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.
Promethazine hydrochloride and codeine phosphate syrup (clear purple color, grape flavor) contains promethazine hydrochloride 6.25 mg/5 mL, codeine phosphate 10 mg/5 mL and alcohol 7%, and is available in the following oral dosage form: NDC 0121-0547-05 (unit dose cups of 5 mL, 10 × 10's).
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.
Pharmaceutical Associates, Inc.
Greenville, SC 29605