Active Ingredient (In Each Capsule)
Cetirizine HCl 10 mg
Cetirizine Hcl Capsule
FDA Label NDC 36800-542
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Top Care (topco Associates Llc) for the product Cetirizine Hcl (NDC 36800-542). 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 ingredient (in each capsule), purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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 A Doctor Before Use If You Have
liver or kidney disease. Your doctor should determine if you need a different dose.
Ask A Doctor Or Pharmacist Before Use If You Are
taking tranquilizers or sedatives.
When Using This Product
- drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
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 a Poison Control Center right away.
Directions
| adults and children 6 years and over | one 10 mg capsule once daily; do not take more than one 10 mg capsule 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°-25°C (68°-77°F)
- avoid high humidity and excessive heat above 40°C (104°F)
- protect from light
Inactive Ingredients
FD&C yellow #6, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol, purified water, sodium hydroxide, sorbitan, sorbitol
Questions Or Comments?
call toll free 1-888-423-0139 (Mon - Fri 9AM - 5PM EST)
Other
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
KEEP THIS CARD FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
QUALITY GUARANTEED
This TopCare® product is laboratory tested to guarantee its highest quality. Your total satisfaction is guaranteed.
†This product is not manufactured or distributed by the owners of Zyrtec ®.
DISTRIBUTED BY TOPCO ASSOCIATES LLC
ITASCA, IL 60143 ©TOPCO BMAA0824
QUESTIONS? 1-888-423-0139
[email protected] www.topcarebrand.com
L0000898
R0924
Principal Display Panel
NDC 36800-542-86
TopCare®
health
COMPARE TO THE ACTIVE
INGREDIENT IN ZYRTEC®*
All-Day
Allergy
CETIRIZINE HCI CAPSULES, 10mg
ANTIHISTAMINE
Indoor & outdoor allergies
24-hour
RELIEF OF:
Sneezing
Runny nose
Itchy, watery eyes
Itchy throat or nose
actual size
25
SOFTGELS**
**LIQUID-FILLED CAPSULES
Front (Front)
Back (Back)
* Please review the disclaimer below.
