CETIRIZINE HYDROCHLORIDE - cetirizine hydrochloride tablet, film coated 
Dr.Reddy's Laboratories Limited

----------

Cetirizine Hydrochloride Tablets

Drug Facts

Active ingredient (in each tablet)

Cetirizine HCl 10mg

Purpose

Antihistamine

Uses

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

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

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding:

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

Directions

For 5 mg:

adults and children 6 years and over1 to 2 tablets once daily depending updon severity of symptoms do not take more than 2 tablets in 24 hours.
adults 65 years and over1 tablet once a day; do not take more than 1 tablet in 24 hours
children under 6 years of ageask a doctor.
consumers with liver or kidney diseaseask a doctor

For 10 mg:

adults and children 6 years and overone 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 overask a doctor.
children under 6 years of ageask a doctor.
consumers with liver or kidney diseaseask a doctor

Other information

Inactive ingredients

hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, starch, titanium dioxide.

Questions?

call 1-888-375-3784.

Manufactured by:

Dr. Reddy’s Laboratories Limited

Bachepalli - 502 325 INDIA

PRINCIPAL DISPLAY PANEL - Container Cartons

5 mg Container Carton - Allergy:

5containercarton.jpg

10 mg Container Carton - Allergy:

10containercarton.jpg

PRINCIPAL DISPLAY PANEL - Containers

5 mg Containers:

5container.jpg

5container1.jpg

10 mg Containers:

10container.jpg

10container1.jpg

    

    


CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride   tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)55111-350
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOL 
POVIDONE 
STARCH, CORN 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScore no score
ShapeROUNDSize6mm
FlavorImprint Code RDY;350
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
155111-350-301 BOTTLE In 1 CARTONcontains a BOTTLE
130 TABLET In 1 BOTTLEThis package is contained within the CARTON (55111-350-30)
255111-350-451 BOTTLE In 1 CARTONcontains a BOTTLE
245 TABLET In 1 BOTTLEThis package is contained within the CARTON (55111-350-45)
355111-350-751 BOTTLE In 1 CARTONcontains a BOTTLE
375 TABLET In 1 BOTTLEThis package is contained within the CARTON (55111-350-75)
455111-350-901 BOTTLE In 1 CARTONcontains a BOTTLE
490 TABLET In 1 BOTTLEThis package is contained within the CARTON (55111-350-90)
555111-350-041 BOTTLE In 1 CARTONcontains a BOTTLE
5120 TABLET In 1 BOTTLEThis package is contained within the CARTON (55111-350-04)
655111-350-071 BLISTER PACK In 1 CARTONcontains a BLISTER PACK
65 TABLET In 1 BLISTER PACKThis package is contained within the CARTON (55111-350-07)
755111-350-742 BLISTER PACK In 1 CARTONcontains a BLISTER PACK
77 TABLET In 1 BLISTER PACKThis package is contained within the CARTON (55111-350-74)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07834301/15/2008

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride   tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)55111-351
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOL 
POVIDONE 
STARCH, CORN 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScore no score
ShapeROUNDSize7mm
FlavorImprint Code RDY;351
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
155111-351-301 BOTTLE In 1 CARTONcontains a BOTTLE
130 TABLET In 1 BOTTLEThis package is contained within the CARTON (55111-351-30)
255111-351-401 BOTTLE In 1 CARTONcontains a BOTTLE
240 TABLET In 1 BOTTLEThis package is contained within the CARTON (55111-351-40)
355111-351-451 BOTTLE In 1 CARTONcontains a BOTTLE
345 TABLET In 1 BOTTLEThis package is contained within the CARTON (55111-351-45)
455111-351-601 BOTTLE In 1 CARTONcontains a BOTTLE
460 TABLET In 1 BOTTLEThis package is contained within the CARTON (55111-351-60)
555111-351-751 BOTTLE In 1 CARTONcontains a BOTTLE
575 TABLET In 1 BOTTLEThis package is contained within the CARTON (55111-351-75)
655111-351-901 BOTTLE In 1 CARTONcontains a BOTTLE
690 TABLET In 1 BOTTLEThis package is contained within the CARTON (55111-351-90)
755111-351-041 BOTTLE In 1 CARTONcontains a BOTTLE
7120 TABLET In 1 BOTTLEThis package is contained within the CARTON (55111-351-04)
855111-351-642 BOTTLE In 1 CARTONcontains a BOTTLE
8120 TABLET In 1 BOTTLEThis package is contained within the CARTON (55111-351-64)
955111-351-191 BOTTLE In 1 CARTONcontains a BOTTLE
9175 TABLET In 1 BOTTLEThis package is contained within the CARTON (55111-351-19)
1055111-351-071 BLISTER PACK In 1 CARTONcontains a BLISTER PACK
105 TABLET In 1 BLISTER PACKThis package is contained within the CARTON (55111-351-07)
1155111-351-742 BLISTER PACK In 1 CARTONcontains a BLISTER PACK
117 TABLET In 1 BLISTER PACKThis package is contained within the CARTON (55111-351-74)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07834301/15/2008

Labeler - Dr.Reddy's Laboratories Limited (862179079)
Revised: 09/2009Dr.Reddy's Laboratories Limited