Home › NDC Lookup › Ingredients › Promethazine Hydrochloride › 72162-2377-02
PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL Solution, 473 mL — NDC 72162-2377-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL Solution, 473 mL — NDC 72162-2377-2 (Billing 72162-2377-02)

by Bryant Ranch Prepack · 473 mL in 1 BOTTLE

This is a package of 473 mL of PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL Solution from Bryant Ranch Prepack, marketed since Feb 2024 and currently FDA-listed. It is this product's only package size.

NDC 72162-2377-02
🏷️ FDA NDC (as labeled) 72162-2377-2 billing pads the package segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 72162-2377-2 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
72162 labeler · 2377 product · 2 package
Package marketed since
Jul 30, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
473 mL per package
Barcode (UPC-A, from the NDC)
3 7216223772 4
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 72162-2377-2
Product NDC 72162-2377
11-digit billing NDC 72162237702
NCPDP billing unit ML — per mL (volume)
RxCUI 992432
UNII R61ZEH7I1I
Application # ANDA040891
SPL Set ID a4b3da5b-1129-43c2-bf22-3a29c3fae116
Established class (EPC) Phenothiazine
Chemical class Phenothiazines
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-02-20
Route ORAL
Dosage form SOLUTION
Substance PROMETHAZINE HYDROCHLORIDE
TE code (Orange Book) AA · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 003876
GCN 15035
HICL code 012014
Ingredient (HICL) Promethazine Hcl
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z2
Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code Z2P
Therapeutic class — specific (HIC3) Antihistamines - 1St Generation
AHFS code 04:04.12.00
AHFS class Phenothiazine Derivatives
FDB label name PROMETHAZINE 6.25 MG/5 ML SOLN
FDB brand name Promethazine Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 003876
  • GCN: 15035
  • HICL (First Databank): 012014
  • AHFS class code: 04:04.12.00
  • RxCUI (RxNorm): 992432
Why two NDCs? The FDA registers this code as 72162-2377-2 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 72162-2377-02. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Phenothiazine class.

Pharmacologic class Phenothiazine
Drug family (ATC) Antihistamines for topical use, Phenothiazine derivatives
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name PROMETHAZINE 6.25 MG/5 ML SOLN Ingredient Promethazine Hcl
📖 What it is MedlinePlus · NLM

Promethazine is used to relieve the symptoms of allergic reactions such as allergic rhinitis (runny nose and watery eyes caused by allergy to pollen, mold or dust), allergic conjunctivitis (red, watery eyes caused by allergies), allergic skin reactions, and allergic reactions to blood or plasma products. Promethazine is used with other medications to treat anaphylaxis (sudden, severe allergic reactions) and the symptoms of the common cold such as sneezing, cough, and runny nose. Promethazine is also used to relax and sedate patients before and after surgery, during labor, and at other times. P...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats allergy symptoms like allergic rhinitis and hives, motion sickness, and nausea and vomiting around surgery. It is also used for sedation. Which uses apply depends on the...
  • Very likely. Drowsiness is its most common effect. Don't drive or use machinery until you know how it affects you, and avoid alcohol and other sedating medicines.
  • Not if the child is under 2. It can cause fatal slowed breathing in that age group. For children 2 and older, it needs real caution and the lowest effective dose, so only use it as...
  • Use an accurate measuring device, not a kitchen teaspoon, which can lead to overdose. I can give you an oral syringe or dosing cup and show you how to measure.
📖 Read our full Promethazine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.0656 $31.03 / 473 ml
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
72162-2377-02 You're viewing this Main listing 473 mL in 1 BOTTLE 2024-07-30 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Promethazine Hydrochloride 6.25 mg/5mL 00116-4023-16 Xttrium 473 ml $0.042 AA Availability likely —
Promethazine Hydrochloride 6.25 mg/5mL 00121-1854-16 PAI 473 ml $0.042 AA Availability likely —
promethazine hydrochloride 6.25 mg/5mL 27808-0051-02 Cranbury 473 ml $0.042 AA Availability likely —
promethazine hydrochloride 6.25 mg/5mL 17856-0059-01 ATLANTIC 72 cups — AA FDA listed —
Promethazine Hydrochloride 6.25 mg/5mL 17856-4023-01 Atlantic 72 cups — AA FDA listed —
Promethazine Hydrochloride 6.25 mg/5mL 29033-0500-34 Nostrum 473 ml — AA Discontinued —
promethazine hydrochloride 6.25 mg/5mL 50090-6431-00 A-S 473 ml — AA FDA listed —
Promethazine Hydrochloride 6.25 mg/5mL 62135-0774-41 Chartwell 120 ml — AA FDA listed —
Promethazine Hydrochloride 6.25 mg/5mL 68999-0774-23 Chartwell 10 cups — AA FDA listed —
Promethazine Hydrochloride 6.25 mg/5mL 70752-0138-06 QUAGEN 118 ml — AA FDA listed —
Promethazine Hydrochloride 6.25 mg/5mL 72162-2071-02 Bryant 473 ml — AA FDA listed —
Promethazine Hydrochloride 6.25 mg/5mLthis 72162-2377-02 Bryant 473 ml — AA FDA listed —
Promethazine Hydrochloride 6.25 mg/5mL 81033-0016-50 Kesin 50 cups — AA FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2024
On the market since
Feb 2024
📍
2026
Currently FDA-listed
2 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color Green
FlavorPineapple
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

🧪 Avoiding an ingredient? See Promethazine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • 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.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • 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.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • 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.
  • 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?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerBryant Ranch Prepack
Application holderSTRIDES PHARMA GLOBAL PTE LTD
FDA applicationANDA040891 (ANDA)
Labeler code72162
First marketedFeb 2024
Product typeHuman Prescription Drug
Portfolio4,436 products on file

More NDCs from Bryant Ranch Prepack labeler code 72162

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🔄 Drug / Laboratory Test Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 113 words ▾

Promethazine HCl 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 130 words ▾

INDICATIONS AND USAGE Promethazine HCl Oral Solution is useful for: Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods.

Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism.

Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.

Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness.

Antiemetic therapy in postoperative patients.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION It is important that Promethazine HCl 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 HCl Oral Solution is contraindicated for children under 2 years of age ( see WARNINGS – Boxed Warning and Use in Pediatric Patients ). Allergy The average oral dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary.

Single 25 mg doses at bedtime or 6.25 to 12.5 mg taken three times daily will usually suffice. After initiation of treatment in children or adults, dosage should be adjusted to the smallest amount adequate to relieve symptoms. The administration of promethazine HCl in 25 mg doses will control minor transfusion reactions of an allergic nature.

Motion Sickness The average adult dose is 25 mg taken twice daily. The initial dose should be taken one-half to one hour before anticipated travel and be repeated 8 to 12 hours later, if necessary. On succeeding days of travel, it is recommended that 25 mg be taken on arising and again before the evening meal.

For children, 12.5 to 25 mg, twice daily, may be administered. Nausea and Vomiting Antiemetics should not be used in vomiting of unknown etiology in children and adolescents (see WARNINGS- Use in Pediatric Patients ). The average effective dose of Promethazine HCl Oral Solution for the active therapy of nausea and vomiting in children or adults is 25 mg.

When oral medication cannot be tolerated, the dose should be given parenterally (cf. Promethazine Hydrochloride Injection) or by rectal suppository. 12.5 to 25 mg doses may be repeated, as necessary, at 4 to 6 hour intervals.

For nausea and vomiting in children, the usual dose is 0.5 mg per pound of body weight, and the dose should be adjusted to the age and weight of the patient and the severity of the condition being treated. For prophylaxis of nausea and vomiting, as during surgery and the postoperative period, the average dose is 25 mg repeated at 4 to 6 hour intervals, as necessary. Sedation This product relieves apprehension and induces a quiet sleep from which the patient can be easily aroused.

Administration of 12.5 to 25 mg Promethazine HCl Oral Solution by the oral route at bedtime will provide sedation in children. Adults usually require 25 to 50 mg for nighttime, presurgical, or obstetrical sedation. Pre- and Postoperative Use Promethazine HCl Oral Solution in 12.5 to 25 mg doses for children and 50 mg doses for adults the night before surgery relieves apprehension and produces a quiet sleep.

For preoperative medication children require doses of 0.5 mg per pound of body weight in combination with an appropriately reduced dose of narcotic or barbiturate and the appropriate dose of an atropine-like drug. Usual adult dosage is 50 mg Promethazine HCl Oral Solution with an appropriately reduced dose of narcotic or barbiturate and the required amount of a belladonna alkaloid. Postoperative sedation and adjunctive use with analgesics may be obtained by the administration of 12.5 to 25 mg in children and 25 to 50 mg doses in adults.

Promethazine HCl Oral Solution is contraindicated for children under 2 years of age.

⛔ Contraindications 62 words ▾

CONTRAINDICATIONS Promethazine HCl Oral Solution is contraindicated for use in pediatric patients less than two years of age. Promethazine HCl Oral Solution 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.

⚠️ Warnings ~3 min read ▾

WARNINGS Promethazine HCl 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. CNS Depression Promethazine HCl Oral Solution 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 HCl (see PRECAUTIONS – Information for Patients and Drug Interactions ). Respiratory Depression Promethazine HCl Oral Solution may lead to potentially fatal respiratory depression.

Use of Promethazine HCl Oral Solution in patients with compromised respiratory function (e.g. COPD, sleep apnea) should be avoided. Lower Seizure Threshold Promethazine HCl Oral Solution 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 HCl Oral Solution should be used with caution in patients with bone-marrow depression. Leukopenia and agranulocytosis have been reported, usually when Promethazine HCl Oral Solution 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 HCl 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 HCl, 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 HCl should be carefully considered. Use in Pediatric Patients Promethazine HCl Oral Solution is contraindicated for use in pediatric patients less than two years of age.

Caution should be exercised when administering Promethazine HCl Oral Solution to pediatric patients 2 years of age and older bec… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions 171 words ▾

ADVERSE REACTIONS 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 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.

🔄 Drug Interactions 198 words ▾

Drug Interactions CNS Depressants – Promethazine HCl Oral Solution 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 HCl 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 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 HCl Oral Solution to reverse epinephrine’s vasopressor effect, epinephrine should NOT be used to treat hypotension associated with Promethazine HCl Oral Solution 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. This possibility should be considered with Promethazine HCl Oral Solution.

🔄 Drug / Laboratory Test Interactions 55 words ▾

Drug/Laboratory Test Interactions The following laboratory tests may be affected in patients who are receiving therapy with promethazine HCl: 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 HCl.

🤰 Pregnancy 188 words ▾

Pregnancy Teratogenic Effects-Pregnancy Category C Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine HCl. These doses are from approximately 2.1 to 4.2 times the maximum recommended total daily dose of promethazine for a 50-kg subject, depending upon the indication for which the drug is prescribed. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats.

Specific studies to test the action of the drug 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 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 HCl Oral Solution in pregnant women.

Promethazine HCl Oral Solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects Promethazine HCl Oral Solution administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn.

🧒 Pediatric Use 54 words ▾

Pediatric Use Promethazine HCl 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 HCl Oral Solution should be used with caution in pediatric patients 2 years of age and older (see WARNINGS-Use in Pediatric Patients ).

🧓 Geriatric Use 110 words ▾

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 HCl Oral Solution and observed closely.

🆘 Overdosage ~1 min read ▾

OVERDOSAGE Signs and symptoms of overdosage with promethazine HCl 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.

Treatment Treatment of overdosage 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.

Note that any depressant effects of promethazine HCl 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 patients 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 127 words ▾

CLINICAL PHARMACOLOGY 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-desmethylpromethazine are the predominant metabolites appearing in the urine.

📦 How Supplied / Storage and Handling 82 words ▾

HOW SUPPLIED Promethazine Hydrochloride Oral Solution USP, 6.25 mg/5 mL, is a clear, green oral solution supplied as follows: NDC: 72162-2377-2: Bottle of 16 fl. oz. (473 mL) with a child-resistance cap. Keep bottles tightly closed.

This package is child-resistant. Keep out of reach of children. Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Protect from light.

Dispense in a tight, light-resistant container (USP/NF) with a child-resistant closure. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

📋 Description 141 words ▾

DESCRIPTION Each teaspoonful (5 mL) of Promethazine HCl Oral Solution contains 6.25 mg promethazine HCl in a flavored syrup base with a pH between 4.7 and 5.2. Alcohol 7%. The inactive ingredients present are ascorbic acid, citric acid, D&C Yellow No.

10, edetate disodium, ethyl alcohol, FD&C Blue No. 1, FD&C Red No. 40, glycerin, methylparaben, pineapple flavor, purified water, sodium benzoate, sodium citrate, sucralose, and sucrose.

Promethazine HCl is a racemic compound; the molecular formula is C 17 H 20 N 2 S•HCl and its molecular weight is 320.89. Promethazine HCl, a phenothiazine derivative, is chemically designated as 10-[2- (Dimethylamino)propyl] phenothiazine monohydrochloride. Its structural formula is: Promethazine HCl 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.

💬 Information for Patients 192 words ▾

Information for Patients Patients should be advised to measure Promethazine HCl 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 HCl 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 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.

A patient information leaflet is included and summarizes important information about promethazine.

💬 Medication Guide ~3 min read ▾

PATIENT INFORMATION LEAFLET PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION USP 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, 6.25 mg per 5 mL) Rx Only What Is Promethazine HCl Oral Solution? Promethazine is an antihistamine which can be taken by mouth as an oral solution or tablet, rectally as a suppository, or by injection. It can be used for: “hay fever,” or, a stuffy runny nose from allergy watery, itchy eyes due to inhaled allergies and foods mild allergic skin reactions with itching and swelling allergic reactions to blood or plasma dermographism, a form of hives known as “skin writing” serious allergic reactions along with epinephrine and other treatments sedation before or after surgery, or during childbirth prevention and control of nausea and vomiting after surgery along with meperidine (demerol) or other pain medicines sedation, relief of anxiety, and production of light sleep from which the patient can be easily aroused treatment and prevention of motion sickness Who Should Not Use Promethazine HCl Oral Solution?

Promethazine should not be given to: children under two years of age patients who are unconscious patients who are allergic to promethazine, any of the ingredients in promethazine, or to other phenothiazines patients with lung symptoms including asthma children who are vomiting unless the vomiting is prolonged and there is a known cause What Are The Risks? The following are the major potential risks and side effects of Promethazine HCl Oral Solution therapy. However, this list is not complete.

Severe drowsiness and reduced mental alertness. Promethazine HCl Oral Solution may cause drowsiness which may impair your ability to ride a bike, drive a car, or operate machinery. This may be worsened if taken with alcohol or other drugs that also cause central nervous system (CNS) slowing such as sedatives, pain medicines, tranquilizers or certain drugs for depression.

Serious breathing problems. Promethazine HCl Oral Solution should not be used in patients with poor lung function such as chronic obstructive lung disease or breathing problems while sleeping (sleep apnea.) Increased risk of seizures. Promethazine HCl Oral Solution should be used with caution in patients with seizures or who are on other medicines which may also increase the risk of seizures.

Bone-marrow problems and blood cell production . Promethazine HCl Oral Solution should not be used in patients with bone-marrow problems or used with other drugs that affect the bone marrow's production of blood cells. Neuroleptic malignant syndrome .

This potentially deadly syndrome includes symptoms such as fever, muscle rigidity, mental changes, changes in pulse or blood pressure, fast heartbeat, increased sweating or irregular heart rhythm. The most common side effects are drowsiness, changes in blood pressure, skin reactions, blood cell changes and breathing problems. Increased excitability or abnormal movements may occur after one dose of promethazine.

If they do, consult your doctor about using another medicine. What Should I Tell My Healthcare Professional? Before you start taking Promethazine HCl Oral Solution , tell your healthcare professional if you: have narrow-angle glaucoma have an enlarged prostate have a stomach ulcer have an intestinal blockage have a bladder blockage have heart problems have liver problems have breathing or lung problems have sleep apnea (breathing problems when sleeping) have seizures drink alcohol are trying to become pregnant, are already pregnant, or are breast-feeding Can Other Medicines Or Food Affect Promethazine?

Promethazine HCl Oral Solution and certain other medicines can interact with each other. Tell your healthcare professional about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may affect how promethazine works or promethazine may affect how your other medicines work.

Know the medicines you take. Keep a list of them with you to show… [Excerpted — this section continues on DailyMed.]

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General Drugs having anticholinergic properties should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, and bladder-neck obstruction. Promethazine HCl Oral Solution should be used cautiously in persons with cardiovascular disease or with impairment of liver function. Information for Patients Patients should be advised to measure Promethazine HCl 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 HCl 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 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. A patient information leaflet is included and summarizes important information about promethazine.

Drug Interactions CNS Depressants – Promethazine HCl Oral Solution 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 HCl 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 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 HCl Oral Solution to reverse epinephrine’s vasopressor effect, epinephrine should NOT be used to treat hypotension associated with Promethazine HCl Oral Solution 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. This possibility should be considered with Promethazine HCl Oral Solution.

Drug/Laboratory Test Interactions The following laboratory tests may be affected in patients who are receiving therapy with promethazine HCl: 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 HCl. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to assess the carcinogenic potential of promethazine, nor are there other animal or human data concerning carginogenicity, mutagenicity, or impairment of fertility with this drug.

Promethazine was nonmutagenic in the Salmonella… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 64 words ▾

Nursing Mothers It is not known whether promethazine HCl 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 HCl 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.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 47 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to assess the carcinogenic potential of promethazine, nor are there other animal or human data concerning carginogenicity, mutagenicity, or impairment of fertility with this drug. Promethazine was nonmutagenic in the Salmonella test system of Ames.

📄 Package Label / Principal Display Panel 6 words ▾

Promethazine HCl 6.25mg/5mL Sol #473 Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Bryant Ranch Prepack. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Bryant Ranch Prepack is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 72162-2376-02 · Bryant 72162-2379-03 · Bryant →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.