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 Umasuto, Llc. 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.
Pupose
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 Useif 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 haveliver 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 aretaking 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.
Otc - Stop Use
Stop use and ask a doctorif 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
| 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 sever 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 1-866-768-0551
Other
Manufactured by:
Unique Pharmaceutical Laboratories
(A Div. of J. B. Chemicals & Pharmaceuticals Ltd.),
Mumbai 400 030, India
Distributed by:
Umasuto, LLC
14130 Minnesota Avenue, Bonner Springs,
KS 66012
Issued 03/2025
Principal Display Panel-100'S Count
UMASUTO NDC 85293-001-01
Original Prescription Strength
Cetirizine Hydrochloride Tablets USP 10 mg
Compare to the active ingredient in Zyrtec
Antihistamine
ALLERGY
Indoor & Outdoor Allergies
24 Hour Relief of:
•Sneezing
•Runny Nose
•Itchy, Watery Eyes
•Itchy Throat or Nose
6 yrs& older 100 Tablets
* Please review the disclaimer below.
