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Promethazine and Phenylephrine (Promethazine Hydrochloride / Phenylephrine Hydrochloride) - Indications and Dosage

 
 



INDICATIONS AND USAGE

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

DOSAGE AND ADMINISTRATION

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

The recommended doses are given in the following table:

Adults And Children 12 Years And Over

1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonsful (30 mL) in 24 hours.

Children 6 To Under 12 Years Of Age

½ to 1 teaspoonful (2.5 to 5 mL) every 4 to 6 hours, not to exceed 6 teaspoonsful (30 mL) in 24 hours.

Children 2 To Under 6 Years Of Age

¼ to ½ teaspoonful (1.25 to 2.5 mL) every 4 to 6 hours.

HOW SUPPLIED

This preparation is a yellow-orange colored, fruit-flavored syrup. Each 5 mL (one teaspoonful) contains Promethazine hydrochloride 6.25 mg, phenylephrine hydrochloride 5 mg, and alcohol 7 percent, and is available in bottles of 4 fluid ounce (118 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 as defined in the USP.


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

FORM NO. 1628

Rev. 9/06

VC2788

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