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Promethazine VC (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 yellowish-orange syrup with odor of apricot peach. 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)   NDC 54868-3935-0.

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

8181658
R5/08-R1



Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma      74146

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