Drug Facts
Active ingredient (in each tablet)
Cetirizine Hydrochloride 10 mg
Cetirizine Hydrochloride 10 Mg Tablet, Film Coated
FDA Label NDC 10267-3579
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Contract Pharmacal Corp. for the product Cetirizine Hydrochloride 10 Mg (NDC 10267-3579). 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 drug facts, otc - purpose, uses, otc - do not use, otc - ask doctor, 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
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
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
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 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.
Otc - Questions
1-800-231-4670
Other
DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Manufactured by:
Contract Pharmacal Corp.
165 Oser Avenue
Hauppauge, NY 11788 USA
www.cpc.com
* This product is not manufactured or distributed by Kenvue Brands LLC., the owner of the registered trademark Zyrtec®.
Package Label.Principal Display Panel
NDC 10267-3579-6
*Compares to Zyrtec®Allergy Original Prescription Strength
Allergy
Cetirizine HCl Tablets, USP
10mg/ Antihistamine
Indoor & Outdoor Allergies
24 Hour
RELIEF OF
• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose
365 Tablets
10 mg each
* Please review the disclaimer below.
