Cetirizine Hydrochloride
Cetirizine Hydrochloride
eb917099-fecf-6b55-e053-2995a90aaafa
HUMAN OTC DRUG LABEL
Sep 23, 2025
Marlex Pharmaceuticals, Inc
DUNS: 782540215
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 (9)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label
NDC 10135-0762-05
Allergy Relief
Cetirizine HCl Tablets, USP 10 mg
ANTIHISTAMINE
500 TABLETS
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
SPL UNCLASSIFIED SECTION
Manufactured for/ Distributed by:
Marlex Pharmaceuticals, Inc.
New Castle, DE 19720
Rev. 10/22 SP
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet)
Cetirizine HCl, USP 10 mg
OTC - PURPOSE SECTION
Purpose
Antihistamine
WARNINGS SECTION
Warnings
.
Do not useif 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 haveliver or kidney disease. Your doctor should determine if you need a different dose.
Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers.
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 ifan 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, contact a doctor or Poison Control Center (1-800-222-1222) right away.
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° and 25° C (68° and 77° F)
- do not use if imprinted safety seal under cap is broken or missing.
INACTIVE INGREDIENT SECTION
Inactive ingredients
corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide