PROMETHAZINE SYRUP PLAIN 6.25 mg/5 mL, (Promethazine Hydrochloride Syrup, USP)

/PROMETHAZINE SYRUP PLAIN 6.25 mg/5 mL, (Promethazine Hydrochloride Syrup, USP)
PROMETHAZINE SYRUP PLAIN 6.25 mg/5 mL, (Promethazine Hydrochloride Syrup, USP)2018-09-06T09:12:40+00:00

Prescription Drug Name:

PROMETHAZINE SYRUP PLAIN 6.25 mg/5 mL, (Promethazine Hydrochloride Syrup, USP)

ID:

97fa8e59-d2cc-4f67-9fb8-0e1b3ce6885a

Code:

34391-3

DESCRIPTION


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displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Each 5 mL (teaspoonful) of Promethazine contains 6.25 mg of promethazine HCl. The inactive ingredients present are artificial banana flavor, artificial fruit flavor, artificial strawberry flavor, ascorbic acid, citric acid anhydrous, dehydrated alcohol, D&C Yellow No. 10, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, glycerin, liquid sugar, methylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate dihydrate, and sodium propionate. Promethazine HCl is a racemic compound; the molecular 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.

CLINICAL PHARMACOLOGY


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displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

Promethazine is a phenothiazine derivative which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. Promethazine is an H1 receptor blocking agent. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. Promethazine is well absorbed from the gastrointestinal tract. Clinical effects are apparent within 20 minutes after oral administration and generally last four to six hours, although they may persist as long as 12 hours. Promethazine is metabolized by the liver to a variety of compounds; the sulfoxides of promethazine and N-demethylpromethazine are the predominant metabolites appearing in the urine.

INDICATIONS AND USAGE


id: 1d6425bf-7dac-4899-b3c1-5f3e65ae62ef
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Promethazine 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.

CONTRAINDICATIONS


id: d0a7eed8-01c9-4d49-8ed3-d8dad3fcb1e4
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Promethazine Syrup is contraindicated for use in pediatric patients less than two years of age. Promethazine Syrup is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines. Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma.

OVERDOSAGE


id: 9f6bc45d-3521-4338-898c-9c506ed1540c
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

Signs and symptoms of overdosage with promethazine HCl range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, unconsciousness, and sudden death. Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex). Stimulation may be evident, especially in children and geriatric patients. Convulsions may rarely occur. A paradoxical-type reaction has been reported in children receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares. Atropine-like signs and symptoms-dry mouth, fixed, dilated pupils, flushing, as well as gastrointestinal symptoms-may occur.

DOSAGE AND ADMINISTRATION


id: d1439232-070a-45bf-9665-69a675243d0e
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

Promethazine Syrup is contraindicated for children under 2 years of age (see WARNINGS-Black Box Warning and Use in Pediatric Patients ).

HOW SUPPLIED


id: 5c0f0eb4-083c-4bde-802c-00f5dcf5e087
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Promethazine Syrup Plain 6.25 mg/5 mL is available as follows: 4 fl oz (118 mL)      NDC 54868-1867-0

PRINCIPAL DISPLAY PANEL – 118 mL Bottle Label


id: a224fb39-ffc5-4691-a7ab-d05c20ced16b
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

NDC 54868-1867-0 PROMETHAZINE
SYRUP PLAIN
6.25 mg/5 mL
(Promethazine Hydrochloride
Syrup, USP)
Alcohol 7.0% DO NOT USE IF INNER FOIL SEAL PRINTED “SEALED
FOR YOUR PROTECTION” IS BROKEN OR MISSING.
BULK CONTAINER —
NOT FOR HOUSEHOLD USE
Rx Only NET: 4 fl oz (118 mL)