cetirizine hydrochloride
Perrigo Cetirizine Hydrochloride Tablets 10 mg Drug Facts
ae93976d-de9b-43a6-b299-ce1f1ae8d6f8
HUMAN OTC DRUG LABEL
May 21, 2025
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cetirizine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (11)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Cetirizine Hydrochloride 10mg Tablet
INDICATIONS & USAGE SECTION
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
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet)
Cetirizine HCl 10 mg
OTC - PURPOSE SECTION
Purpose
Antihistamine
WARNINGS SECTION
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)
DOSAGE & ADMINISTRATION SECTION
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 |
STORAGE AND HANDLING SECTION
Other information
•
store between 20 - 25°C (68 - 77°F)
•
do not use if printed foil under cap is broken or missing
INACTIVE INGREDIENT SECTION
Inactive ingredients
corn starch, FD&C blue no. 1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, polydextrose, polyethylene glycol, povidone, titanium dioxide, triacetin
OTC - QUESTIONS SECTION
Questions or comments?
1-800-719-9260
How Supplied Section
HOW SUPPLIED
Cetirizine Hydrochloride 10mg Tablet
- NDC 72162-2173-2: 300 Tablets in a BOTTLE
- NDC 72162-2173-3: 30 Tablets in a BOTTLE
Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504