Loratadine
FDA Label NDC 61919-142

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Directrx for the product Loratadine (NDC 61919-142). 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 uses, active ingredient in each tablet, purpose, warnings, inactive ingredients, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Uses

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

  • runny nosesneezing
  • itchy, watery eyes
  • itching of the nose or throat

Active Ingredient In Each Tablet

Loratadine 10 mg

Purpose

Antihistamine

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.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Inactive Ingredients

Inactive ingredients

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

Principal Display Panel

Compare to Claritin® active ingredient

Loratadine Tablets, 10 mg

Antihistamine

24 Hour

Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

Indoor & Outdoor Allergies

Non-Drowsy*

*When taken as directed. See Drug Facts Panel.

10mg Label Image:

Image Description (Loratadine10,90)

Image Description (Loratadine10,90)

* Please review the disclaimer below.