PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Promethazine Hydrochloride Oral Solution, USP 6.25 mg/5 mL - NDC 62135-774-41 - 120 mL Bottle Label


Promethazine Hydrochloride Oral Solution, USP 6.25 mg/5 mL - NDC 62135-774-47 - 473 mL Bottle Label


Promethazine Hydrochloride Oral Solution, USP 6.25 mg/5 mL - NDC 62135-774-05 - 5 mL Cup Label


Promethazine Hydrochloride Oral Solution, USP 12.5 mg/10 mL - NDC 62135-774-10 - 10 mL Cup Label


DESCRIPTION

Each 5 mL (teaspoonful) of Promethazine Hydrochloride Oral Solution, USP contains: 6.25 mg of Promethazine Hydrochloride, USP.

The inactive ingredients present are alcohol 7%, ascorbic acid, citric acid anhydrous, D&C Yellow No. 10, FD&C Red No. 40, FD&C Blue No. 1, FD&C Yellow No. 6, methylparaben, natural cherry flavor, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate dihydrate, and sucrose. Citric acid anhydrous or sodium citrate dihydrate is used to adjust the pH to 4.6 to 5.0.

Promethazine Hydrochloride, USP is a racemic compound; the empirical formula is C 17H 20N 2S•HCl and its molecular weight is 320.88.

Promethazine Hydrochloride, USP, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine,N,N,á-trimethyl-, monohydrochloride,(±)-, with the following structural formula:


Promethazine Hydrochloride, USP occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol.

HOW SUPPLIED

Promethazine Hydrochloride Oral Solution, USP 6.25 mg/ 5mL is a green colored viscous syrup with a light cherry odor is supplied as follows:

bottle of 120 mL – NDC 62135-774-41

bottle of 473 mL – NDC 62135-774-47

Unit Dose Cup of 5 mL – NDC 62135-774-05

20 Unit Dose Cups of 5 mL – NDC 62135-774-24

Unit Dose Cup of 10 mL – NDC 62135-774-10

20 Unit Dose Cups of 10 mL – NDC 62135-774-23

Keep tightly closed.

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

Protect from light.

Dispense in light-resistant, tight container.

Manufactured for:

Chartwell RX, LLC.

Congers, NY 10920

Rev: 02/2025

L71724

DOSAGE AND ADMINISTRATION

Promethazine Hydrochloride Oral Solution is contraindicated for children under 2 years of age(see WARNINGS - Black Box Warningand Use in Pediatric Patients).

Allergy

The average oral dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. Children tolerate this product well. Single 25 mg doses at bedtime or 6.25 to 12.5 mg taken three times daily will usually suffice. After initiation of treatment in children or adults, dosage should be adjusted to the smallest amount adequate to relieve symptoms.

The administration of promethazine HCl in 25 mg doses will control minor transfusion reactions of an allergic nature.

Motion Sickness

The average adult dose is 25 mg taken twice daily. The initial dose should be taken one-half to one hour before anticipated travel and be repeated 8 to 12 hours later, if necessary. On succeeding days of travel, it is recommended that 25 mg be given on arising and again before the evening meal. For children, promethazine hydrochloride tablets, oral solution or rectal suppositories 12.5 to 25 mg, twice daily, may be administered.

Nausea and Vomiting

Antiemetics should not be used in vomiting of unknown etiology in children and adolescents (see WARNINGS- Use in Pediatric Patients).

The average effective dose of promethazine hydrochloride for the active therapy of nausea and vomiting in children or adults is 25 mg. When oral medication cannot be tolerated, the dose should be given parenterally (cf. Promethazine Hydrochloride Injection) or by rectal suppository. 12.5 to 25 mg doses may be repeated, as necessary, at 4 to 6 hour intervals.

For nausea and vomiting in children, the usual dose is 0.5 mg per pound of body weight, and the dose should be adjusted to the age and weight of the patient and the severity of the condition being treated.

For prophylaxis of nausea and vomiting, as during surgery and the post- operative period, the average dose is 25 mg repeated at 4 to 6 hour intervals, as necessary.

Sedation

This product relieves apprehension and induces a quiet sleep from which the patient can be easily aroused. Administration of 12.5 to 25 mg promethazine hydrochloride by the oral route or by rectal suppository at bedtime will provide sedation in children. Adults usually require 25 to 50 mg for nighttime, presurgical, or obstetrical sedation.

Pre-and Postoperative Use

Promethazine hydrochloride in 12.5 to 25 mg doses for children and 50 mg doses for adults the night before surgery relieves apprehension and produces a quiet sleep.

For preoperative medication children require doses of 0.5 mg per pound of body weight in combination with an appropriately reduced dose of narcotic or barbiturate and the appropriate dose of an atropine-like drug.

Usual adult dosage is 50 mg promethazine hydrochloride with an appropriately reduced dose of narcotic or barbiturate and the required amount of a belladonna alkaloid.

Postoperative sedation and adjunctive use with analgesics may be obtained by the administration of 12.5 to 25 mg in children and 25 to 50 mg doses in adults.

Promethazine Hydrochloride Oral Solution is contraindicated for children under 2 years of age.