CETIRIZINE- cetirizine hydrochloride tablet

Cetirizine by

Drug Labeling and Warnings

Cetirizine by is a Otc medication manufactured, distributed, or labeled by NCS HealthCare of KY, Inc dba Vangard Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

 

INGREDIENTS AND APPEARANCE

CETIRIZINE 
cetirizine hydrochloride tablet

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

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

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONES (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

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

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

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

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