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

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Cetirizine Hydrochloride Tablets

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

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
  • 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

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.

PRINCIPAL DISPLAY PANEL

Bottle label

Bottle

PRINCIPAL DISPLAY PANEL

Carton label

Carton

    

    

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55111-699
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize7mm
FlavorImprint Code C
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55111-699-901 in 1 CARTON04/08/2008
190 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:55111-699-451 in 1 CARTON04/08/2008
245 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:55111-699-301 in 1 CARTON04/03/2008
330 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:55111-699-511 in 1 CARTON07/22/2008
475 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:55111-699-041 in 1 CARTON04/11/2008
5120 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:55111-699-191 in 1 CARTON01/15/2008
6175 in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:55111-699-472 in 1 CARTON04/03/2008
7175 in 1 BOTTLE; Type 0: Not a Combination Product
8NDC:55111-699-601 in 1 CARTON04/07/2008
860 in 1 BOTTLE; Type 0: Not a Combination Product
9NDC:55111-699-731 in 1 CARTON10/06/2010
9365 in 1 BOTTLE; Type 0: Not a Combination Product
10NDC:55111-699-521 in 1 CARTON10/06/2010
1014 in 1 BOTTLE; Type 0: Not a Combination Product
11NDC:55111-699-742 in 1 CARTON04/04/2008
117 in 1 BLISTER PACK; Type 0: Not a Combination Product
12NDC:55111-699-311 in 1 CARTON09/27/2016
12300 in 1 BOTTLE; Type 0: Not a Combination Product
13NDC:55111-699-151 in 1 CARTON04/04/2008
1314 in 1 BLISTER PACK; Type 0: Not a Combination Product
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 DRUGItem Code (Source)NDC:55111-351
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize6mm
FlavorImprint Code RDY;351
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55111-351-301 in 1 CARTON01/15/2008
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:55111-351-451 in 1 CARTON01/15/2008
245 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:55111-351-601 in 1 CARTON01/15/2008
360 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:55111-351-901 in 1 CARTON01/15/2008
490 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:55111-351-041 in 1 CARTON01/15/2008
5120 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:55111-351-472 in 1 CARTON01/15/2008
6175 in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:55111-351-511 in 1 CARTON01/15/2008
775 in 1 BOTTLE; Type 0: Not a Combination Product
8NDC:55111-351-742 in 1 CARTON01/15/2008
87 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07834301/15/2008
Labeler - Dr.Reddy's Laboratories Limited (650562841)

Revised: 9/2011
Document Id: 36bfe6fc-ad7e-a44a-b24c-7b2bdc8d2067
Set id: de152651-bfcd-856a-8329-a2ac93a376bc
Version: 7
Effective Time: 20110930
 
Dr.Reddy's Laboratories Limited