FDA Label for Cetirizine Hydrochloride
View Indications, Usage & Precautions
Cetirizine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Proficient Rx Lp. 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.
Active Ingredients (In Each Tablet)
Cetirizine HCl USP 5 mg
Purpose
Antihistimine
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
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 have liver 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)
Directions
|
|
|
|
|
|
|
|
Other Information
Store at 20° to 25°C (68° to 77°F)
[See USP Controlled Room Temperature].
Inactive Ingredients
hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide.
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
120004
Repackaged By;
Proficient Rx LP
Thousand Oaks 91320
Cetirizine Hydrochloride Tablets Usp 5 Mg
NDC 71205-093-30
Original Prescription Strength
Cetirizine Hydrochloride
Tablets 5 mg
30 Tablets
* Please review the disclaimer below.