Description

Promethazine HCl Syrup
(promethazine HCl) Syrup Plain

DESCRIPTION

Each teaspoon (5 mL) of Promethazine HCl Syrup Plain contains 6.25 mg promethazine HCl in a flavored syrup base with a pH between 4.7 and 5.2. Alcohol 7%. The inactive ingredients present are artificial and natural flavors, citric acid, D&C Red 33, D&C Yellow 10, FD&C Blue 1, FD&C Yellow 6, glycerin, saccharin sodium, sodium benzoate, sodium citrate, sodium propionate, water, and other ingredients.

Promethazine HCl is a racemic compound; the empirical formula is C17H20N2S•HCl and its molecular weight is 320.88.

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

 

Promethazine HCl 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.

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Drug Description

Promethazine HCl Syrup
(promethazine HCl) Syrup Plain

DESCRIPTION

Each teaspoon (5 mL) of Promethazine HCl Syrup Plain contains 6.25 mg promethazine HCl in a flavored syrup base with a pH between 4.7 and 5.2. Alcohol 7%. The inactive ingredients present are artificial and natural flavors, citric acid, D&C Red 33, D&C Yellow 10, FD&C Blue 1, FD&C Yellow 6, glycerin, saccharin sodium, sodium benzoate, sodium citrate, sodium propionate, water, and other ingredients.

Promethazine HCl is a racemic compound; the empirical formula is C17H20N2S•HCl and its molecular weight is 320.88.

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

Promethazine HCl 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

INDICATIONS

Promethazine HCl Syrup (promethazine hydrochloride syrup plain) Plain is useful for:

Perennial and seasonal allergic rhinitis.

Vasomotor rhinitis.

Allergic conjunctivitis due to inhalant allergens and foods.

Mild, uncomplicated allergic skin manifestations of urticaria and angioedema.

Amelioration of allergic reactions to blood or plasma.

Dermographism.

Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled.

Preoperative, postoperative, or obstetric sedation.

Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.

Therapy adjunctive to meperidine or other analgesics for control of post-operative pain.

Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused.

Active and prophylactic treatment of motion sickness.

Antiemetic therapy in postoperative patients.

HOW SUPPLIED

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Promethazine HCl Syrup (promethazine hydrochloride syrup plain) Plain is a clear, green solution supplied as follows:

NDC 62559-7481-4 – bottle of 4 fl. oz. (118 mL)
NDC 62559-7481-6 – bottle of 16 fl. oz. (473 mL)

Keep bottles tightly closed.

Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature.]

Protect from light.

Dispense in tight, light-resistant container (USP/NF) with a child-resistant closure.

WARNINGS

Promethazine HCl Syrup (promethazine hydrochloride syrup plain) Plain should not be used in pediatric patients less than 2 years of age because of the potential for fatal respiratory depression.

Promethazine HCl Syrup (promethazine hydrochloride syrup plain) Plain should be used cautiously in persons with cardiovascular disease or with impairment of liver function.

 

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