Otc - Active Ingredient
Cetirizine HCl 5 mg
Cetirizine HCl 10 mg
Cetirizine Hcl Tablet
FDA Label NDC 72657-129
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Glenmark Therapeutics Inc., Usa for the product Cetirizine Hcl (NDC 72657-129). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, keep out of reach of children., dosage & administration, other information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antihistamine
Indications & 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
- If breast-feeding: not recommended
- if pregnant: ask a health professional before use.
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
If pregnant or breast-feeding:
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 & 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 |
Other Information
- 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
Inactive Ingredient
colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide
Other Safety Information
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
Principal Display Panel
NDC 72657-130-89
5 mg - 150 Tablets
(contains one bottle of 60 Tablets
and one bottle of 90 Tablets
5mgkit (5mgkit)
* Please review the disclaimer below.
