CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet, chewable 
OHM LABORATORIES INC.

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Cetirizine Hydrochloride

Drug Facts

Active ingredient (in each chewable tablet)

Cetirizine hydrochloride, 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 overChew and swallow 1 tablet (10 mg) once daily; do not take more than 1 tablet (10 mg) 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

acesulfame potassium, colloidal silicon dioxide, compressible sugar, crospovidone, FD & C Blue No # 2 Aluminum Lake, FD & C Red No # 40 Aluminum Lake, guar gum, magnesium oxide light powder, magnesium stearate, mannitol, microcrystalline cellulose, pregelatinized starch, prosweet N & A flavor powder, talc, tutti frutti flavor

Questions?

Call toll free 1-800-818-4555 weekdays

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

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Carton

Compare To
the active ingredient of
Children's Zyrtec®

NDC 51660-066-30

ohm®

Original Prescription Strength

Cetirizine
Hydrochloride
Chewable
Tablets 10 mg

Antihistamine

Allergy

Tutti-frutti Flavor
No Water Needed

Indoor + Outdoor Allergies

Actual Size

24 Hour Relief of:

30 CHEWABLE
TABLETS

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Carton
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51660-066
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
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SUCROSE (UNII: C151H8M554)  
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GUAR GUM (UNII: E89I1637KE)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorPURPLEScoreno score
ShapeROUNDSize10mm
FlavorTUTTI FRUTTIImprint Code 344
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51660-066-301 in 1 CARTON07/21/2022
130 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09014207/21/2022
Labeler - OHM LABORATORIES INC. (184769029)
Establishment
NameAddressID/FEIBusiness Operations
Sun Pharmaceutical Industries Limited725959238MANUFACTURE(51660-066)

Revised: 7/2022
Document Id: 1ae46a4b-8176-44fc-bc57-ed9e62c02746
Set id: 97802669-b4bd-4807-b3c1-6c6f5a2b0c67
Version: 1
Effective Time: 20220726
 
OHM LABORATORIES INC.