PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE

Each 5 mL (one teaspoonful), for oral administration contains: Promethazine hydrochloride 6.25 mg; phenylephrine hydrochloride 5 mg. Alcohol 7%. Inactive Ingredients: Apricot peach flavor, ascorbic acid, citric acid, FD&C yellow #6, menthol, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate and sucrose. Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as (±)-10-[2- (Dimethylamino)propyl] phenothiazine 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 C 17 H 20 N 2 S∙HCl, and the following structural formula: Phenylephrine hydrochloride is a sympathomimetic amine salt which is chemically designated as (-)-m- Hydroxy-α-[(methylamino)methyl] benzyl alcohol hydrochloride. It occurs as white or nearly white crystals, having a bitter taste. It is freely soluble in water and alcohol. Phenylephrine hydrochloride is subject to oxidation and must be protected from light and air. It has a molecular weight of 203.67, a molecular formula of C 9 H 13 NO 2 ∙HCl, and the following structural formula: Chemical Structure Chemical Structure

Promethazine hydrochloride and phenylephrine hydrochloride oral solution is indicated for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.

Promethazine hydrochloride and phenylephrine hydrochloride oral solution 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.

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. Phenylephrine is contraindicated in patients with hypertension or with peripheral vascular insufficiency (ischemia may result with risk of gangrene or thrombosis of compromised vascular beds). Phenylephrine should not be used in patients known to be hypersensitive to the drug or in those receiving a monoamine oxidase inhibitor (MAOI).

Promethazine 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 WARNINGS – Promethazine; Respiratory Depression .) Other – Angioneurotic edema. Neuroleptic malignant syndrome (potentially fatal) has also been reported. (See WARNINGS – Promethazine; 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. Phenylephrine Nervous System – Restlessness, anxiety, nervousness, and dizziness. Cardiovascular – Hypertension (see " WARNINGS "). Other – Precordial pain, respiratory distress, tremor, and weakness. To report SUSPECTED ADVERSE REACTIONS, contact Allucent at 1-866-511-6754 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Promethazine CNS Depressants Promethazine may increase, prolong, or intensify the sedative action of other central nervous system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine HCl. When given concomitantly with promethazine, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. Dosage must be individualized. Excessive amounts of promethazine HCl relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain. Epinephrine Because of the potential for promethazine to reverse epinephrine's vasopressor effect, epinephrine should NOT be used to treat hypotension associated with promethazine overdose. Anticholinergics Concomitant use of other agents with anticholinergic properties should be undertaken with caution. Monoamine Oxidase Inhibitors (MAOI) Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. Phenylephrine Drug Phenylephrine with prior administration of monoamine oxidase inhibitors (MAOI). Effect Cardiac pressor response potentiated. May cause acute hypertensive crisis. Drug Phenylephrine with tricyclic antidepressants. Effect Pressor response increased. Drug Phenylephrine with ergot alkaloids. Effect Excessive rise in blood pressure. Drug Phenylephrine with bronchodilator sympathomimetic agents and with epinephrine or other sympathomimetics. Effect Tachycardia or other arrhythmias may occur. Drug Phenylephrine with atropine sulfate. Effect Reflex bradycardia blocked; pressor response enhanced. Drug Phenylephrine with prior administration of propranolol or other β-adrenergic blockers. Effect Cardiostimulating effects blocked. Drug Phenylephrine with prior administration of phentolamine or other α-adrenergic blockers. Effect Pressor response decreased. Drug Phenylephrine with diet preparations, such as amphetamines or phenylpropanolamine. Effect Synergistic adrenergic response.

Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP.