Loratadine
FDA Label NDC 0363-0527

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Company for the product Loratadine (NDC 0363-0527). 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 tablet), purpose, uses, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Tablet)

Loratadine USP, 10 mg

Purpose

Antihistamine

Uses

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

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 (1-800-222-1222).

Directions

  • place 1 tablet on tongue; tablet disintegrates, with or without water

    • 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

    consumers with liver or kidney disease

    ask a doctor

Other Information

  • Phenylketonurics: Contains Phenylalanine 0.6 mg Per Tablet.
  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
  • store between 20° to 25° C (68° to 77° F). Protect from excessive moisture.
  • use tablet immediately after opening individual blister.

Inactive Ingredients

Aspartame, croscarmellose sodium, magnesium stearate, mannitol, mint flavor, sodium stearyl fumarate, strawberry cream flavor, tutti-frutti flavor

Questions?

Call 1-800-406-7984

Principal Display Panel

NON-DROWSY*

Well at Walgreens

NDC 0363-0527-71

Wal-itin®

WALGREENS PHARMACIST RECOMMENDED‡

24 Hour Allergy Relief

Fast Dissolving Tablets

Loratadine Orally Disintegrating Tablets USP, 10 mg

Antihistamine

  • Relief of runny nose, sneezing, Itchy throat or nose & Itchy, watery eyes
  • Ages 6 years & older

    • 70 TABLETS

    INDOOR/OUTDOOR ALLERGIES

    24 HOUR

    Compare to Claritin®RediTabs® active ingredient‡‡

    ORALLY DISINTEGRATING TABLETS

    *When taken as directed.

    See Drug Facts Panel.

    DISTRIBUTED BY: WALGREEN CO.

    200 WILMOT RD., DEERFIELD, IL 60015

    5115100/ORG0315-F

    This Is The 10 Count Blister Carton Label For Walgreens Loratadine Odt. (Loraodt)

    This Is The 10 Count Blister Carton Label For Walgreens Loratadine Odt. (Loraodt)

* Please review the disclaimer below.