Hydroxyzine Hydrochloride (Page 2 of 2)
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 administered orally.
As with all potent medication, the dosage should be adjusted according to the patient’s response to therapy.
HOW SUPPLIED
Hydroxyzine Hydrochloride Tablets, USP are available as follows:
Hydroxyzine hydrochloride tablets, USP 10 mg are supplied as white, round, film coated, biconvex tablets debossed “K10” on one side and plain on the other side.
Bottle of 100, NDC 10702-010-01
Bottle of 500, NDC 10702-010-50
Bottle of 1000, NDC 10702-010-10
Hydroxyzine hydrochloride tablets, USP 25 mg are supplied as white, round, film coated, biconvex tablets debossed “K11” on one side and plain on the other side.
Bottle of 100, NDC 10702-011-01
Bottle of 500, NDC 10702-011-50
Bottle of 1000, NDC 10702-011-10
Hydroxyzine hydrochloride tablets, USP 50 mg are supplied as white, round, film coated, biconvex tablets debossed “K12” on one side and plain on the other side.
Bottle of 100, NDC 10702-012-01
Bottle of 500, NDC 10702-012-50
Bottle of 1000, NDC 10702-012-10
Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).
Store at 20° to 25°C with excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Manufactured by:
KVK-TECH, INC.
110 Terry Drive
Newtown, PA 18940
Item ID # 6015/12 11/2018
Manufacturer’s Code: 10702
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL – 10 mg Bottle Label
Packaging Size: 100s
NDC 10702-010-01
HydrOXYzine HCL
Tablets, USP
10 mg
100 TABLETS
Rx Only
KVK-TECH, INC.
Packaging Size: 500s
NDC 10702-010-50
HydrOXYzine HCL
Tablets, USP
10 mg
500 TABLETS
Rx Only
KVK-TECH, INC.
Packaging Size: 1000s
NDC 10702-010-10
HydrOXYzine HCL
Tablets, USP
10 mg
1000 TABLETS
Rx Only
KVK-TECH, INC.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL – 25 mg Bottle Label
Packaging Size: 100s
NDC 10702-011-01
HydrOXYzine HCL
Tablets, USP
25 mg
100 TABLETS
Rx Only
KVK-TECH, INC.
Packaging Size: 500s
NDC 10702-011-50
HydrOXYzine HCL
Tablets, USP
25 mg
Rx Only 500 TABLETS
KVK-TECH, INC.
Packaging Size: 1000s
NDC 10702-011-01
HydrOXYzine HCL
Tablets, USP
25 mg
1000 TABLETS
Rx Only
KVK-TECH, INC.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL – 50 mg Bottle Label
Packaging Size: 100s
NDC 10702-012-01
HydrOXYzine HCL
Tablets, USP
50 mg
100 TABLETS
Rx Only
KVK-TECH, INC.
Packaging Size: 500s
NDC 10702-012-50
HydrOXYzine HCL
Tablets, USP
50 mg
500 TABLETS
Rx Only
KVK-TECH, INC.
Packaging Size: 1000s
NDC 10702-012-10
HydrOXYzine HCL
Tablets, USP
50 mg
1000 TABLETS
Rx Only
KVK-TECH, INC.
HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride tablet, film coated | ||||||||||||||||||||||
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HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride tablet, film coated | ||||||||||||||||||||||
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HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride tablet, film coated | ||||||||||||||||||||||
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Labeler — KVK-Tech, Inc. (173360061) |
Registrant — KVK-Tech, Inc. (173360061) |
Establishment | |||
Name | Address | ID/FEI | Operations |
KVK-Tech, Inc. | 173360061 | manufacture (10702-010), manufacture (10702-011), manufacture (10702-012) |
Revised: 01/2023 KVK-Tech, Inc.
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