displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Each 5 mL (one teaspoonful), for oral administration contains: Dextromethorphan hydrobromide 15 mg; promethazine hydrochloride 6.25 mg. Alcohol 7%.
Inactive Ingredients: Ascorbic acid, citric acid, D&C yellow #10, FD&C yellow #6, menthol, methylparaben, orange pineapple flavor, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate and sucrose.
Dextromethorphan hydrobromide is a salt of the methyl ether of the dextrorotatory isomer of levorphanol, a narcotic analgesic. It is chemically designated as 3-methoxy-17-methyl-9α, 13α, 14α-morphinan hydrobromide monohydrate. Dextromethorphan hydrobromide occurs as white crystals sparingly soluble in water and freely soluble in alcohol. It has a molecular weight of 370.32, a molecular formula of C18H25NO•HBr•H2O, and the following structural formula:
Promethazine is a racemic compound. Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as 10H-Phenothiazine-10-ethanamine, N,N, α-trimethyl-monohydrochloride.
Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of C17H20N2S•HCI, and the following structural formula:
INDICATIONS AND USAGE
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Promethazine hydrochloride and dextromethorphan hydrobromide syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Dextromethorphan should not be used in patients receiving a monoamine oxidase inhibitor (MAOI) (see
Promethazine 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.
Use In Pediatric Patients
displayName: PEDIATRIC USE SECTION
FDA Article Code: 34081-0
PROMETHAZINE PRODUCTS ARE CONTRAINDICATED FOR USE IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF AGE.
CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE PRODUCTS TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. RESPIRATORY DEPRESSION AND APNEA, SOMETIMES ASSOCIATED WITH DEATH, ARE STRONGLY ASSOCIATED WITH PROMETHAZINE PRODUCTS AND ARE NOT DIRECTLY RELATED TO INDIVIDUALIZED WEIGHT-BASED DOSING, WHICH MIGHT OTHERWISE PERMIT SAFE ADMINISTRATION. CONCOMITANT ADMINISTRATION OF PROMETHAZINE PRODUCTS WITH OTHER RESPIRATORY DEPRESSANTS HAS AN ASSOCIATION WITH RESPIRATORY DEPRESSION, AND SOMETIMES DEATH, IN PEDIATRIC PATIENTS.
ANTIEMETICS ARE NOT RECOMMENDED FOR TREATMENT OF UNCOMPLICATED VOMITING IN PEDIATRIC PATIENTS, AND THEIR USE SHOULD BE LIMITED TO PROLONGED VOMITING OF KNOWN ETIOLOGY. THE EXTRAPYRAMIDAL SYMPTOMS WHICH CAN OCCUR SECONDARY TO PROMETHAZINE HYDROCHLORIDE ADMINISTRATION MAY BE CONFUSED WITH THE CNS SIGNS OF UNDIAGNOSED PRIMARY DISEASE, e.g., ENCEPHALOPATHY OR REYE’S SYNDROME. THE USE OF PROMETHAZINE PRODUCTS SHOULD BE AVOIDED IN PEDIATRIC PATIENTS WHOSE SIGNS AND SYMPTOMS MAY SUGGEST REYE’S SYNDROME OR OTHER HEPATIC DISEASES.
Excessively large dosages of antihistamines, including promethazine hydrochloride, in pediatric patients may cause sudden death (see
). Hallucinations and convulsions have occurred with therapeutic doses and overdoses of promethazine hydrochloride in pediatric patients. In pediatric patients who are acutely ill associated with dehydration, there is an increased susceptibility to dystonias with the use of promethazine HCl.
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5
Administration of promethazine has been associated with reported cholestatic jaundice.
displayName: PRECAUTIONS SECTION
FDA Article Code: 42232-9
Animal reproduction studies have not been conducted with the drug combination–promethazine and dextromethorphan. It is not known whether this drug combination can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Promethazine and dextromethorphan should be given to a pregnant woman only if clearly needed.
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
Dextromethorphan hydrobromide occasionally causes slight drowsiness, dizziness, and gastrointestinal disturbances.
Central Nervous System – Drowsiness is the most prominent CNS effect of this drug. Sedation, somnolence, blurred vision, dizziness; confusion, disorientation, and extrapyramidal symptoms such as oculogyric crisis, torticollis, and tongue protrusion; lassitude, tinnitus, incoordination, fatigue, euphoria, nervousness, diplopia, insomnia, tremors, convulsive seizures, excitation, catatonic-like states, hysteria. Hallucinations have also been reported.
Cardiovascular – Increased or decreased blood pressure, tachycardia, bradycardia, faintness.
Dermatologic – Dermatitis, photosensitivity, urticaria.
Hematologic – Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis.
Gastrointestinal – Dry mouth, nausea, vomiting, jaundice.
Respiratory – Asthma, nasal stuffiness, respiratory depression (potentially fatal) and apnea (potentially fatal). (See
Other – Angioneurotic edema. Neuroleptic malignant syndrome (potentially fatal) has also been reported. (See
Neuroleptic Malignant Syndrome.)
Paradoxical Reactions – Hyperexcitability and abnormal movements have been reported in patients following a single administration of promethazine HCl. Consideration should be given to the discontinuation of promethazine HCl and to the use of other drugs if these reactions occur. Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients.
DRUG ABUSE AND DEPENDENCE
displayName: DRUG ABUSE AND DEPENDENCE SECTION
FDA Article Code: 42227-9
According to the WHO Expert Committee on Drug Dependence, dextromethorphan could produce very slight psychic dependence but no physical dependence.
DOSAGE AND ADMINISTRATION
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Promethazine hydrochloride and dextromethorphan hydrobromide syrup is contraindicated for children under 2 years of age (see
Black Box Warning
Use In Pediatric Patients
The average effective dose is given in the following table:
1 teaspoonful (5 mL) every 4 to 6 hours,
not to exceed 30 mL in 24 hours.
Children 6 Years To Under 12 Years
½ to 1 teaspoonful (2.5 to 5 mL) every 4 to 6 hours,
not to exceed 20 mL in 24 hours.
Children 2 Years To Under 6 Years
¼ to ½ teaspoonful (1.25 to 2.5 mL) every 4 to 6 hours,
not to exceed 10 mL in 24 hours.
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
This preparation is a clear syrup with yellow color and pineapple menthol odor, containing promethazine hydrochloride 6.25 mg/5 mL, dextromethorphan hydrobromide 15 mg/5 mL and alcohol 7 percent, and is available in 4 fluid ounce (118 mL) NDC 54868-1990-0 and one pint (473 mL) NDC 54868-1990-1.
PRINCIPAL DISPLAY PANEL
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
PROMETHAZINE DM (dextromethorphan hydrobromide and promethazine
Dextromethorphan hydrobromide 15 mg; promethazine hydrochloride 6.25 mg