Skip to main content

Zyrtec Prescribing Information

Package insert / product label
Generic name: cetirizine hydrochloride
Dosage form: tablet, film coated
Drug class: Antihistamines

Medically reviewed by Drugs.com. Last updated on Aug 3, 2023.

Drug Facts

Active ingredient (in each tablet)

Cetirizine HCl 10 mg

Purpose

Antihistamine

Indications and Usage for Zyrtec

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

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)

Zyrtec Dosage and Administration

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

Storage and Handling

  • store between 20° to 25°C (68° to 77°F)
  • do not use if clamshell is opened, or if foil inner seal imprinted with "ZYRTEC®" is broken or missing
  • meets USP Dissolution Test 2

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

NDC 50580-726-36

ZYRTEC ®
ALLERGY

Cetirizine HCl tablets
10 mg /antihistamine

Indoor & Outdoor Allergies

24
hour

Relief of

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

30 Tablets
10 mg each

(Actual Size)

PRINCIPAL DISPLAY PANEL
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 CodeZYRTEC;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 PACKAGE01/01/200812/31/2022
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:50580-726-052500 in 1 CASE03/01/2023
201 in 1 POUCH; Type 0: Not a Combination Product
21NDC:50580-726-2550 in 1 CARTON03/01/2023
211 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01983501/01/2008
Labeler - Johnson & Johnson Consumer Inc. (878046358)

Frequently asked questions

View more FAQ

Medical Disclaimer