ALLERGY RELIEF- cetirizine hcl 10 mg tablet 
Genomma Labs USA, Inc

----------

Drug Facts

Active ingredient

Cetirizine HCl 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 doctor if you have

  • liver or kidney disease. Your doctor should determine if you need a different dose.

Ask doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when drivinga motor vehicle or operating machinery

Stop use and ask doctor

if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast feeding

If pregnant or breast-feeding, ask a health professional before use.

Keep Out of Reach of Children

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

Directions

Other information

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Questions or Comments

Call toll free 1-877-994-3666
Monday to Friday, 8 am to 6 pm

Package/Label Principal Display Panel

Cetirizine 10mg Front

Cetirizine 10mg Front

Cetirizine 10mg Back

Cetirizine 10mg back

ALLERGY RELIEF 
cetirizine hcl 10 mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-396
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
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeRECTANGLE (pillow-shaped) Size9mm
FlavorImprint Code G;4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50066-396-8290 in 1 BOTTLE; Type 0: Not a Combination Product11/06/2020
2NDC:50066-396-3030 in 1 BOTTLE; Type 0: Not a Combination Product11/06/2020
3NDC:50066-396-453 in 1 CARTON09/20/201910/26/2022
315 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:50066-396-091 in 1 CARTON09/20/201910/26/2022
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20927412/22/2017
Labeler - Genomma Labs USA, Inc (832323534)

Revised: 9/2019
Document Id: d5a01d33-2431-447c-83d2-081ee63663a1
Set id: 9f266258-7a76-49eb-810c-93389023d57e
Version: 7
Effective Time: 20190920
 
Genomma Labs USA, Inc