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Medicine guide

Hydroxyzine Hydrochloride

50 mg · Tablet, Film Coated

  • Prescription only
  • Antihistamine
Made by
American Health Packaging

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2025-09-15

What it is

Antihistamine

Used for
  • For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested.
The label’s usual adult dose

Adults, 50 to 100 mg q.i.d.;

Full directions ↓
Do not take it if

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.

All warnings ↓
Good to know
  • Prescription only
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
128other products contain Hydroxyzine Hydrochloride — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

  • 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 as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine 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.

From the official label · 2025-09-15 · DailyMed

How it works

From this product’s own US prescribing label.

Hydroxyzine hydrochloride is unrelated chemically to the phenothiazines, reserpine, meprobamate or the benzodiazepines.

Hydroxyzine is not a cortical depressant, but its action may be due to a suppression of activity in certain key regions of the subcortical area of the central nervous system.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-09-15

Do not take it if

  • 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.

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

  • For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested:
  • adults, 50 to 100 mg q.i.d.;
  • 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:
  • adults, 25 mg t.i.d. or q.i.d.;
  • children under 6 years, 50 mg daily in divided doses; 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 for
  • adults and 0.6 mg/kg of body weight in children.
  • When treatment is initiated by the intramuscular route of administration, subsequent doses may be administered orally.
  • As with all potent medication, the dosage should be adjusted according to the patient's response to therapy.

Quoted from the official label, section “Dosage & Administration”.

Other 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.
  • THE POTENTIATING ACTION OF HYDROXYZINE MUST BE CONSIDERED WHEN THE DRUG IS USED IN CONJUNCTION WITH CENTRAL NERVOUS SYSTEM DEPRESSANTS SUCH AS NARCOTICS, NON-NARCOTIC ANALGESICS AND BARBITURATES.
  • Therefore, when central nervous system depressants are administered concomitantly with hydroxyzine their dosage should be reduced.
  • QT Prolongation/Torsade de Pointes (TdP):
  • Cases of QT prolongation and Torsade de Pointes have been reported during post-marketing use of hydroxyzine.
  • The majority of reports occurred in patients with other risk factors for QT prolongation/TdP (pre-existing heart disease, electrolyte imbalances or concomitant arrhythmogenic drug use).
  • Therefore, hydroxyzine should be used with caution in patients with risk factors for QT prolongation, congenital long QT syndrome, a family history of long QT syndrome, other conditions that predispose to QT prolongation and ventricular arrhythmia, as well as recent myocardial infarction, uncompensated heart failure, and bradyarrhythmias.
  • Caution is recommended during the concomitant use of drugs known to prolong the QT interval.
  • These include Class 1A (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmics, certain antipsychotics (e.g., ziprasidone, iloperidone, clozapine, quetiapine, chlorpromazine), certain antidepressants (e.g., citalopram, fluoxetine), certain antibiotics (e.g., azithromycin, erythromycin, clarithromycin, gatifloxacin, moxifloxacin); and others (e.g., pentamidine, methadone, ondansetron, droperidol).
  • Since drowsiness may occur with use of this drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery while taking hydroxyzine.
  • Patients should also be advised against the simultaneous use of other CNS depressant drugs, and cautioned that the effects of alcohol may be increased.
  • Geriatric Use A determination has not been made whether controlled clinical studies of hydroxyzine included sufficient numbers of subjects aged 65 and over to define a difference in response from younger subjects.

Quoted from the official label, section “Warnings”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

  • The most common manifestation of hydroxyzine overdosage 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 levarterenol or metaraminol.
  • Do not use epinephrine as hydroxyzine counteracts its pressor action.
  • Hydroxyzine overdose may cause QT prolongation and Torsade de Pointes.
  • ECG monitoring is recommended in cases of hydroxyzine overdose.
  • 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.

Quoted from the official label, section “Overdosage”.

Use in older people

  • A determination has not been made whether controlled clinical studies of hydroxyzine included sufficient numbers of subjects aged 65 and over to define a difference in response 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.
  • The extent of renal excretion of hydroxyzine has not been determined.
  • Because elderly patients are more likely to have decreased renal function, care should be taken in dose selections.
  • Sedating drugs may cause confusion and over sedation in the elderly; elderly patients generally should be started on low doses of hydroxyzine and observed closely.
  • Acute Generalized Exanthematous Pustulosis (AGEP) Hydroxyzine may rarely cause Acute Generalized Exanthematous Pustulosis (AGEP), a serious skin reaction characterized by fever and numerous small, superficial, non-follicular, sterile pustules, arising within large areas of edematous erythema.
  • Inform patients about the signs of AGEP, and discontinue hydroxyzine at the first appearance of a skin rash, worsening of pre-existing skin reactions which hydroxyzine may be used to treat, or any other sign of hypersensitivity.
  • If signs or symptoms suggest AGEP, use of hydroxyzine should not be resumed and alternative therapy should be considered.
  • Avoid cetirizine or levocetirizine in patients who have experienced AGEP or other hypersensitivity reactions with hydroxyzine, due to the risk of cross-sensitivity.

Quoted from the official label, section “Geriatric Use”.

Side effects

  • Side effects reported with the administration of hydroxyzine hydrochloride are usually mild and transitory in nature.
  • Anticholinergic: Dry mouth.
  • Central Nervous System:
  • Drowsiness is usually transitory and may disappear in a few days of continued therapy or upon reduction of 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.
  • In postmarketing experience, the following additional undesirable effects have been reported:
  • Body as a Whole:
  • Allergic reaction.
  • Nervous System: Headache.
  • Psychiatric: Hallucination.
  • Skin and Appendages:
  • Oral hydroxyzine is associated with Acute Generalized Exanthematous Pustulosis (AGEP) and fixed drug eruptions in post marketing reports; pruritus, rash, urticaria.

Quoted from the official label, section “Adverse Reactions”.

What it looks like and how it is packed

  • Hydroxyzine Hydrochloride Tablets USP, 50 mg are purple, round, biconvex, film-coated tablets debossed with "7" on one side and plain on other side.
  • They are supplied as follows:
  • Unit dose packages of 100 (10 x 10) NDC 60687-875-01 STORAGE
  • Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
  • KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
  • FOR YOUR PROTECTION: Do not use if blister is torn or broken.
  • PACKAGING INFORMATION American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Aurobindo Pharma USA, Inc. as follows:
  • (50 mg / 100 UD) NDC 60687-875-01 packaged from NDC 59651-501 Distributed by:
  • American Health Packaging Columbus, OH 43217 8487501/1124

Quoted from the official label, section “How Supplied”.

What is in it

  • Hydroxyzine hydrochloride has the chemical name of 2-[2-[4-( p -Chloro-α-phenylbenzyl)-1-piperazinyl] ethoxy] ethanol dihydrochloride. C 21 H 27 ClN 2 O 2
  • 2HCl Molecular Weight 447.83 Hydroxyzine hydrochloride USP occurs as a white powder which is very soluble in water. Each tablet for oral administration contains 10 mg, 25 mg or 50 mg hydroxyzine hydrochloride USP. Inactive ingredients include FD&C blue #2 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch (corn), and titanium dioxide. In addition, 10 mg contains D&C red #30 aluminum lake, 25 mg and 50 mg contains D&C red #7 calcium lake. CHEMICAL STRUCTURE

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

  • Lactoselactose monohydrateMilk sugar: matters with lactose intolerance or a milk allergy.
  • Colour dyesFD&C blue #2 aluminum lakeSome people react to dyes such as tartrazine (Yellow 5) or carmine.
  • Titanium dioxidetitanium dioxideA whitening agent no longer allowed in food in the EU (E171).

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (39)

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Every strength and form (9)

Details

Made byAmerican Health Packaging
Active substanceHydroxyzine Hydrochloride
Used inBreathing, airways, allergies and cough
Strength50 mg
FormTablet, Film Coated
RouteOral
Packs100 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED in 1 BLISTER PACK
NDC60687-875

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

133 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Show all forms · 5 forms

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Hydroxyzine Hydrochloride10 mgPrescription onlyTablet, Film Coated Teva Pharmaceuticals USA, Inc. · Hydroxyzine HydrochlorideHydroxyzine Hydrochloride25 mgPrescription onlyTablet, Film Coated Teva Pharmaceuticals USA, Inc. · Hydroxyzine HydrochlorideHydroxyzine Hydrochloride50 mgPrescription onlyTablet, Film Coated Teva Pharmaceuticals USA, Inc. · Hydroxyzine HydrochlorideHydroxyzine Hydrochloride10 mg/5mLPrescription onlySolution PAI Holdings, LLC dba PAI Pharma · Hydroxyzine HydrochlorideHydroxyzine Hydrochloride50 mg/mLPrescription onlyInjection, Solution Henry Schein, Inc. · Hydroxyzine HydrochlorideHydroxyzine Hydrochloride25 mg/mLPrescription onlyInjection, Solution American Regent, Inc. · Hydroxyzine Hydrochloride

See every product with Hydroxyzine Hydrochloride