Loratadine Odt Tablet, Orally Disintegrating
FDA Label NDC 49035-806

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores, Inc. for the product Loratadine Odt (NDC 49035-806). 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
  • sneezing
  • itchy, watery eyes
  • 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 (1-800-222-1222) right away.

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 2.25 mg per tablet
  • do not use if the individual blister unit is open or torn
  • store at 20° to 25°C (68° to 77°F)
  • use tablet immediately after opening individual blister
  • Complies with USP test 2 for Disintegration

Inactive Ingredients

aspartame, crospovidone, mannitol, microcrystalline cellulose,  peppermint, pregelatinized starch (maize), sodium stearyl fumarate

Questions Or Comments?

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Package Label-Principal Display Panel - 10 Mg, Blister Carton 10 (1 X 10) Orally Disintegrating Tablets

NDC 49035-806-03

equateTM

Compare
to Claritin®
RediTabs®
active
ingredient**

children's Non-Drowsy*

LORATADINE ORALLY
DISINTEGRATING
Tablets USP 10 mg
Antihistamine

FOR CHILDREN SIX YEARS OF AGE OR OLDER

Indoor & Outdoor
Allergies

LASTS UP TO
24
HOURS

Relief of:

Sneezing
Runny Nose                                           Dissolves in
Itchy, Watery Eyes                               Your Mouth
Itchy Throat or Nose

*When taken as directed.                     Original
See Drug Facts Panel.                          Prescription Strength

10 (1X10) Orally Disintegrating Tablets

Figure1 (Loratadine Fig1)

Figure1 (Loratadine Fig1)

* Please review the disclaimer below.