DESCRIPTION

Each ZEPHREX LA ® orange oval-shaped, extended release tablet * for oral administration contains:

Pseudoephedrine HCl .............................................  120 mg

Guaifenesin .............................................................. 600 mg

Contains FD&C Yellow No. 6

Decongestant/Expectorant

CLINICAL PHARMACOLOGY

Pseudoephedrine hydrochloride acts on alpha-adrenergic receptors in the mucosa of the respiratory tract producing vasoconstriction. Pseudoephedrine HCl shrinks swollen nasal mucous membranes, reduces tissue hyperemia, edema, nasal congestion and increases nasal airway patency. Guaifenesin enhances the flow of respiratory tract fluid (RTF). The enhanced flow of less viscid secretions lubricates irritated respiratory tract membranes, promotes ciliary action and facilitates the removal of inspissated mucus. As a result, sinus and bronchial drainage is improved and dry non-productive coughs become more productive and less frequent.

INDICATIONS

ZEPHREX LA is 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 relief of eustachian tube congestion; for adjunctive therapy in serous otitis media; for the symptomatic relief of respiratory conditions characterized by dry non-productive cough and in the presence of tenacious mucus and/or mucous plugs in the respiratory tract.

CONTRAINDICATIONS

ZEPHREX LA is contraindicated in patients with a known hypersensitivity to any of its ingredients. Also contraindicated in patients with severe hypertension, severe coronary artery disease and patients on MAO inhibitor therapy. Should not be used in prostatic hypertrophy.

WARNINGS

Considerable caution should be exercised in patients with hypertension, diabetes mellitus, ischemic heart disease, hyperthyroidism and prostatic hypertrophy. Do not exceed the recommended dosage.

PRECAUTIONS

Hypertensive patients should use ZEPHREX LA 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 of methyldopa, mecamylamine, reserpine, and veratrum alkaloids.

Laboratory Test Interactions --Guaifenesin has been reported to interfere with clinical laboratory determinations or urinary 5-hydroxyindoleacetic acid (5-HIAA) and vanillymandelic acid (VMA).

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

Labor and Delivery --The effects of this product on the mother and the fetus are not known.

Nursing Mothers -- ZEPHREX LA is 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 ZEPHREX LA in children below the age of 6 has not been established.

ADVERSE REACTIONS

Adverse reactions include nausea, cardiac palpitations, increased irritability or excitement, headache, dizziness, and tachycardia.

OVERDOSAGE

May cause systemic effects (nervousness, dizziness, or sleeplessness) which are more likely in infants and in elderly. Habituation and toxic psychosis have followed long-term usage. Excessive dosage may also cause nausea and vomiting. 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 ZEPHREX LA may last up to 12 hours, treatment should be continued for at least that length of time.

DOSAGE AND ADMINISTRATION

Adults--1 tablet every 12 hours. Children 6 to 12 years--1/2 tablet every 12 hours.

HOW SUPPLIED

ZEPHREX LA tablets are orange, oval-shaped tablets debossed with Sanofi on one side and a Z bisect LA on the other side.

Bottles of 100 NDC 0024-2627-01

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Store at 25° C (77° F); excursions permitted to 15°-30° C (59°-86° F)

[see USP Controlled Room Temperature]

DISPENSE IN TIGHT, LIGHT RESISTANT CONTAINERS AS DEFINED BY THE USP/NF.

DISPENSE IN CHILD RESISTANT CONTAINERS.

HPG12791-01-0999SS

262701-9691