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

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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

  • 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.

Carton

10 mg carton Labeling

Carton

Bottle Label

Container

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablets tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43598-811
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:43598-811-301 in 1 CARTON12/17/2018
1300 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:43598-811-051 in 1 CARTON12/17/2018
2500 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:43598-811-901 in 1 CARTON12/17/2018
390 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:43598-811-12100 in 1 BOTTLE; Type 0: Not a Combination Product09/03/2019
5NDC:43598-811-15500 in 1 BOTTLE; Type 0: Not a Combination Product09/03/2019
6NDC:43598-811-13300 in 1 BOTTLE; Type 0: Not a Combination Product09/03/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07834312/17/2018
Labeler - Dr. Reddy's Laboratories Inc. (802315887)

Revised: 12/2022
Document Id: 6e5c090a-d8fd-717c-26a0-acfb071ba7f4
Set id: e4eca4df-9ad8-b7c4-b512-bfaed5673789
Version: 5
Effective Time: 20221222
 
Dr. Reddy's Laboratories Inc.