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

(in each tablet)

Cetirizine HCl 10 mg



Keep out of Reach of Children

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


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

runny nose


itchy, watery eyes

itching of the nose or throat


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.


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


Package Label. Principal Display Panel

(click image for full-size original)

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
Product Characteristics
Color white Score score with uneven pieces
Shape ROUND Size 8mm
Flavor Imprint Code SZ;906
# 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)
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.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.