Active Ingredient (In Each Capsule)
Cetirizine HCl 10 mg
Cetirizine Hcl Capsule
FDA Label NDC 79481-0670
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Meijer Distribution Inc for the product Cetirizine Hcl (NDC 79481-0670). 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 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)
Other
*This product is not manufactured or distributed by Kenvue, Inc., owner of the registered trademark Zyrtec®.
TAMPER EVIDENT: DO NOT USE
IF IMPRINTED SAFETY SEAL UNDER
CAP IS BROKEN OR MISSING
KEEP THIS CARD FOR
COMPLETE WARNINGS AND
PRODUCT INFORMATION
DIST.
MEIJER DISTRIBUTION, INC.
GRAND RAPIDS, MI 49544
www.meijer.com
L0000909
R0924
Lot No.:
Exp. Date:
Principal Display Panel
NDC 79481-0670-2
meijer
Compare to the active ingredient in Zyrtec®*
24 Hour
Allergy
INDOOR & OUTDOOR
ALLERGIES
Cetitizine HCI
Capsules, 10mg
ANTIHISTAMINE
24 Hour Relief of:
• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose
25 softgels**
**Liquid-filled capsules
Actual Size
Image001 (Image001)
* Please review the disclaimer below.
