Promethazine DM 15 mg/5mL

Promethazine Hydrochloride and Dextromethorphan Hydrobromide · SOLUTION · PAI Holdings, LLC dba PAI Pharma

1 Recall on RecordCurrently in Shortage

Plain English

Promethazine DM is a solution containing promethazine hydrochloride and dextromethorphan hydrobromide at 15 mg/5mL, taken oral. Manufactured by PAI Holdings, LLC dba PAI Pharma.

Key Facts

Brand Name: Promethazine DM
Generic Name: Promethazine Hydrochloride and Dextromethorphan Hydrobromide
NDC Code (Product): 0121-1070
Manufacturer: PAI Holdings, LLC dba PAI Pharma
Strength: 15 mg/5mL
Dosage Form: SOLUTION
Route: ORAL
Marketing Status
Application #: ANDA040649
Marketing Start: 06/04/2025

Recall History

1 Recall on Record

Class II02/23/2015

Qualitest Pharmaceuticals

Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

pain58 reports

nausea55 reports

fatigue53 reports

headache49 reports

diarrhoea45 reports

cough43 reports

dyspnoea41 reports

dizziness39 reports

anxiety35 reports

pneumonia33 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & 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 & Administration

DOSAGE AND ADMINISTRATION Promethazine hydrochloride and dextromethorphan hydrobromide oral solution is contraindicated for children under 2 years of age (see WARNINGS – Black Box Warning and Use In Pediatric Patients ). The average effective dose is given in the following table: Adults 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.

Warnings

WARNINGS WARNING: PROMETHAZINE HYDROCHLORIDE 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 HYDROCHLORIDE IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HYDROCHLORIDE HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HYDROCHLORIDE TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PROMETHAZINE HYDROCHLORIDE BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER AND CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH RESPIRATORY DEPRESSANT EFFECTS BE AVOIDED. Dextromethorphan: Administration of dextromethorphan may be accompanied by histamine release and should be used with caution in atopic children. 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…

Contraindications

CONTRAINDICATIONS Dextromethorphan should not be used in patients receiving a monoamine oxidase inhibitor (MAOI) (see PRECAUTIONS , Drug Interactions ). 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.

Drug Interactions

Drug Interactions Dextromethorphan: Hyperpyrexia, hypotension, and death have been reported coincident with the coadministration of monoamine oxidase (MAO) inhibitors and products containing dextromethorphan. Thus, concomitant administration of promethazine with dextromethorphan and MAO inhibitors should be avoided (see CONTRAINDICATIONS ). 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 – Beca…

Adverse Reactions

ADVERSE REACTIONS Dextromethorphan: Dextromethorphan hydrobromide occasionally causes slight drowsiness, dizziness, and gastrointestinal disturbances. 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 WARNING…

Frequently Asked Questions

What is Promethazine DM used for?

Promethazine DM contains Promethazine Hydrochloride and Dextromethorphan Hydrobromide. It is a solution taken oral. Consult your doctor for specific uses.

Is Promethazine DM a controlled substance?

Promethazine DM is not classified as a controlled substance by the DEA.

What is the generic name for Promethazine DM?

The generic name for Promethazine DM is Promethazine Hydrochloride and Dextromethorphan Hydrobromide. There are 11 other brand versions of Promethazine Hydrochloride and Dextromethorphan Hydrobromide.

What is the NDC code for Promethazine DM 15 mg/5mL?

The NDC (National Drug Code) for Promethazine DM 15 mg/5mL is 0121-1070, listed by PAI Holdings, LLC dba PAI Pharma.

Product NDC

0121-1070

Package NDC

0121-1070-04

Other Promethazine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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