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ZyrTEC (Cetirizine hydrochloride) Package Insert

Status:
Prescription (Rx) Facts
Strength:
10 mg
Other brand names:
Active ingredient:

Prescribing information (package insert) - ZyrTEC

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)

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

  • store between 20° to 25°C (68° to 77°F)
  • do not use if imprinted foil inner seal on bottle is broken or missing

Inactive ingredients

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

Questions?

call 1-800-343-7805

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 019835 · View the label on DailyMed

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for ZyrTEC

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Histamine-1 Receptor Antagonist
Active ingredient Cetirizine hydrochloride 10 mg
Dosage form Tablet, film coated
Route Oral
Marketing status not in the current FDA NDC Directory
Company (applicant) KENVUE BRANDS
FDA approval NDA 019835New Drug Application (NDA) Approved December 8, 1995
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Packages (NDC)
Package
10 mg – 30 in 1 bottle NDC 63629-2798-1
10 mg – 100 in 1 bottle NDC 63629-2798-2
10 mg – 15 in 1 bottle NDC 63629-2798-3

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.