Guaifenex® PSE 60 Extended-release Tablets are indicated for the temporary relief of nasal congestion and cough associated with respiratory tract infections and related conditions such as sinusitis, pharyngitis, bronchitis, and asthma, when these conditions are complicated by tenacious mucous and/or mucous plugs and congestion. The product is effective in productive as well as non-productive cough, but is of particular value in dry, non-productive cough which tends to injure the mucous membrane of the air passages.

Adults and pediatric patients over 12 years of age: One or two tablets every 12 hours not to exceed 4 tablets in 24 hours. Pediatric patients 6 to 12 years: 1 tablet every 12 hours not to exceed 2 tablets in 24 hours. Pediatric patients 2 to 6 years: ½ tablet every 12 hours not to exceed 1 tablet in 24 hours.

Guaifenex® PSE 60 Extended-release Tablets are available as bisected, capsule shaped blue tablets, debossed “ETHEX/214”. Bottles of 100 tablets (NDC 58177-214-04).

Store at controlled room temperature, 15°-30°C (59°-86°F).

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

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

Manufactured by : KV Pharmaceutical Co. for ETHEX Corporation, St. Louis, MO 63043-2413. 8/98. FDA revision date: n/a

Last reviewed on RxList: 8/5/2008
This monograph has been modified to include the generic and brand name in many instances.