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 St. Mary's Medical Park Pharmacy. 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
Active Ingredients (in each tablet) Purpose
Cetirizine HCl USP 10 mg................................................................Antihistimine
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 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 tothis 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.
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 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 1-844-874-7464
Other
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 Jul. 2020
126406
Principal Display Panel-100'S Count
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