Drugplain

Zyrtec 10 mg/1

Cetirizine Hydrochloride · TABLET, CHEWABLE · Kenvue Brands LLC

No Recall History
Plain English

Zyrtec (cetirizine) is an antihistamine tablet taken by mouth to relieve allergy symptoms such as sneezing, itching, watery eyes, and runny nose. It is available over-the-counter in regular and chewable tablet forms.

Key Facts

Brand Name
Zyrtec
Generic Name
Cetirizine Hydrochloride
NDC Code (Product)
50580-753
Manufacturer
Kenvue Brands LLC
Strength
10 mg/1
Dosage Form
TABLET, CHEWABLE
Route
ORAL
Marketing Status
Application #
NDA021621
Marketing Start
06/20/2022

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective17,775 reports
fatigue14,505 reports
pain12,502 reports
off label use11,028 reports
headache9,944 reports
rash9,831 reports
pruritus9,037 reports
nausea8,927 reports
alopecia8,527 reports
abdominal discomfort8,405 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

Directions may be taken with or without water chew or crush tablets completely before swallowing children 2 to under 6 years of age Chew and swallow 1 tablet (2.5 mg) once daily; If needed, dose can be increased to a maximum of 2 tablets (5 mg) once daily or 1 tablet (2.5 mg) every 12 hours. Do not give more than 2 tablets (5 mg) in 24 hours. adults and children 6 years and over Chew and swallow 2 tablets (5 mg) or 4 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 4 tablets (10 mg) in 24 hours. adults 65 years and over Chew and swallow 2 tablets (5 mg) once daily; do not take more than 2 tablets (5 mg) in 24 hours. children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Warnings

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)

Frequently Asked Questions

What is Zyrtec used for?

Zyrtec (cetirizine) is an antihistamine tablet taken by mouth to relieve allergy symptoms such as sneezing, itching, watery eyes, and runny nose. It is available over-the-counter in regular and chewable tablet forms.

Is Zyrtec a controlled substance?

Zyrtec is not classified as a controlled substance by the DEA.

What is the generic name for Zyrtec?

The generic name for Zyrtec is Cetirizine Hydrochloride. There are 12 other brand versions of Cetirizine Hydrochloride.

What is the NDC code for Zyrtec 10 mg/1?

The NDC (National Drug Code) for Zyrtec 10 mg/1 is 50580-753, listed by Kenvue Brands LLC.