Exefen (Pseudoephedrine Hydrochloride / Guaifenesin) - Indications and Dosage

INDICATIONS

EXEFEN-IR 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 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 mucus plugs in the respiratory tract.

DOSAGE AND ADMINISTRATION

Adults and Children over 12 years of age: 1 tablet by mouth every 4-6 hours not to exceed 4 tablets in 24 hours. Children 6 to under 12 years: 1/2 tablet by mouth every 4-6 hours not to exceed 2 tablets in 24 hours.

HOW SUPPLIED

EXEFEN-IR Tablets are supplied as white, oval- shaped tablets, debossed "LL 154"; in bottles of 100 Tablets. NDC 68047-154-01

Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF.

Protect from light and moisture. Store at room temperature, USP.

WARNING: KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Rx Only

Report Adverse Reactions to:
Distributed by:

LARKEN
LABORATORIES

276 Nissan Parkway, Suite B
Canton, MS 39046
Or Call Toll Free: 1-888-527-5522

Manufactured by:

Contract Pharmacal Corp.
135 Adams Ave.
Hauppauge, NY 11788 USA

Rev. 12/08