Allergy Relief Non Drowsy
FDA Label NDC 52904-430

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Select Corporation for the product Allergy Relief Non Drowsy (NDC 52904-430). 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, dosage & administration, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, 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

Active Ingredients

Loratadine USP 10 mg

Otc - Purpose

Antihistamine

Dosage & Administration

Directions: • Adults and children 6 years and over: • 1
tablet daily; not more than 1 tablet in 24 hours • Children under
6 years of age: • ask a doctor

Indications & Usage

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

Warnings:Do not use: • if you have ever had an allergic reaction to thisproduct or any of its ingredients Ask a doctor before use if youhave: liver or kidney disease. Your doctor should determine ifyou need a different dose. When using this product: • do nottake more than directed. Taking more than directed may causedrowsiness. Stop use and ask a doctor if: • an allergic reactionto this product occurs. Seek medical help right away.

Otc - Pregnancy Or Breast Feeding

If pregnant or
breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.

Inactive Ingredient

Inactive
ingredients: corn starch, lactose monohydrate,
magnesium stearate, pregelatinized starch

Package Label.Principal Display Panel

MM1

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