Active Ingredient
Cetirizine HCl 10 mg
Medline Industries Tablet, Film Coated
FDA Label NDC 53329-036
16 label sections · Submitted to the FDA by Medline Industries, Lp · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Medline Industries, Lp for the product Medline Industries (NDC 53329-036). 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, purpose, uses, warnings, 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
Warnings
Do not use if you have ever had any 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
- 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)
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 |
Other Information
- store between 20-25°C (68-77°F)
- do not use if printed foil under cap is broken or missing
Inactive Ingredients
corn starch, FD&C blue no.1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, polydextrose, polyethylene glycol, povidone, titanium dioxide, triacetin
Questions Or Comments?
call 1-800-MEDLINE (633-5463)
Monday - Friday, 7 a.m. to 7 p.m. CST
Manufacturing Information
**This product is not manufactured or
distributed by Kenvue, Inc., ownder of
the registered trademark Zyrtec®
www.medline.com ©2026 Medline
Manufactured for: Medline Industries, LP
Three Lakes Drive, Northfield, IL 60093 USA
1-800 MEDLINE
Other Safety Information
IMPORTANT: READ ALL PRODUCT INFORMATION
BEFORE USING. KEEP THIS PACKAGE FOR
IMPORTANT INFORMATION
DO NOT USE IF PRINTED FOIL
UNDER CAP IS BROKEN OR MISSING
* Please review the disclaimer below.
