Loratadine Tablet, Orally Disintegrating
FDA Label NDC 11822-0919

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid Corporation for the product Loratadine (NDC 11822-0919). 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 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 over1 tablet daily; not more than 1 tablet in 24 hourschildren under 6 years of ageask a doctorconsumers with liver or kidney diseaseask a doctor
     
     
     
     
     
     

Other Information

  • do not use in printed blister unit is broken or torn
  • store between 20° to 25°C (68° to 77°F)
  • use tablet immediately after opening individual blister

Inactive Ingredients

croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, natural and artificial mint flavor, sucralose

Questions Or Comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to the active ingredient in Claritin® RediTabs®

FOR JUNIORS & UP AGES 6 YEARS & OLDER

ORIGINAL PRESCRIPTION STRENGTH

LORATADINE

ORALLY DISINTEGRATING TABLETS, 10 mg

ANTIHISTAMINE

NON-DROWSY*

INDOOR & OUTDOOR ALLERGIES

24 HOUR RELIEF OF

Sneezing – Runny nose – Itchy, watery eyes

Itchy throat or nose

24 Hour

ACTUAL SIZE

NO WATER NEEDED

MELTS IN TOUR MOUTH

*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.

30 TABLETS

Loratadine Image (Image 01)

Loratadine Image (Image 01)

* Please review the disclaimer below.