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Cetirizine by NCS HealthCare of KY, Inc dba Vangard Labs

Medically reviewed on Sep 12, 2018

Dosage form: tablet
Ingredients: CETIRIZINE HYDROCHLORIDE 10mg
Labeler: NCS HealthCare of KY, Inc dba Vangard Labs
NDC Code: 0615-7522

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

 

CETIRIZINE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0615-7522(NDC:0781-1684)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
HYPROMELLOSES 
LACTOSE MONOHYDRATE 
POLYETHYLENE GLYCOLS 
MAGNESIUM STEARATE 
POVIDONES 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITE (white to off-white) Scoreno score
ShapeROUND (round shape) Size8mm
FlavorImprint CodeSZ;906
Contains    
Packaging
#Item CodePackage Description
1NDC:0615-7522-3930 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07794612/27/2007
Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)
Establishment
NameAddressID/FEIOperations
NCS HealthCare of KY, Inc dba Vangard Labs050052943REPACK(0615-7522)

 
NCS HealthCare of KY, Inc dba Vangard Labs

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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