Cetirizine Hydrochloride
Cetirizine Hydrochloride Tablets USP 5 mg, Allergy
ddec7d64-ab3d-4ddd-9bcd-b7f4d2b46be7
HUMAN PRESCRIPTION DRUG LABEL
Feb 21, 2022
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 (8)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Cetirizine HCL 5mg 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
INACTIVE INGREDIENT SECTION
INACTIVE INGREDIENTS
hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide.
OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENTS (IN EACH TABLET)
Cetirizine HCl USP 5 mg
OTC - PURPOSE SECTION
PURPOSE
Antihistimine
WARNINGS SECTION
WARNINGS:
DO NOT USE
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 DOCTOR
Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine if you need a different dose.
ASK DOCTOR/PHARMACIST
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.
WHEN USING THIS PRODUCT
- drowsines may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinary.
STOP 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
- 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 Poison Control Center right away. (1-800-222-1222)
DOSAGE & ADMINISTRATION SECTION
DIRECTIONS
|
Adults and children 6years 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 |
SPL UNCLASSIFIED SECTION
Manufactured by:
Unique Pharmaceutical Labs,
(A Div. of J. B. Chemicals & Pharmaceuticals Ltd.),
Mumbai 400 030, India.
Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816
M.L. G/1430 July 2020
129575
OTC - QUESTIONS SECTION
QUESTIONS
Call 1-844-874-7464
How Supplied Section
HOW SUPPLIED
NDC: 63629-4914-1: 30 Tablets in a BOTTLE