Otc - Active Ingredient
Cetirizine HCl 10mg
Careall Allergy Relief Tablet
FDA Label NDC 51824-104
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by New World Imports for the product Careall Allergy Relief (NDC 51824-104). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antihistamine
Otc - Keep Out Of Reach Of Children
In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away
Indications & Usage
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 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 sedatives or tranquilizers
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.
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
Dosage & Administration
Adult and children over 6 years old: One 10mg tablet once daily: no more than one 10mg tablet in 24 hours. A 5mg 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
Inactive Ingredient
colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide
* Please review the disclaimer below.
