Promethazine Hydrochloride 6.25 mg/5mL Solution, 118 mL
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Phenothiazine class.
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🏭 Manufacturer & labeler
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🩺 Clinical
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 ↗- Promethazine has several uses. It's most commonly used for allergy symptoms like hay fever, hives, and itchy or watery eyes. It's also used to prevent or treat nausea and vomiting...
- Yes — drowsiness is the most common and expected side effect. You should avoid driving, operating machinery, or doing anything that requires sharp focus until you know how it affec...
- Will promethazine make me really drowsy?
- Promethazine is strictly off-limits for children under 2 years old — it can slow or stop breathing, and there have been fatalities reported in this age group. For children 2 and ol...
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Supplement & herbal interactions
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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 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.
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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.
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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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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.
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UNII Z8IX2SC1OH
Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
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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 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.
15 inactive ingredients listed in the exact product block matched to this NDC.
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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 | 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 | $7.74 / 118 ml |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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/5mLthis 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/5mL 72162-2377-02 | Bryant | 473 ml | — | AA | FDA listed | — |
| Promethazine Hydrochloride 6.25 mg/5mL 81033-0016-50 | Kesin | 50 cups | — | AA | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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💊 Medicaid utilization by pack size
🔬 Reported adverse events (FAERS)
Top reported reactions
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📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 70752-0138-06 You're viewing this | 118 mL in 1 BOTTLE, PLASTIC (70752-138-06) | — | — | 2021-07-12 | Active |
| 70752-0138-12 | 473 mL in 1 BOTTLE, PLASTIC (70752-138-12) | $0.0422 / mL | $19.95 | 2021-07-12 | Active |
You're viewing the smallest of 2 pack sizes for this product.
This pack shows little to no recent Medicaid volume — the 473 ml pack carries most fills. See all packs ↓
Pack size FAQ
What quantity is in NDC 70752-0138-06?
What is the difference between NDC 70752-0138-06 and NDC 70752-0138-12?
What NDC number is used to bill for this package of Promethazine Hydrochloride 6.25 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.
🧭 About this NDC listing & data coverage
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| 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. |
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
Promethazine 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 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 post-operative 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 ▾
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-Black Box 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 given on arising and again before the evening meal.
For children, Promethazine HCl Oral Solution, 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 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 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 by the oral route will provide sedation in children. Adults usually require 25 to 50 mg for nighttime, presurgical, or obstetrical sedation. Pre- and Postoperative Use Promethazine 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 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 ▾
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 ▾
WARNINGS Promethazine 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 (Promethazine HCl) 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 because of the potent…
🤒 Adverse Reactions ▾
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 ▾
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 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.
🤰 Pregnancy ▾
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.
🧒 Pediatric Use ▾
Pediatric Use Promethazine HCl Oral Solution are contraindicated for use in pediatric patients less than two years of age (see WARNINGS-Black Box 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 ▾
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 ▾
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 antiparkinsonian agents, diphenhydramine, or barbiturates.
Oxygen may also be administered. Limited experience with dialysis indicates that it is not helpful.
🧬 Clinical Pharmacology ▾
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-demethylpromethazine are the predominant metabolites appearing in the urine.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Promethazine HCl Oral Solution, USP 6.25 mg/5 mL is clear, green colored solution available in PET plastic bottles as follows: 4 fl oz (118 mL) NDC 70752-138-06 16 fl oz (473 mL) NDC 70752-138-12
📦 Storage and Handling ▾
STORAGE AND HANDLING Keep tightly closed. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature ] Protect from light. Dispense in light-resistant , tight container.
📋 Description ▾
DESCRIPTION Each 5 mL (teaspoonful) of Promethazine HCl Oral Solution contains 6.25 mg of Promethazine HCl. The inactive ingredients present are artificial banana flavor, artificial fruit flavor, artificial strawberry flavor, ascorbic acid, citric acid anhydrous, dehydrated alcohol, D&C Yellow No. 10, edetate disodium, FD&C Blue No.
1, FD&C Red No. 40, glycerin, sucrose, methylparaben, propylparaben, purified water, saccharin sodium, sodium benzoate, and sodium citrate dihydrate. Promethazine HCl is a racemic compound; the molecular formula is C 17 H 20 N 2 S•HCl and its molecular weight is 320.88.
Promethazine HCl, a phenothiazine derivative, is designated chemically as 10 H -Phenothiazine-10-ethanamine, N,N, α-trimethyl-, monohydrochloride, (±)- with the following structural formula: 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. Chemical Structure
💬 Information for Patients ▾
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. The 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 ).
Pediatric patients should be supervised to avoid potential harm in bike riding or in other hazardous activities. Patients should be advised to report any involuntary muscle movements. Avoid prolonged exposure to the sun.