RxRegimen check replace synthesize
Back to Library
FDA LABEL GENERIC: Cetirizine MFR: GLENMARK THERAPEUTICS INC., USA

Cetirizine Hcl 5 Mg Oral Tablet

Cetirizine HCl 5 mg

Cetirizine HCl 10 mg

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 an antihistamine containing hydroxyzine

Ask a doctor before useif 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)

DOSAGE AND ADMINISTRATION

Cetirizine Hydrochloride Tablets, USP 5 mg

adults and children 6 years and over

1 tablet (5 mg) or 2 tablets (10) once daily depending upon severity of symptoms; do not take more than 2 tablets (10) in 24 hours.

adults 65 years and over

1 tablet (5 mg) once a day; do not take more than 1 tablet (5 mg) in 24 hours.

children under 6 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

Cetirizine Hydrochloride Tablets, USP 10 mg

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

store between 20°C to 25°C (68°F to 77°F) do not use of imprinted foil inner seal on bottle is broken or missing. FDA approved organic impurities test procedure differs from USP

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

Questions or comments?

call toll-free weekdays 9 AM to 5 PM EST at 1 (888) 721-7115

Manufactured by:

Glenmark Pharmaceuticals Limited

Pithampur, Madhya Pradesh 454775, India

Distributed by:

Glenmark Therapeutics Inc., USA

Mahwah, NJ 07430

Product of India

February 2024

Package/Label Principal Display Panel

Container label

NDC 72657-129-35

10 mg - 365 Tablets

Package/Label Principal Display Panel

NDC 72657-128-35

5 mg- 365 Tablets

Principal Display Panel

Carton label

NDC 72657-129-35

10 mg - 365 Tablets

Principal Display Panel

NDC 72657-128-35

5 mg - 365 Tablets