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Cetirizine Hydrochloride

Dosage form
TABLET
Labeler
Amneal Pharmaceuticals LLC
Label updated
2024-07-31
Retrieved
2026-09-07
Active ingredients
CETIRIZINE HYDROCHLORIDE
View original label and images on DailyMed ↗
Label information

Drug Facts

ACTIVE INGREDIENT

(in each tablet)

Cetirizine HCl, USP 10 mg

PURPOSE

Antihistamine

INDICATIONS AND USAGE

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 DOCTOR

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

ASK DOCTOR/PHARMACIST

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

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding:

• if breast-feeding: not recommended

• if pregnant: ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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)

DOSAGE AND ADMINISTRATION
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 sever 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

Other information

• store between 20 to 25°C (68 to 77°F)

INACTIVE INGREDIENT

Inactive ingredients

lactose monohydrate, magnesium stearate, polyvinyl alcohol, polyethylene glycol, povidone, starch, talc and titanium dioxide.

OTC - QUESTIONS

Questions or Comments?

Call 1-877-835-5472

Monday through Friday 9AM-5PM EST

Label information

Distributed by: 
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807

Rev. 07-2024-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

[Image in the official label — see DailyMed source]

Label information

[Image in the official label — see DailyMed source]

DailyMed Set ID: 273172b2-9aaf-46fb-a1ce-2961650eacd3 · Version 7
NDC: 65162-046