ZYRTEC ALLERGY- cetirizine hydrochloride tablet, film coated 
Kenvue Brands LLC

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Zyrtec ® Allergy

Drug Facts

Active ingredient (in each tablet)

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 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

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

Questions?

call 1-800-343-7805 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

Original Prescription Strength

New Look Same Relief

NDC 50580-726-71

ZYRTEC ®
ALLERGY

Cetirizine HCl tablets
10 mg /antihistamine

Indoor & Outdoor Allergies

Strength 10mg Tablets

24 hour

Relief of

30 Tablets
10 mg each

Actual Size

zyrtec-1

ZYRTEC ALLERGY 
cetirizine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-726
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeRECTANGLE (rounded-off rectangular biconvex tablet) Size9mm
FlavorImprint Code ZYRTEC;10;MG
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-726-0350 in 1 CARTON01/01/2008
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:50580-726-133 in 1 CARTON03/21/200901/31/2021
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:50580-726-305 in 1 PACKAGE01/01/200811/30/2022
31 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:50580-726-3214 in 1 PACKAGE01/01/200811/30/2022
41 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:50580-726-361 in 1 PACKAGE01/01/2008
530 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
6NDC:50580-726-501 in 1 PACKAGE01/26/2010
650 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
7NDC:50580-726-512 in 1 PACKAGE01/26/201011/30/2022
750 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
8NDC:50580-726-381 in 1 PACKAGE01/01/200812/31/2022
845 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
9NDC:50580-726-701 in 1 PACKAGE01/01/2008
970 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
10NDC:50580-726-902 in 1 PACKAGE01/26/2010
1045 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
11NDC:50580-726-6675 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product01/01/2008
12NDC:50580-726-401 in 1 PACKAGE01/20/2014
1240 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
13NDC:50580-726-912500 in 1 CARTON07/27/2018
131 in 1 POUCH; Type 0: Not a Combination Product
14NDC:50580-726-9250 in 1 TRAY07/12/2018
141 in 1 POUCH; Type 0: Not a Combination Product
15NDC:50580-726-933 in 1 CARTON07/27/2018
151 in 1 POUCH; Type 0: Not a Combination Product
16NDC:50580-726-941 in 1 PACKAGE06/15/2020
1660 in 1 BOTTLE; Type 0: Not a Combination Product
17NDC:50580-726-951 in 1 PACKAGE06/15/2020
1790 in 1 BOTTLE; Type 0: Not a Combination Product
18NDC:50580-726-965 in 1 CARTON05/30/2020
181 in 1 POUCH; Type 0: Not a Combination Product
19NDC:50580-726-9714 in 1 CARTON05/30/2020
191 in 1 POUCH; Type 0: Not a Combination Product
20NDC:50580-726-0550 in 1 CARTON03/01/2023
201 in 1 POUCH; Type 0: Not a Combination Product
21NDC:50580-726-252500 in 1 CASE03/01/2023
211 in 1 POUCH; Type 0: Not a Combination Product
22NDC:50580-726-711 in 1 CARTON11/01/2024
2230 in 1 BOTTLE; Type 0: Not a Combination Product
23NDC:50580-726-721 in 1 CARTON11/01/2024
2340 in 1 BOTTLE; Type 0: Not a Combination Product
24NDC:50580-726-731 in 1 CARTON11/01/2024
2460 in 1 BOTTLE; Type 0: Not a Combination Product
25NDC:50580-726-741 in 1 CARTON11/01/2024
2590 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01983501/01/2008
Labeler - Kenvue Brands LLC (118772437)

Revised: 2/2025
Document Id: 2deb10c7-5fd4-da8a-e063-6294a90ae11d
Set id: b165db38-b302-4220-8627-77cb07bb078c
Version: 23
Effective Time: 20250211
 
Kenvue Brands LLC