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

 
 



INDICATIONS AND USAGE

Promethazine HCl, phenylephrine HCl and codeine phosphate syrup is indicated for the temporary relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.

DOSAGE AND ADMINISTRATION

The combination of promethazine hydrochloride, phenylephrine 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

Each 5 mL of reddish-orange, strawberry-flavored syrup contains Promethazine hydrochloride 6.25 mg, phenylephrine hydrochloride 5 mg, codeine phosphate 10 mg; and alcohol 7% and is available in 4 fluid ounce (118 mL), 8 fluid ounce (237 mL), and one pint (473 mL) bottles.

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:
Actavis Mid Atlantic LLC
7205 Windsor Blvd.
Baltimore, MD 21244 USA

FORM NO. 1629
Rev. 1/08
VC2972

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