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

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Active Ingredient

(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

cetiri 10mg.jpg

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:52959-923
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE10 mg
Product Characteristics
ColorwhiteScorescore with uneven pieces
ShapeROUNDSize8mm
FlavorImprint Code SZ;906
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52959-923-1010 in 1 CONTAINER; Type 0: Not a Combination Product01/03/2017
2NDC:52959-923-1515 in 1 CONTAINER; Type 0: Not a Combination Product01/03/2017
3NDC:52959-923-3030 in 1 CONTAINER; Type 0: Not a Combination Product01/03/2017
4NDC:52959-923-6060 in 1 CONTAINER; Type 0: Not a Combination Product01/03/2017
5NDC:52959-923-9090 in 1 CONTAINER; Type 0: Not a Combination Product01/03/2017
6NDC:52959-923-077 in 1 CONTAINER; Type 0: Not a Combination Product01/03/2017
7NDC:52959-923-2020 in 1 CONTAINER; Type 0: Not a Combination Product01/03/2017
8NDC:52959-923-1414 in 1 CONTAINER; Type 0: Not a Combination Product01/03/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07794601/03/2017
Labeler - H. J. Harkins Company Inc. (147681894)
Establishment
NameAddressID/FEIBusiness Operations
H. J. Harkins Company Inc.147681894manufacture(52959-923) , relabel(52959-923) , repack(52959-923)

Revised: 12/2017
Document Id: 5f4e05af-61a5-7f84-e053-2a91aa0ac6f6
Set id: 5f4e05af-61a4-7f84-e053-2a91aa0ac6f6
Version: 1
Effective Time: 20171201
 
H. J. Harkins Company Inc.