United States - English - NLM (National Library of Medicine)
HYDROXYZINE HYDROCHLORIDE- hydroxyzine hydrochloride tablet, film coated
Hydroxyzine Hydrochloride Tablets USP, Film-Coated
Hydroxyzine hydrochloride, USP has the chemical name of 2-[2-[4-( p-Chloro-α-phenylbenzyl)-1-
Hydroxyzine hydrochloride, USP occurs as a white, odorless 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 carnauba wax, colloidal silicon dioxide, crospovidone, lactose
monohydrate, magnesium stearate, microcrystalline cellulose, D&C Yellow #10 Aluminum Lake (25 mg
and 50 mg), FD&C Blue #2 Aluminum Lake (25 mg), FD&C Red #40 Aluminum Lake (50 mg), FD&C
Yellow #6 Aluminum Lake (10 mg and 50 mg), hypromellose, polyethylene glycol 3350, polyvinyl
alcohol, talc, titanium dioxide, triacetin and yellow iron oxide (10 mg).
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.
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 hydroxyzine’s clinical effects are
usually noted within 15 to 30 minutes after oral administration.
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 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.
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.
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,
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.
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.
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
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.
Skin and Appendages: Oral hydroxyzine hydrochloride is associated with Acute Generalized
Exanthematous Pustulosis (AGEP) and fixed drug eruptions in postmarketing reports.
Pruritus, rash, urticaria.
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
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: 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
As with all potent medication, the dosage should be adjusted according to the patient's response to
Hydroxyzine Hydrochloride Tablets USP, 25 mg are available as 10/32", Green round biconvex film-
coated tablets debossed “Є” above “160” on one side and plain on the other side,
Carton of 100 tablets (10 tablets each blister pack x 10) NDC 0904-6617-61
Carton of 100 tablets (10 tablets each blister pack x 10) NDC 0904-6618-61
Hydroxyzine Hydrochloride Tablets USP, 50 mg are available as 11/32", Yellow round biconvex film-
coated tablets, debossed “Є” above “161” on one side and plain on the other side, packaged in bottles
of 100’s, 500’s and 1000’s.
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure, as
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Epic Pharma, LLC
Laurelton, NY 11413
Manufactured in USA
17177 N Laurel Park Dr., Suite 233
Livonia, MI 48152
Refer to package label for Distributor's NDC Number
Revised October 2016
PRINCIPAL DISPLAY PANEL
DRUG: Hydroxyzine Hydrochloride
GENERIC: Hydroxyzine Hydrochloride
DOSAGE: TABLET, FILM COATED
SCORE: No score
SIZE: 9 mm
PACKAGING: 90 in 1 BOTTLE, PLASTIC
HYDROXYZINE HYDROCHLORIDE 50mg in 1
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
FD&C RED NO. 40
POLYETHYLENE GLYCOL, UNSPECIFIED
CROSPOVIDONE (15 MPA.S AT 5%)
POLYVINYL ALCOHOL, UNSPECIFIED
hydroxyzine hydrochloride tablet, film coated
Product T ype
HUMAN PRESCRIPTION DRUG
Ite m Code (Source )
NDC:70 518 -2240 (NDC:0 9 0 4-6 6 18 )
Route of Administration
Active Ingredient/Active Moiety
Basis of Strength
Stre ng th
HYDRO XYZINE HYDRO CHLO RIDE (UNII: 76 755771U3) (HYDROXYZINE -
UNII:30 S50 YM8 OG)
Stre ng th
LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)
MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)
CRO SPO VIDO NE ( 15 MPA.S AT 5%) (UNII: 6 8 40 19 6 0 MK)
SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)
MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )
CARNAUBA WAX (UNII: R12CBM0 EIZ)
PO LYVINYL ALCO HO L, UNSPECIFIED (UNII: 532B59 J9 9 0 )
PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)
TALC (UNII: 7SEV7J4R1U)
D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)
TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)
FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )
FD&C RED NO . 4 0 (UNII: WZB9 127XOA)
HYPRO MELLO SE, UNSPECIFIED (UNII: 3NXW29 V3WO)
TRIACETIN (UNII: XHX3C3X6 73)
ye llo w
no sco re
S hap e
ROUND (bico nvex)
S iz e
NDC:70 518 -2240 -
9 0 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n
Pro duc t
0 7/31/20 19
Marke ting Cate gory
Application Numbe r or Monograph Citation
Marke ting Start Date
Marke ting End Date
ANDA0 40 6 0 4
0 7/31/20 19
REMEDYREPACK INC. (829572556)