CETIRIZINE HYDROCHLORIDE

CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet
H. J. Harkins Company Inc.

(in each tablet)

Cetirizine HCl 10 mg

Purpose

Antihistamine

Keep out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away.

USES

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:


runny nose

sneezing

itchy, watery eyes

itching of the nose or throat

Warnings

antihistamine containing hydroxyzine.

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

When using this product


drowsiness may occur

avoid alcoholic drinks

alcohol, sedatives, and tranquilizers may increase drowsiness

be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding:


if breast-feeding: not recommended
• if pregnant: ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

dults and children 6 years and over

One 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.

adults 65 years and over

ask a doctor

children under 6 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

Inactive Ingredient

Corn starch, hypromellose, lactose monohydrate, macrogol, magnesium stearate, povidone and titanium dioxide.

Questions? 1-800-525-8747

Manufactured in India by Sandoz Private Ltd.,

for Sandoz Inc., Princeton, NJ 08540

Rev.06/2013

Package Label. Principal Display Panel

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CETIRIZINE HYDROCHLORIDE cetirizine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52959-923
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE 10 mg
Product Characteristics
Color white Score score with uneven pieces
Shape ROUND Size 8mm
Flavor Imprint Code SZ;906
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52959-923-10 10 TABLET in 1 CONTAINER None
2 NDC:52959-923-15 15 TABLET in 1 CONTAINER None
3 NDC:52959-923-30 30 TABLET in 1 CONTAINER None
4 NDC:52959-923-60 60 TABLET in 1 CONTAINER None
5 NDC:52959-923-90 90 TABLET in 1 CONTAINER None
6 NDC:52959-923-07 7 TABLET in 1 CONTAINER None
7 NDC:52959-923-20 20 TABLET in 1 CONTAINER None
8 NDC:52959-923-14 14 TABLET in 1 CONTAINER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077946 01/03/2017
Labeler — H. J. Harkins Company Inc. (147681894)
Establishment
Name Address ID/FEI Operations
H. J. Harkins Company Inc. 147681894 manufacture (52959-923), relabel (52959-923), repack (52959-923)

Revised: 12/2017 H. J. Harkins Company Inc.

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