Drugplain

Promethazine Hydrochloride and Dextromethorphan Hydrobromide 15 mg/5mL

Promethazine Hydrochloride and Dextromethorphan Hydrobromide · SOLUTION · Amneal Pharmaceuticals LLC

No Recall HistoryCurrently in Shortage
Plain English

This is a liquid medication that combines promethazine, an antihistamine used to treat allergies and nausea, with dextromethorphan, a cough suppressant. It is taken by mouth and requires a prescription from your doctor.

Key Facts

Brand Name
Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Generic Name
Promethazine Hydrochloride and Dextromethorphan Hydrobromide
NDC Code (Product)
65162-680
Manufacturer
Amneal Pharmaceuticals LLC
Strength
15 mg/5mL
Dosage Form
SOLUTION
Route
ORAL
Marketing Status
Application #
ANDA090575
Marketing Start
03/04/2011

Recall History

No Recall History

Side Effects Reported to FDA

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

colectomy1 reports
intestinal obstruction1 reports
neuropathy peripheral1 reports
product use in unapproved indication1 reports
somnolence1 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 Hydrochloride and Dextromethorphan Hydrobromide used for?

This is a liquid medication that combines promethazine, an antihistamine used to treat allergies and nausea, with dextromethorphan, a cough suppressant. It is taken by mouth and requires a prescription from your doctor.

Is Promethazine Hydrochloride and Dextromethorphan Hydrobromide a controlled substance?

Promethazine Hydrochloride and Dextromethorphan Hydrobromide is not classified as a controlled substance by the DEA.

What is the generic name for Promethazine Hydrochloride and Dextromethorphan Hydrobromide?

The generic name for Promethazine Hydrochloride and Dextromethorphan Hydrobromide is Promethazine Hydrochloride and Dextromethorphan Hydrobromide. There are 5 other brand versions of Promethazine Hydrochloride and Dextromethorphan Hydrobromide.

What is the NDC code for Promethazine Hydrochloride and Dextromethorphan Hydrobromide 15 mg/5mL?

The NDC (National Drug Code) for Promethazine Hydrochloride and Dextromethorphan Hydrobromide 15 mg/5mL is 65162-680, listed by Amneal Pharmaceuticals LLC.

Product NDC

65162-680

Package NDC

65162-680-86

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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