CETIRIZINE- cetirizine hydrochloride tablet
NCS HealthCare of KY, LLC dba Vangard Labs

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Cetirizine HCI Tablets

Active ingredient (in each tablet)

Cetirizine HCI 10mg

Purpose

Antihistamine

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

Do not use

if you have ever had an allergic reaction to this product or any of its ingredients or to an 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

• alcohol, sedatives, and tranquilizers may increase drowsiness

• avoid alcoholic drinks

• 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 pregnant: ask a health professional before use

• If breast-feeding: not recommended

Keep out of reach of children

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

Directions

Adults 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

Other information

• store between 20º to 25ºC (68º to 77ºF)

Manufactured in India by

Sandoz Private Ltd. for

Sandoz, Inc.

Princeton, NJ 08540

Rev. 06-2013

Inactive ingredients

corn starch, hypromellose, lactose monohydrate, macrogol, magensium stearate, povidone and titanium dioxide

Questions?

1-800-525-8747

Principal Display Panel

Principal Display Panel-Cetrizine HCI Tablets, USP 10mg

CETIRIZINE
cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0615-7522(NDC:0781-1684)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	10 mg

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE (UNII: FZ989GH94E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white (white to off-white)	Score	no score
Shape	ROUND (round shape)	Size	8mm
Flavor		Imprint Code	SZ;906
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0615-7522-39	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	01/07/2010	12/31/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077946	12/27/2007	12/31/2017

Labeler - NCS HealthCare of KY, LLC dba Vangard Labs (050052943)

Name	Address	ID/FEI	Business Operations
Establishment
NCS HealthCare of KY, LLC dba Vangard Labs		050052943	repack(0615-7522)

Revised: 4/2021

Document Id: 55d31a2d-ce1a-48cc-b389-aa2f02cf222d

Set id: 36291981-a3ab-4f96-b2a1-0c2bdea90ba9

Version: 10

Effective Time: 20210409

NCS HealthCare of KY, LLC dba Vangard Labs