Quick answers
- What is Promethazine hydrochloride and dextromethorphan hydrobromide used for?
- The FDA-approved label (Promethazine Hydrochloride and Dextromethorphan Hydrobromide, ANI Pharmaceuticals, Inc., August 8, 2025) says: “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.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Promethazine hydrochloride and dextromethorphan hydrobromide?
- The “Adverse Reactions” section of the FDA label (Promethazine Hydrochloride and Dextromethorphan Hydrobromide, ANI Pharmaceuticals, Inc., August 8, 2025) begins: “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.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the drug interactions of Promethazine hydrochloride and dextromethorphan hydrobromide?
- The “Drug Interactions” section of the FDA label (Promethazine Hydrochloride and Dextromethorphan Hydrobromide, ANI Pharmaceuticals, Inc., August 8, 2025) begins: “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.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Promethazine hydrochloride and dextromethorphan hydrobromide have a boxed warning?
- Yes. The FDA label for Promethazine Hydrochloride and Dextromethorphan Hydrobromide has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Promethazine hydrochloride and dextromethorphan hydrobromide?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Promethazine hydrochloride and dextromethorphan hydrobromide been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Promethazine hydrochloride and dextromethorphan hydrobromide?
- 14 companies list prescription products of Promethazine hydrochloride and dextromethorphan hydrobromide in the FDA NDC Directory, including A-S Medication Solutions, Atlantic Biologicals Corp. and Xttrium Laboratories, Inc.
What Promethazine hydrochloride and dextromethorphan hydrobromide is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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.
— FDA label: Promethazine Hydrochloride and Dextromethorphan Hydrobromide, ANI Pharmaceuticals, Inc., effective August 8, 2025. Read the full label on DailyMed →
Label quoted: the one for the most common form (solution, oral), Promethazine Hydrochloride and Dextromethorphan Hydrobromide, ANI Pharmaceuticals, Inc.; it covers 1 product in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
The FDA has 18 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
12 of 18 FDA labels for this medicine have a boxed warning.
Promethazine hydrochloride and dextromethorphan hydrobromide boxed warning: what the label says
Quoted from the boxed warning of the FDA-approved label.
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.
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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.
— FDA label: Promethazine Hydrochloride and Dextromethorphan Hydrobromide, ANI Pharmaceuticals, Inc., effective August 8, 2025. Read the full label on DailyMed →
Promethazine hydrochloride and dextromethorphan hydrobromide side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
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.
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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.
— FDA label: Promethazine Hydrochloride and Dextromethorphan Hydrobromide, ANI Pharmaceuticals, Inc., effective August 8, 2025. Read the full label on DailyMed →
Promethazine hydrochloride and dextromethorphan hydrobromide drug interactions
Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.
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.
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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.
— FDA label: Promethazine Hydrochloride and Dextromethorphan Hydrobromide, ANI Pharmaceuticals, Inc., effective August 8, 2025. Read the full label on DailyMed →
Promethazine hydrochloride and dextromethorphan hydrobromide dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
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.
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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.
— FDA label: Promethazine Hydrochloride and Dextromethorphan Hydrobromide, ANI Pharmaceuticals, Inc., effective August 8, 2025. Read the full label on DailyMed →
Promethazine hydrochloride and dextromethorphan hydrobromide in pregnancy
Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a 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.
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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.
— FDA label: Promethazine Hydrochloride and Dextromethorphan Hydrobromide, ANI Pharmaceuticals, Inc., effective August 8, 2025. Read the full label on DailyMed →
Promethazine hydrochloride and dextromethorphan hydrobromide and breastfeeding
Quoted from the nursing mothers / lactation part of the FDA-approved label.
It is not known whether promethazine or dextromethorphan is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
— FDA label: Promethazine Hydrochloride and Dextromethorphan Hydrobromide, ANI Pharmaceuticals, Inc., effective August 8, 2025. Read the full label on DailyMed →
When Promethazine hydrochloride and dextromethorphan hydrobromide should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
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.
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Dextromethorphan should not be used in patients receiving a monoamine oxidase inhibitor (see PRECAUTIONS – Drug Interactions).
— FDA label: Promethazine Hydrochloride and Dextromethorphan Hydrobromide, ANI Pharmaceuticals, Inc., effective August 8, 2025. Read the full label on DailyMed →
Promethazine hydrochloride and dextromethorphan hydrobromide overdose
Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).
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.
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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.
— FDA label: Promethazine Hydrochloride and Dextromethorphan Hydrobromide, ANI Pharmaceuticals, Inc., effective August 8, 2025. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Solution · Syrup |
|---|---|
| Route | Oral |
| Prescription products | 18 in the FDA NDC Directory |
| Brand names | Promethazine Dm |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| dextromethorphan hydrobromide 15 mg/5 mL · promethazine hydrochloride 6.25 mg/5 mL solution | Generic | $0.0398 per mL |
| dextromethorphan hydrobromide 15 mg/5 mL · promethazine hydrochloride 6.25 mg/5 mL syrup | Generic | $0.0398 per mL |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- A-S Medication Solutions4 products
- Atlantic Biologicals Corp.2 products
- Xttrium Laboratories, Inc.1 product
- Camber Pharmaceuticals, Inc.1 product
- Asclemed USA, Inc.1 product
- PAI Holdings, LLC dba PAI Pharma1 product
- ANI Pharmaceuticals, Inc.1 product
- Cosette Pharmaceuticals, Inc.1 product
- Advagen Pharma Ltd1 product
- Amneal Pharmaceuticals LLC1 product
- Bryant Ranch Prepack1 product
- NuCare Pharmaceuticals, Inc.1 product
- Cranbury Pharmaceuticals, LLC1 product
- Proficient Rx LP1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA011265 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | Ani Pharms | December 3, 1957 | 16, latest September 16, 2009 2009: Labeling · 2008: Manufacturing (CMC) · 2004: Labeling |
Generic approvals (6)
- ANDA088864Pharmobedient · January 4, 1985
- ANDA040649Pai Holdings · February 14, 2006
- ANDA090575Amneal Pharms · February 8, 2011
- ANDA091687Cosette Pharms Nc · June 28, 2012
- ANDA218264Hetero Labs Ltd III · March 12, 2026
- ANDA220869Rubicon Research · June 23, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 991528 |
|---|---|
| SPL set ID of the quoted label | a52e210f-b99d-493e-b679-ec565c6ff72d |
| FDA labels (SPL) | 18 |
| FDA applications | NDA011265, 6 ANDA |
| Active ingredients (FDA) | DEXTROMETHORPHAN / PROMETHAZINE |
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
- Latest FDA drug recallsAll medicines, newest first
- A-S Medication SolutionsMaker or distributor
- Atlantic Biologicals Corp.Maker or distributor
- Xttrium Laboratories, Inc.Maker or distributor
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Promethazine Hydrochloride and Dextromethorphan Hydrobromide, ANI Pharmaceuticals, Inc., effective August 8, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →