Careall Allergy Relief Tablet
FDA Label NDC 51824-103

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 51824-103). 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 - Active Ingredient

Loratadine 10mg

Otc - Purpose

Antihistamine

Otc - Keep Out Of Reach Of Children

In case of accidental overdose, contact a doctor or Poison Control Center right away (1-800-222-1222)

Indications & Usage

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose, itchy/watery eyes, sneezing, 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.

Ask a doctor before use if you have liver or kidney disease.  Your doctor should determine if you need a different dose.

When using this product do not take more than directed.  Taking more than directed may cause drowsiness.

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: 1 tablets daily: no more than 1 tablet in 24 hours.

Children under 6 years of age: ask a doctor

Consumers with liver or kidney disease: ask a doctor

Inactive Ingredient

lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate.  

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