Active Ingredients
Active Ingredients (in each tablet) Purpose
Cetirizine HCl USP 10 mg................................................................Antihistimine
Cetirizine Hydrochloride Tablet
FDA Label NDC 16571-402
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rising Pharma Holdings, Inc. for the product Cetirizine Hydrochloride (NDC 16571-402). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, uses, warnings, otc - ask doctor, otc - ask doctor/pharmacist, when using this product, otc - stop use, if pregnant or breast-feeding:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
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.
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 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.
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 1-866-562-4597
Other
Manufactured for:
Rising Pharmaceuticals, Inc.
Allendale, NJ 07401
Manufactured by:
Unique Pharmaceutical Labs.
(A Div. of J. B. Chemicals & Pharmaceuticals Ltd.),
Mumbai 400 030, India
M.L G/1430 Nov. 2016
120005
Package Label.Principal Display Panel
———PRINCIPAL DISPLAY PANEL———
Rising® 16571-402-10
Original Prescription Strength
Cetirizine Hydrochloride Tablets USP 10 mg
6 yrs & older
100 Tablets
———PRINCIPAL DISPLAY PANEL———
Rising® 16571-402-50
Original Prescription Strength
Cetirizine Hydrochloride Tablets USP 10 mg
6 yrs & older
500 Tablets
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