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

company logo

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.

label 10 mg -- 100s
(click image for full-size original)

Packaging Size: 500s


NDC 10702-010-50

HydrOXYzine HCL

Tablets, USP

10 mg

500 TABLETS

Rx Only

KVK-TECH, INC.

label 10 mg -- 500s
(click image for full-size original)

Packaging Size: 1000s

NDC 10702-010-10

HydrOXYzine HCL

Tablets, USP

10 mg

1000 TABLETS

Rx Only

KVK-TECH, INC.

label 10 mg -- 1000s
(click image for full-size original)

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.

label 25 mg -- 100s
(click image for full-size original)

Packaging Size: 500s


NDC 10702-011-50

HydrOXYzine HCL

Tablets, USP

25 mg

Rx Only 500 TABLETS

KVK-TECH, INC.

label 25 mg -- 500s
(click image for full-size original)

Packaging Size: 1000s


NDC 10702-011-01

HydrOXYzine HCL

Tablets, USP

25 mg

1000 TABLETS

Rx Only

KVK-TECH, INC.

label 25 mg -- 1000s
(click image for full-size original)

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.

Label 50 mg -- 100s
(click image for full-size original)

Packaging Size: 500s


NDC 10702-012-50

HydrOXYzine HCL

Tablets, USP

50 mg

500 TABLETS

Rx Only

KVK-TECH, INC.

Label 50 mg -- 500s
(click image for full-size original)

Packaging Size: 1000s


NDC 10702-012-10

HydrOXYzine HCL

Tablets, USP

50 mg

1000 TABLETS

Rx Only

KVK-TECH, INC.

Label 50 mg -- 1000s
(click image for full-size original)

HYDROXYZINE HYDROCHLORIDE
hydroxyzine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10702-010
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROXYZINE DIHYDROCHLORIDE (HYDROXYZINE) HYDROXYZINE DIHYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE
HYPROMELLOSE 2910 (6 MPA.S)
HYPROMELLOSE 2208 (3 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape ROUND Size 7mm
Flavor Imprint Code K;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10702-010-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:10702-010-50 500 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:10702-010-10 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040786 07/24/2012
HYDROXYZINE HYDROCHLORIDE
hydroxyzine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10702-011
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROXYZINE DIHYDROCHLORIDE (HYDROXYZINE) HYDROXYZINE DIHYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE
HYPROMELLOSE 2910 (6 MPA.S)
HYPROMELLOSE 2208 (3 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape ROUND Size 8mm
Flavor Imprint Code K;11
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10702-011-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:10702-011-50 500 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:10702-011-10 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040786 07/24/2012
HYDROXYZINE HYDROCHLORIDE
hydroxyzine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10702-012
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROXYZINE DIHYDROCHLORIDE (HYDROXYZINE) HYDROXYZINE DIHYDROCHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE
HYPROMELLOSE 2910 (6 MPA.S)
HYPROMELLOSE 2208 (3 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape ROUND Size 9mm
Flavor Imprint Code K;12
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10702-012-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:10702-012-50 500 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:10702-012-10 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040786 07/24/2012
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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