CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet 
Ohm Laboratories Inc.

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Cetirizine Hydrochloride

Drug Facts

Active ingredient (in each tablet)

Cetirizine HCl, USP 10 mg

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 (1-800-222-1222).

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

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

Questions?

call 1-800-406-7984

Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label

NDC 51660-939-53

Compare To
the active ingredient of
Zyrtec®

ohm®
Allergy Relief
Cetirizine HCl Tablets, USP 10 mg
ANTIHISTAMINE
Indoor & Outdoor Allergies

24 Hour Relief of:
• Sneezing • Runny Nose
• Itchy, Watery Eyes • Itchy Throat or Nose

300 TABLETS
10 mg EACH

24
Hours

Original Prescription Strength

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51660-939
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
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColorwhiteScoreno score
ShapeRECTANGLE (rounded-off) Size9mm
FlavorImprint Code RI52
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51660-939-5414 in 1 BLISTER PACK; Type 0: Not a Combination Product12/27/2007
2NDC:51660-939-3030 in 1 BOTTLE; Type 0: Not a Combination Product12/27/2007
3NDC:51660-939-9090 in 1 BOTTLE; Type 0: Not a Combination Product12/27/2007
4NDC:51660-939-13120 in 1 BOTTLE; Type 0: Not a Combination Product12/27/2007
5NDC:51660-939-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/27/2007
6NDC:51660-939-53300 in 1 BOTTLE; Type 0: Not a Combination Product12/27/2007
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07749812/27/2007
Labeler - Ohm Laboratories Inc. (184769029)
Registrant - Sun Pharmaceutical Industries Inc. (146974886)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.184769029MANUFACTURE(51660-939)

Revised: 5/2021
Document Id: 2a87ee90-da59-4e35-9cda-27759ba080d4
Set id: 161c4122-2c89-46e6-a6ae-db088087330d
Version: 8
Effective Time: 20210521
 
Ohm Laboratories Inc.