FDA Label for Cetirizine Hydrochloride
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- OTHER
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Cetirizine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Direct Rx. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredients (in each tablet) Purpose
Cetirizine HCl USP 10 mg................................................................Antihistimine
Otc - Purpose
Antihistamine
Indications & Usage
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 an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
Otc - Ask Doctor
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.
Otc - When Using
drowsines may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery.
Otc - Stop Use
Stop use and ask a doctor if an allergic reaction tothis product occurs. Seek medical help right away.
Otc - Pregnancy Or Breast Feeding
if breast-feeding: not recommended
if pregnant: ask a health professional before use.
Otc - Keep Out Of Reach Of Children
In case of overdose, get medical help or contact Poison Control Center right away.
Dosage & Administration
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 Safety Information
store at 20° to 25°C (68° to 77°F)
[See USP Controlled Room Temperature]
Inactive Ingredient
Hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide.
Otc - Questions
Call 1-866-562-4597
Other
Manufactured by:
Unique Pharmaceutical Labs.
(A Div. of J. B. Chemicals & Pharmaceuticals Ltd.),
Mumbai 400 030, India
Distributed by:
Rising Pharmaceuticals, Inc.
Saddle Brook, NJ 07663
M. L. G/1430 May 2018
120005
Package Label.Principal Display Panel
* Please review the disclaimer below.