Active Ingredient (In Each Tablet)
Cetirizine hydrochloride USP, 5 mg
Cetirizine Hydrochloride Tablet, Film Coated
FDA Label NDC 0378-3635
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mylan Pharmaceuticals Inc. for the product Cetirizine Hydrochloride (NDC 0378-3635). 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 active ingredient (in each tablet), purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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.
Directions
adults and children 6 years and over | 1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours. |
adults 65 years and over | 1 tablet once a day; do not take more than 1 tablet in 24 hours |
children under 6 years of age | ask a doctor |
consumers with liver or kidney disease | ask a doctor |
Other Information
- store between 20° to 25°C (68° to 77°F)
Inactive Ingredients
Anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, and triacetin
Questions?
Call 1-877-446-3679 (1-877-4-INFO-RX)
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505
Package Label.Principal Display Panel
PRINCIPAL DISPLAY PANEL - 5 mg Allergy
NDC 0378-3635-01
Cetirizine HCl
Tablets, USP
Allergy
5 mg
Antihistamine
Indoor & Outdoor Allergies
24 Hour Relief of
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
RM-AR3635A5 100 Tablets
Tamper Evident: do not use if foil seal
under cap is missing, open or broken.
PRINCIPAL DISPLAY PANEL - 10 mg Allergy
NDC 0378-3637-01
Cetirizine HCl
Tablets, USP
Allergy
10 mg
Antihistamine
Indoor & Outdoor Allergies
24 Hour Relief of
RM-AR3637A5 100 Tablets
Tamper Evident: do not use if foil seal
under cap is missing, open or broken.
Active Ingredient (in each tablet)
Cetirizine hydrochloride USP, 10 mg
Directions | |
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 |
* Please review the disclaimer below.
