Promethazine DM (Dextromethorphan Hydrobromide / Promethazine Hydrochloride) - Indications and Dosage

INDICATIONS AND USAGE

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

DOSAGE AND ADMINISTRATION

Promethazine hydrochloride and dextromethorphan hydrobromide syrup is contraindicated for children under 2 years of age (see WARNINGS – Black Box Warning and Use In Pediatric Patients ).

The average effective dose is given in the following table:

Adults	1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 30 mL in 24 hours.
Children 6 Years To Under 12 Years	½ to 1 teaspoonful (2.5 to 5 mL) every 4 to 6 hours, not to exceed 20 mL in 24 hours.
Children 2 Years To Under 6 Years	¼ to ½ teaspoonful (1.25 to 2.5 mL) every 4 to 6 hours, not to exceed 10 mL in 24 hours.

HOW SUPPLIED

This preparation is a clear syrup with yellow color and pineapple menthol odor, containing promethazine hydrochloride 6.25 mg/5 mL, dextromethorphan hydrobromide 15 mg/5 mL and alcohol 7 percent, and is available in 4 fluid ounce (118 mL), 8 fluid ounce (237 mL) and one pint (473 mL).

Keep tightly closed. Protect from light.

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

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

Manufactured for:
QUALITEST PHARMACEUTICALS
Huntsville, AL 35811

8181650
R12/07-R1