Otc - Active Ingredient
Cetirizine Hydrochloride 10 mg
Cetirizine Hydrochloride Tablet
FDA Label NDC 81469-353
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by First Nation Group, Llc for the product Cetirizine Hydrochloride (NDC 81469-353). 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 otc - active ingredient, otc - purpose, uses, warnings, otc - do not use, otc - ask doctor/pharmacist, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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
Otc - Do Not Use
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/Pharmacist
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 sedatives or tranquilizers.
Otc - When Using
When using this product
- drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery.
Otc - Stop Use
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding:
- if breast-feeding: not recommended
- if pregnant: ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 between 20° to 25°C (68° to 77°F)
Inactive Ingredient
Hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate, povidone, pregelatinized starch, and titanium dioxide.
Questions
1-855-221-5332: Weekdays 9AM - 5PM EST
Other
DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Manufactured For: First Nation Group, LLC
4566 E Highway 20, Suite #208, Niceville, FL 32578-8839
* This product is not manufactured or distributed by Kenvue Brands LLC., the owner of the registered trademark Zyrtec®.
Package Label.Principal Display Panel
NDC 81469-353-01
Compares to Zyrtec®Allergy Original Prescription Strength
Indoor & Outdoor Allergies
Cetirizine HCl
Tablets, USP 100 Tablets
10mg/ Antihistamine
24 Hour
Relief of Sneezing, Runny Nose,
Itchy, Watery Eyes, Itchy Throat or Nose
FIRSTNATION Group
* Please review the disclaimer below.
