Hydroxyzine Hydrochloride 10 mg/5mL Solution, 473 mL
Other active recalls for Hydroxyzine Hydrochloride (different manufacturers) — 1 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Antihistamine class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Hydroxyzine is used to relieve itching caused by allergic skin reactions, to relieve anxiety and tension, and as a sedative before and after general anesthesia for surgery. Hydroxyzine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. It also works by decreasing activity in the brain.
Read the full MedlinePlus article ↗- Hydroxyzine is most often used to relieve anxiety and tension, or to control itching from allergic conditions like hives or eczema. It's also used as a calming medication before su...
- Drowsiness is the most common side effect — it's actually how the medication works, so some sleepiness is expected, especially when you first start. For most people it gets better...
- This is really important to go over with your pharmacist or doctor, because hydroxyzine interacts with a number of common drugs. Combining it with alcohol, opioid pain medicines, s...
- Can I take hydroxyzine with my other medications?
Patient education
Supplement & herbal interactions
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💊 What it looks like
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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 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 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 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.
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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 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.
5 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
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 | $0.109 | $51.51 / 473 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.1672 | $79.09 / 473 ml |
| Medicare drug plans payPart D · Q2 2026 | $0.1500 | $70.95 / 473 ml |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Hydroxyzine Hydrochloride 10 mg/5mL 00121-1034-16 | PAI | 473 ml | $0.109 | AA | Availability likely | — |
| Hydroxyzine Hydrochloride 10 mg/5mLthis 54838-0502-80 | Lannett | 473 ml | $0.109 | AA | Availability likely | — |
| Hydroxyzine Hydrochloride 10 mg/5mL 62135-0502-47 | Chartwell | 473 ml | $0.109 | AA | Availability likely | — |
| Hydroxyzine Hydrochloride 10 mg/5mL 62135-0750-47 | Chartwell | 473 ml | $0.109 | AA | Availability likely | — |
| Hydroxyzine Hydrochloride 10 mg/5mL 69452-0395-88 | Bionpharma | 473 ml | $0.109 | AA | Availability likely | — |
| Hydroxyzine Hydrochloride 10 mg/5mL 70954-0912-10 | ANI | 473 ml | $0.109 | AA | Availability likely | — |
| Hydroxyzine Hydrochloride 10 mg/5mL 83745-0232-16 | APOZEAL | 473 ml | $0.109 | AA | Availability likely | — |
| Hydroxyzine Hydrochloride 10 mg/5mL 17856-0507-01 | ATLANTIC | 72 cups | — | AA | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg/25mL 62135-0050-24 | Chartwell | 10 cups | — | AA | FDA listed | — |
| Hydroxyzine Hydrochloride 10 mg/5mL 63187-0494-04 | Proficient | 118 ml | — | AA | FDA listed | — |
| Hydroxyzine Hydrochloride 50 mg/25mL 68999-0050-24 | Chartwell | 10 cups | — | AA | FDA listed | — |
| Hydroxyzine Hydrochloride 10 mg/5mL 71656-0090-16 | Saptalis | 473 ml | — | AA | FDA listed | — |
| Hydroxyzine Hydrochloride 10 mg/5mL 81033-0031-44 | Kesin | 40 cups | — | AA | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
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?
🗺️ Medicaid utilization & spend
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 54838-0502-80 You're viewing this | 473 mL in 1 BOTTLE, PLASTIC (54838-502-80) | 2013-08-21 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus. As a sedative when used in premedication and following general anesthesia, Hydroxyzine may potentiate meperidine (Demerol ® ) and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis.
Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies.
The physician should reassess periodically the usefulness of the drug for the individual patient.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested: in adults, 50 to 100 mg four times daily.: children under 6 years, 50 mg daily in divided doses: children over 6 years: 50 to 100 mg daily in divided doses. For use in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus: in adults, 25 mg three times to four times daily.; children under 6 years, 50 mg daily in divided doses and children over 6 years, 50 to 100 mg daily in divided doses.
As a sedative when used as a premedication and following general anesthesia: 50 to 100 mg in adults, and 0.6 mg/kg in children. When treatment is initiated by the intramuscular route of administration, subsequent doses may be administered orally. As with all medications, the dosage should be adjusted according to the patient’s response to therapy.
⛔ Contraindications ▾
CONTRAINDICATIONS Oral hydroxyzine hydrochloride is contraindicated in patients with known hypersensitivity to hydroxyzine hydrochloride products, and in patients with known hypersensitivity to cetirizine hydrochloride or levocetirizine hydrochloride. Hydroxyzine is contraindicated in patients with a prolonged QT interval. Hydroxyzine, when administered to the pregnant mouse, rat and rabbit, induced fetal abnormalities in the rat and mouse at doses substantially above the human therapeutic range.
Clinical data in human beings are inadequate to establish safety in early pregnancy. Until such data are available, hydroxyzine is contraindicated in early pregnancy. Hydroxyzine is contraindicated for patients who have shown a previous hypersensitivity to any component of this medication.
⚠️ Warnings ▾
WARNINGS Nursing Mothers: It is not known whether this drug is excreted in human milk. Since many drugs are so excreted, hydroxyzine should not be given to nursing mothers.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Side effects reported with the administration of hydroxyzine hydrochloride are usually mild and transitory in nature. Skin and appendages: Oral hydroxyzine hydrochloride is associated with Acute Generalized Exanthematous Pustulosis (AGEP) and fixed drug eruptions in post marketing reports. Anticholinergic: Dry mouth.
Central Nervous System: Drowsiness is usually transitory and may disappear in a few days of continued therapy or upon reduction of the dose. Involuntary motor activity including rare instances of tremor and convulsions have been reported, usually with doses considerably higher than those recommended. Clinically significant respiratory depression has not been reported at recommended doses.
Cardiac System: QT prolongation, Torsade de Pointes. Skin and appendages: Pruritis, rash, uticaria
🆘 Overdosage ▾
OVERDOSAGE The most common manifestation of overdosage of hydroxyzine hydrochloride is hypersedation. Other reported signs and symptoms were convulsions, stupor, nausea and vomiting. As in the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken.
If vomiting has not occurred spontaneously, it should be induced. Immediate gastric lavage is also recommended. General supportive care, including frequent monitoring of the vital signs and close observation of the patient, is indicated.
Hypotension, though unlikely, may be controlled with intravenous fluids and vasopressors (do not use epinephrine as hydroxyzine counteracts its pressor action). Caffeine and Sodium Benzoate Injection, USP, may be used to counteract central nervous system depressant effects. There is no specific antidote.
It is doubtful that hemodialysis would be of any value in the treatment of overdosage with hydroxyzine. However, if other agents such as barbiturates have been ingested concomitantly, hemodialysis may be indicated. There is no practical method to quantitate hydroxyzine in body fluids or tissue after its ingestion or administration.
Hydroxyzine overdose may cause QT prolongation and Torsade de Pointes. ECG monitoring is recommended in cases of hydroxyzine overdose.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Hydroxyzine hydrochloride is unrelated chemically to the phenothiazines, reserpine, meprobamate, or the benzodiazepines. Hydroxyzine hydrochloride is not a cortical depressant, but its action may be due to suppression of activity in certain key regions of the subcortical area of the central nervous system. Primary skeletal muscle relaxation has been demonstrated experimentally.
Bronchodilator activity, and antihistaminic and analgesic effects have been demonstrated experimentally and confirmed clinically. An antiemetic effect, both by the apomorphine test and the veriloid test, has been demonstrated. Pharmacological and clinical studies indicate that hydroxyzine in therapeutic dosage does not increase gastric secretion or acidity and in most cases has mild antisecretory activity.
Hydroxyzine is rapidly absorbed from the gastrointestinal tract and its clinical effects are usually noted within 15 to 30 minutes after oral administration.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Hydroxyzine Hydrochloride Syrup (Hydroxyzine Hydrochloride Oral Solution, USP) 10 mg per 5 mL (teaspoonful) is a slightly yellow peppermint flavored liquid, supplied in 473 mL (16 fl. oz.) plastic bottles. NDC 54838-502-80 Store at controlled room temperature 15° to 30°C (59° to 86°F). [See USP controlled room temperature]. Dispense in a tight, light-resistant container with child-resistant closure as defined in the USP.
Distributed by: Lannett Company, Inc. Philadelphia, PA 19136 10-1114 Rev. 01/23
📋 Description ▾
DESCRIPTION Hydroxyzine hydrochloride is designated chemically as (±)-2-[2-[4-( p -Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. Inert ingredients: citric acid, peppermint flavor, sodium benzoate, sucrose and water. Citric acid and/or sodium citrate may be used to adjust the pH when necessary. molec-struc