Loratadine Odt Tablet, Orally Disintegrating
FDA Label NDC 46122-539

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amerisource Bergen for the product Loratadine Odt (NDC 46122-539). 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?

call 1-855-274-4122



Distributed By

AmerisourceBergen

1300 Morris Drive

Chesterbrook, PA 19087

Questions or Concerns?

www.mygnp.com 



  

 









Package Label-Principal Display Panel - 10 Mg, Blister Carton 10 Orally Disintegrating Tablets

GOOD NEIGHBOR PHARMACY®

Compare to Claritin® RediTabs® active ingredient**

NDC  46122-539-52
Original Prescription Strength
Non-Drowsy*
24 HR
Loratadine Orally Disintegrating
Tablets USP 10 mg
Antihistamine

No Water Needed

 Melts in Your Mouth

Indoor & Outdoor Allergies

Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose


    • *When taken as directed. See Drug Facts Panel.

    actual size

    10 Orally Disintegrating Tablets



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

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


* Please review the disclaimer below.