Active Ingredient (In Each Caplet)
Cetirizine HCl 10 mg
Allergy Relief Tablet
FDA Label NDC 84324-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nuvicare Llc for the product Allergy Relief (NDC 84324-001). 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 caplet), purpose, uses:, warnings:, directions, other lnformation, inactive ingredients, questions or comments?, 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
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.
Directions
Adults and children 6 years and older: 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 Lnformation
- Store between 20°Cto 25°C(68°F to 77°F)
Inactive Ingredients
Lactose, Povidone, Maize Starch, Magnesium Stearate, Opadry White, Titanium Dioxide, Hypromellose, Polyethylene Glycol
Questions Or Comments?
Call 1 (718) 337-8733 or visit [email protected]
* Please review the disclaimer below.
