Promethazine Hydrochloride and Dextromethorphan Hydrobromide 6.25 mg/5mL; 15 mg/5mL Solution, 473 mL
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Uncompetitive N-methyl-D-aspartate Receptor Antagonist class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
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Supplement & herbal interactions
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
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UNII XF417D3PSL
Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
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UNII PQ6CK8PD0R
Ascorbic acid, also known as vitamin C, is a white crystalline powder. It serves as an antioxidant to prevent degradation of other ingredients and may also function as a preservative in the formulation.
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UNII 35SW5USQ3G
A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
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UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
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UNII H77VEI93A8
A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
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UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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UNII BZ1R15MTK7
Levomenthol is the left-handed form of menthol, a natural cooling compound from mint plants. It's used in medicines as a flavoring agent and to provide a cooling sensation on the skin or mucous membranes.
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UNII SB8ZUX40TY
Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
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UNII OJ245FE5EU
Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
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UNII DK6Y9P42IN
Sodium propionate is a salt derived from propionic acid. It's added to medicines as a preservative to prevent bacterial and fungal growth, helping extend shelf life.
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UNII C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
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UNII B22547B95K
A salt derived from citric acid that helps maintain the proper acid-base balance in the medicine. It's used as a buffer to keep the product stable and at the right pH level.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
14 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.038 | $18.16 / 473 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.0874 | $41.34 / 473 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
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⏳ Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
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🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 62559-0758-04 | 118 mL in 1 BOTTLE (62559-758-04) | — | — | 2024-09-05 | Active |
| 62559-0758-16 You're viewing this | 473 mL in 1 BOTTLE (62559-758-16) | $0.0384 / mL | $18.18 | 2024-09-05 | Active |
You're viewing the largest of 2 pack sizes for this product.
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 62559-0758-16?
What is the difference between NDC 62559-0758-16 and NDC 62559-0758-04?
What NDC number is used to bill for this package of Promethazine Hydrochloride and Dextromethorphan Hydrobromide 6.25 mg/5mL; 15 mg/5mL Solution?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution should not be used in pediatric patients less than 2 years of age because of the potential for fatal respiratory depression. Postmarketing cases of respiratory depression, including fatalities, have been reported with use of promethazine in pediatric patients less than 2 years of age. A wide range of weight-based doses of promethazine have resulted in respiratory depression in these patients.
Caution should be exercised when administering promethazine to pediatric patients 2 years of age and older. It is recommended that the lowest effective dose of promethazine be used in pediatric patients 2 years of age and older and concomitant administration of other drugs with respiratory depressant effects be avoided.
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION It is important that Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution is measured with an accurate measuring device (see PRECAUTIONS – Information for Patients ). A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when half a teaspoon is to be measured. It is strongly recommended that an accurate measuring device be used.
A pharmacist can provide an appropriate device and can provide instructions for measuring the correct dose. Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution is CONTRAINDICATED for children under 2 years of age (see WARNINGS – Boxed Warning and Use in Pediatric Patients ). The average effective dose for adults is 5 mL (one teaspoon) every 4 to 6 hours, not to exceed 30.0 mL in 24 hours.
For children 6 years to under 12 years of age, the dose is 2.5 to 5.0 mL (one-half to one teaspoon) every 4 to 6 hours, not to exceed 20.0 mL in 24 hours. For children 2 years to under 6 years of age, the dose is 1.25 to 2.5 mL (one-quarter to one-half teaspoon) every 4 to 6 hours, not to exceed 10.0 mL in 24 hours.
⛔ Contraindications ▾
CONTRAINDICATIONS Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution is contraindicated for use in pediatric patients less than two years of age. 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.
Dextromethorphan should not be used in patients receiving a monoamine oxidase inhibitor (see PRECAUTIONS – Drug Interactions ).
⚠️ Warnings ▾
WARNINGS Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution should not be used in pediatric patients less than 2 years of age because of the potential for fatal respiratory depression. Postmarketing cases of respiratory depression, including fatalities, have been reported with use of promethazine in pediatric patients less than 2 years of age. A wide range of weight-based doses of promethazine have resulted in respiratory depression in these patients.
Caution should be exercised when administering promethazine to pediatric patients 2 years of age and older. It is recommended that the lowest effective dose of promethazine be used in pediatric patients 2 years of age and older and concomitant administration of other drugs with respiratory depressant effects be avoided. PROMETHAZINE CNS Depression Promethazine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery.
The impairment may be amplified by concomitant use 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 either be eliminated or given in reduced dosage in the presence of promethazine (see PRECAUTIONS – Information for Patients and Drug Interactions ). Respiratory Depression Promethazine may lead to potentially fatal respiratory depression.
Use of Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution in patients with compromised respiratory function (e.g. COPD, sleep apnea syndrome) should be avoided. Lower Seizure Threshold Promethazine may lower seizure threshold.
It should be used with caution in persons with seizure disorders or in persons who are using concomitant medications, such as narcotics or local anesthetics, which may also affect seizure threshold. Bone-Marrow Depression Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution should be used with caution in patients with bone-marrow depression. Leukopenia and agranulocytosis have been reported, usually when promethazine has been used in association with other known marrow-toxic agents.
Neuroleptic Malignant Syndrome A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with promethazine alone or in combination with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmias). The diagnostic evaluation of patients with this syndrome is complicated.
In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g. pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology. The management of NMS should include 1) immediate discontinuation of promethazine, antipsychotic drugs, if any, and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available.
There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS. Since recurrences of NMS have been reported with phenothiazines, the reintroduction of promethazine should be carefully considered. Use in Pediatric Patients Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution is contraindicated for use in pediatric patients less than two years of age.
Caution should be e…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS 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 – Respiratory Depression .) Other – Angioneurotic edema. Neuroleptic malignant syndrome (potentially fatal) has also been reported (see WARNINGS – Neuroleptic Malignant Syndrome .) Paradoxical Reactions Hyperexcitability and abnormal movements have been reported in patients following a single administration of Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution.
Consideration should be given to the discontinuation of promethazine Hydrochloride 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. DEXTROMETHORPHAN Dextromethorphan occasionally causes slight drowsiness, dizziness, and gastrointestinal disturbances.
To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🔄 Drug Interactions ▾
Drug Interactions Monoamine Oxidase (MAO) Inhibitors – Hyperpyrexia, hypotension, and death have been reported coincident with the co-administration of monoamine oxidase (MAO) inhibitors and products containing dextromethorphan. Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAO inhibitors and phenothiazines are used concomitantly. Thus, concomitant administration of Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution and MAO inhibitors should be avoided (see CONTRAINDICATIONS ).
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. When given concomitantly with Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution, 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 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 Hydrochloride and Dextromethorphan Hydrobromide Oral Solution overdose.
Anticholinergics – Concomitant use of other agents with anticholinergic properties should be undertaken with caution.
🔄 Drug / Laboratory Test Interactions ▾
Drug/Laboratory Test Interactions The following laboratory tests may be affected in patients who are receiving therapy with promethazine: Pregnancy Tests Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations. Glucose Tolerance Test An increase in blood glucose has been reported in patients receiving promethazine.
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine. These doses are 8.3 and 16.7 times the maximum recommended total daily dose for a 50-kg subject. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats.
Specific studies to test the action of promethazine on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. Although antihistamines, including promethazine, have been found to produce fetal mortality in rodents, the pharmacological effects of histamine in the rodent do not parallel those in man. There are no adequate and well-controlled studies of promethazine in pregnant women.
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 Hydrochloride and Dextromethorphan Hydrobromide Oral Solution should be given to a pregnant woman only if clearly needed.
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects Promethazine administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn.
🧒 Pediatric Use ▾
Pediatric Use Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution is contraindicated for use in pediatric patients less than two years of age (see WARNINGS – Boxed Warning and Use in Pediatric Patients ) . Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution should be used with caution in pediatric patients 2 years of age and older (see WARNINGS – Use in Pediatric Patients ).
🧓 Geriatric Use ▾
Geriatric Use Clinical studies of promethazine formulations did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution and observed closely.
🆘 Overdosage ▾
OVERDOSAGE PROMETHAZINE Signs and symptoms of overdosage with promethazine 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.
DEXTROMETHORPHAN Dextromethorphan may produce central excitement and mental confusion. Very high doses may produce respiratory depression. One case of toxic psychosis (hyperactivity, marked visual and auditory hallucinations) after ingestion of a single dose of 20 tablets (300 mg) of dextromethorphan has been reported.
Treatment Treatment of overdosage with Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution is essentially symptomatic and supportive. Only in cases of extreme overdosage or individual sensitivity do vital signs, including respiration, pulse, blood pressure, temperature, and EKG, need to be monitored. Activated charcoal orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic.
Attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. Diazepam may be used to control convulsions. Acidosis and electrolyte losses should be corrected.
The antidotal efficacy of narcotic antagonists to dextromethorphan has not been established; note that any of the depressant effects of promethazine are not reversed by naloxone. Avoid analeptics, which may cause convulsions. The treatment of choice for resulting hypotension is administration of intravenous fluids, accompanied by repositioning if indicated.
In the event that vasopressors are considered for the management of severe hypotension which does not respond to intravenous fluids and repositioning, the administration of norepinephrine or phenylephrine should be considered. EPINEPHRINE SHOULD NOT BE USED, since its use in a patient with partial adrenergic blockade may further lower the blood pressure. Extrapyramidal reactions may be treated with anticholinergic antiparkinson agents, diphenhydramine, or barbiturates.
Oxygen may also be administered. Limited experience with dialysis indicates that it is not helpful.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY PROMETHAZINE 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 H 1 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. DEXTROMETHORPHAN Dextromethorphan is an antitussive agent and, unlike the isomeric levorphanol, it has no analgesic or addictive properties. Dextromethorphan acts centrally and elevates the threshold for coughing.
It is about equal to codeine in depressing the cough reflex. In therapeutic dosage dextromethorphan does not inhibit ciliary activity. Dextromethorphan is rapidly absorbed from the gastrointestinal tract and exerts its effect in 15 to 30 minutes.
The duration of action after oral administration is approximately three to six hours. Dextromethorphan is metabolized primarily by liver enzymes undergoing O-demethylation, N-demethylation, and partial conjugation with glucuronic acid and sulfate. In humans, (+)-3-hydroxy-N-methylmorphinan, (+)-3-hydroxymorphinan, and traces of unmetabolized drug were found in urine after oral administration.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution is a clear, yellow solution supplied as follows: NDC 62559-758-04 – bottle of 4 fl. oz. (118 mL) NDC 62559-758-16 – bottle of 16 fl. oz. (473 mL) Keep bottles tightly closed.
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from light. Dispense in tight, light-resistant container (USP/NF) with a child-resistant closure.
Distributed by ANI Pharmaceuticals, Inc. Baudette, MN 56623 Issued: 04/2025 LB4688-02 ANI-logo
📋 Description ▾
DESCRIPTION Each 5 mL (teaspoon) of Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution contains 6.25 mg promethazine hydrochloride USP and 15 mg dextromethorphan hydrobromide USP in a flavored syrup base with a pH between 4.5 and 5.5. The inactive ingredients present are alcohol 7% (v/v), ascorbic acid, citric acid, black currant flavor, D&C Yellow 10, edetate disodium, FD&C Yellow 6, glycerin, L-Menthol, sodium benzoate, sodium citrate, sodium propionate, saccharin sodium, sucrose, and water.
Promethazine hydrochloride USP is a racemic compound; the empirical formula is C 17 H 20 N 2 S•HCl and its molecular weight is 320.88. Promethazine hydrochloride USP, a phenothiazine derivative, is chemically designated as 10 H -Phenothiazine-10-ethanamine, N , N , α-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.
Dextromethorphan hydrobromide USP 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 with the following structural formula: Dextromethorphan hydrobromide monohydrate occurs as white crystals, is sparingly soluble in water, and is freely soluble in alcohol. The empirical formula is C 18 H 25 NO•HBr•H 2 O, and the molecular weight of the monohydrate is 370.33.
Dextromethorphan hydrobromide monohydrate is dextrorotatory with a specific rotation of +27.6 degrees in water (20 degrees C, sodium D-line). Prometh_structure.jpg Dextro_structure.jpg
💬 Information for Patients ▾
Information for Patients Patients should be advised to measure Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution with an accurate measuring device. A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when a half a teaspoon is measured. A pharmacist can recommend an appropriate measuring device and can provide instructions for measuring the correct dose.
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution may cause marked drowsiness or impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. Ambulatory patients should be told to avoid engaging in such activities until it is known that they do not become drowsy or dizzy from promethazine and dextromethorphan therapy. Pediatric patients should be supervised to avoid potential harm in bike riding or in other hazardous activities.
The concomitant use of alcohol or other central-nervous-system depressants, such as sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers, may enhance impairment (see WARNINGS – CNS Depression and PRECAUTIONS – Drug Interactions ). Patients should be advised to report any involuntary muscle movements. Avoid prolonged exposure to the sun.