpine and veratrum alkaloids.

Drug/Laboratory Test Interactions:   Guaifenesin has been reported to interfere with clinical laboratory determinations of urinary 5-hydroxyindoleacetic acid (5-HIAA) and urinary vanillylmandelic acid (VMA).

Pregnancy:   Pregnancy Category C. Animal reproduction studies have not been conducted with Entex PSE tablets. It is also not known whether Entex PSE tablets can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Entex PSE tablets should be given to a pregnant woman only if clearly needed.

Nursing Mothers:   Entex PSE tablets are contraindicated in the nursing mother because of the higher than usual risks to infants from sympathomimetic agents.

Usage in Elderly:   Patients 60 years and older are more likely to experience adverse reactions to sympathomimetics. Overdose may cause hallucinations, convulsions, CNS depression and death. Demonstrate safe use of a short-acting sympathomimetic before use of a sustained action formulation in elderly patients.

Pediatric Use:   Safety and effectiveness of Entex PSE tablets in pediatric patients below the age of 6 have not been established.

Symptoms:   Overdose may cause hallucinations, convulsions, CNS depression, cardiovascular collapse and death.

Treatment:   Treatment of overdosage should provide symptomatic care. If the amount ingested is considered dangerous or excessive, induce vomiting with ipecac syrup unless the patient is convulsing, comatose, or has lost the gag reflex, in which case, perform gastric lavage using a large-bore tube. If indicated, follow with activated charcoal and a saline cathartic. Since the effects of Entex PSE tablets may last up to 12 hours, treatment should be continued for at least that length of time.

Entex PSE tablets are contraindicated in patients with a known hypersensitivity to any of its ingredients, in nursing mothers, or in patients with severe hypertension, severe coronary artery disease, prostatic hypertrophy, or in patients on MAO inhibitor therapy.

Pseudoephedrine hydrochloride is an (alpha)-adrenergic receptor agonist (sympathomimetic) which produces vasoconstriction by stimulating (alpha)-receptors within the mucosa of the respiratory tract. Clinically, pseudoephedrine shrinks swollen mucous membranes, reduces tissue hyperemia, edema, and nasal congestion, and increases nasal airway patency. Guaifenesin promotes lower respiratory tract drainage by thinning bronchial secretions, lubricates irritated respiratory tract membranes through increased mucous flow, and facilitates removal of viscous, inspissated mucus. As a result of these drugs, sinus and bronchial drainage is improved, and dry, nonproductive coughs become more productive and less frequent.

Persistent cough may indicate a serious condition. If cough persists for more than one week, tends to recur, or is accompanied by a high fever, rash, or persistent headache, consult a physician.

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

GUAIFENESIN/PSEUDOEPHEDRINE SUSTAINED-RELEASE - ORAL

(gweye-FEN-eh-sin/sue-doh-eff-ED-rin)

USES: Guaifenesin/pseudoephedrine is used for the temporary relief of nose/sinus/ear congestion and cough with phlegm caused by the common cold, allergies, or infection. Pseudoephedrine is called a sympathomimetic and works by decreasing the swelling of nose and ear tissues and opening nose passages. Guaifenesin is called an expectorant. It works by making phlegm in the breathing tubes more liquid. This helps the cough to clear phlegm better.

Do not use this medication in children younger than 6 years unless specifically directed by the doctor. Some products are not recommended for use in children younger than 12 years. Consult with the doctor or pharmacist regarding your specific product. To decrease the risk for serious side effects, carefully follow all of the doctor's dosage directions. Do not give other cough and cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask your doctor or pharmacist about other ways to relieve cough and cold symptoms (e.g., saline nose drops/spray, using a humidifier or infant nasal suction bulb).

HOW TO USE: Take this medication by mouth, usually every 12 hours with a full glass of water or as directed by your doctor. If stomach upset occurs, take with food or milk. Sustained-release products should be swallowed whole. Do not crush, chew, or split this medication. Doing so can destroy the long action of the drug and may increase side effects.

Dosage is based on your age, medical condition and response to therapy. If this medication does not require a prescription from your doctor, follow the specific dosing instructions on the packaging to find the correct dose for your age.

If your doctor directs you to take this medication daily, take it regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.

If your symptoms do not improve after 7 days, if they worsen, or if you develop a fever/chills, contact your doctor. Do not take more medication than is recommended.

SIDE EFFECTS: Mild stomach upset, trouble sleeping, dizziness, lightheadedness, headache, nervousness, fast heartbeat, loss of appetite, shaking, or unusual sweating may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

This product may reduce blood flow to your hands and feet, causing them to feel cold. Smoking may worsen this effect. Dress warmly and avoid tobacco use.

If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fast/irregular heartbeat, severe/uncontrolled shaking, difficulty urinating, decreased sexual ability.

Tell your doctor immediately if any of these rare but very serious side effects occur: seizures, mental/mood changes (e.g., anxiety, panic, hallucinations).

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, tell your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to pseudoephedrine or guaifenesin; or if you have any other allergies. Also tell your doctor if you have had a negative reaction to other sympathomimetics (e.g., ephedrine, phenylephrine).

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe high blood pressure, heart disease (e.g., severe coronary artery disease, angina, heart failure), certain types of fast heart rhythm problems (e.g., atrial fibrillation/flutter, paroxysmal supraventricular tachycardia-PSVT), a certain slow heart rhythm problem (sinus bradycardia), closed-angle glaucoma, difficulty urinating (e.g., due to enlarged prostate).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: stroke, high blood pressure, chest pain (angina), heart attack, smoking, long-term breathing problems (e.g., asthma, chronic bronchitis, emphysema), cough with large amounts of phlegm, mental/mood disorders (e.g., anxiety, bipolar disorder, mania), epilepsy/seizure problems, certain blood vessel problems (e.g., Raynaud's disease, peripheral vascular disease), overactive thyroid (hyperthyroidism), low blood flow to the brain (cerebral insufficiency), diabetes, difficulty sleeping.

This drug may make you dizzy or lightheaded; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages.

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially dizziness and lightheadedness.

Caution is advised when using this product in children because they may be more sensitive to its side effects, especially excitation, agitation, and increased blood pressure.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

The pseudoephedrine in this product passes into breast milk. It is not known whether guaifenesin passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medications because very serious interactions may occur: MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine).

Avoid taking MAO inhibitors within 2 weeks before, during, and after treatment with this medication. In some cases a serious, possibly fatal drug interaction may occur.

If you are currently using any of these medications, tell your doctor or pharmacist before starting this product.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other decongestants (taken by mouth or sprayed into the nose), products containing caffeine, some blood pressure medications (e.g., beta blockers, calcium channel blockers, reserpine, guanethidine, methyldopa, mecamylamine), tricyclic antidepressants (e.g., nortriptyline, amitriptyline), digoxin.

Pseudoephedrine may worsen the serious side effects of some medications used for migraine headaches (e.g., sumatriptan, naratriptan, zolmitriptan, ergotamine). Consult your pharmacist or doctor for more details.

Check the labels on all your medicines (e.g., cough-and-cold products, diet aids) because they may contain ingredients that could increase your heart rate or blood pressure. Ask your pharmacist about the safe use of those products before using them.

Pseudoephedrine and guaifenesin are available in both prescription and nonprescription products. Check the labels of all your medications carefully to make sure you are not taking more than one product containing these medications.

The guaifenesin in this product can affect the results of certain lab tests (e.g., uric acid levels, 5-hydroxyindoleacetic acid levels, vanillylmandelic acid levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe dizziness/fainting, severe weakness, fast irregular heartbeat, slow/shallow breathing, hallucinations, seizures, vomiting.

NOTES: Do not share this medication with others.

Drink plenty of fluids while taking this medication unless your doctor instructs you otherwise. This may help to relieve congestion. This medication is for temporary use only. Do not use for more than 7 days without first consulting your doctor.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature at 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.