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Zyrtec

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

Medically reviewed by Drugs.com. Last updated on Mar 1, 2022.

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:

  • 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)

Related/similar drugs

prednisone, montelukast, fluticasone nasal, loratadine, cetirizine, diphenhydramine, promethazine

Directions

adults and children 6 years and over 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

  • 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)

Zyrtec ALLERGY
cetirizine hydrochloride tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-726
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Cetirizine Hydrochloride (Cetirizine) Cetirizine Hydrochloride 10 mg
Inactive Ingredients
Ingredient Name Strength
Silicon Dioxide
Croscarmellose Sodium
Hypromellose, Unspecified
Lactose Monohydrate
Magnesium Stearate
Microcrystalline Cellulose
Polyethylene Glycol, Unspecified
Titanium Dioxide
Product Characteristics
Color WHITE Score 2 pieces
Shape RECTANGLE (rounded-off rectangular biconvex tablet) Size 9mm
Flavor Imprint Code Zyrtec;10;MG
Contains
Packaging
# Item Code Package Description
1 NDC:50580-726-03 50 BLISTER PACK in 1 CARTON
1 1 TABLET, FILM COATED in 1 BLISTER PACK
2 NDC:50580-726-13 3 BLISTER PACK in 1 CARTON
2 1 TABLET, FILM COATED in 1 BLISTER PACK
3 NDC:50580-726-30 5 BLISTER PACK in 1 PACKAGE
3 1 TABLET, FILM COATED in 1 BLISTER PACK
4 NDC:50580-726-32 14 BLISTER PACK in 1 PACKAGE
4 1 TABLET, FILM COATED in 1 BLISTER PACK
5 NDC:50580-726-36 1 BOTTLE, PLASTIC in 1 PACKAGE
5 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
6 NDC:50580-726-50 1 BOTTLE, PLASTIC in 1 PACKAGE
6 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
7 NDC:50580-726-51 2 BOTTLE, PLASTIC in 1 PACKAGE
7 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
8 NDC:50580-726-38 1 BOTTLE, PLASTIC in 1 PACKAGE
8 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
9 NDC:50580-726-70 1 BOTTLE, PLASTIC in 1 PACKAGE
9 70 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
10 NDC:50580-726-90 2 BOTTLE, PLASTIC in 1 PACKAGE
10 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
11 NDC:50580-726-66 75 TABLET, FILM COATED in 1 PACKAGE, COMBINATION
12 NDC:50580-726-40 1 BOTTLE, PLASTIC in 1 PACKAGE
12 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
13 NDC:50580-726-91 2500 POUCH in 1 CARTON
13 1 TABLET, FILM COATED in 1 POUCH
14 NDC:50580-726-92 50 POUCH in 1 TRAY
14 1 TABLET, FILM COATED in 1 POUCH
15 NDC:50580-726-93 3 POUCH in 1 CARTON
15 1 TABLET, FILM COATED in 1 POUCH
16 NDC:50580-726-94 1 BOTTLE in 1 PACKAGE
16 60 TABLET, FILM COATED in 1 BOTTLE
17 NDC:50580-726-95 1 BOTTLE in 1 PACKAGE
17 90 TABLET, FILM COATED in 1 BOTTLE
18 NDC:50580-726-96 5 POUCH in 1 CARTON
18 1 TABLET, FILM COATED in 1 POUCH
19 NDC:50580-726-97 14 POUCH in 1 CARTON
19 1 TABLET, FILM COATED in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019835 01/01/2008
Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

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Medical Disclaimer