INDOOR OUTDOOR ALLERGIES- cetirizine hcl tablet 
PLD Acquisitions LLC DBA Avéma Pharma Solutions

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Cetirizine Hydrochloride Tablets

Active Ingredient (in each tablet)

Cetirizine HCl 10 mg

Purpose

Antihistamine

Uses


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, sedative, 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 pregnant: ask a health professional before use
  • If breast-feeding: not recommended

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

 adults and children 6 years and over Take one 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 over  ask a doctor.
 Children under 6 years of age  ask a doctor
 Consumers with liver or kidney disease  ask a doctor

Other Information

Inactive Ingredients

corn starch, hypromellose, lactose monohydrate, macrogol, magnesium stearate,  povidone, titanium dioxide.

Questions or comments?


Principal Display Panel

*Compare to the active ingredient in Zyrtec®

Cetirizine HCL Tablets, USP 10 mg

Antihistamine

Indoor & Outdoor allergies

24 hour relief of

Tablets

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Zyrtec®

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.


Product Label

Cetirizine HCL 10 mg

Cetirizine HCL Tablets

INDOOR OUTDOOR ALLERGIES 
cetirizine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63548-0739
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
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize10mm
FlavorImprint Code 432
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63548-0739-31 in 1 BOX07/01/2019
1300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07794607/01/2019
Labeler - PLD Acquisitions LLC DBA Avéma Pharma Solutions (804087794)

Revised: 2/2023
Document Id: a06103f0-b1c2-42e5-9089-7d1cd3f694e3
Set id: 82127ab5-cf5c-4739-b7e5-8912f855618a
Version: 2
Effective Time: 20230209
 
PLD Acquisitions LLC DBA Avéma Pharma Solutions