Promethazine and Codeine (Promethazine Hydrochloride / Codeine Phosphate) - Indications and Dosage

INDICATIONS AND USAGE

Promethazine hydrochloride and codeine phosphate syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.

DOSAGE AND ADMINISTRATION

The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 16 years of age, because the combination may cause fatal respiratory depression in this age population.

The average effective dose for adults (16 years of age and over) is: 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 30 mL in 24 hours.

HOW SUPPLIED

Promethazine hydrochloride and Codeine Phosphate Syrup contains promethazine hydrochloride 6.25 mg/5 mL, codeine phosphate 10 mg/5 mL and alcohol 7 percent, and is available in 4 fl oz and 16 fl oz containers.

Store at 20° - 25°C (68° - 77 °F) [See USP Controlled Room Temperature].

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

Manufactured By:

HI-TECH PHARMACAL CO, INC

Amityville, NY 11701

Rev. 804:04 7/07