Loratadine odt tablet, orally disintegrating

Drug facts

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

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 (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 25C (68 to 77F)
  • 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?

DISTRIBUTED BY: Walmart Inc,.
Bentonville, AR 72716
This Product is not manufactured or distributed
by Bayer HealthCare LLC, distributor of claritin ®RediTabs ®

Manufactured for :
AUROHEALTH LLC
2572 Brunswick Pikg
Lawrenceville, NJ 08684

Manufacturedby :
Aurobindo Pharma Limited
Unit- VII (SEZ)
Mahabubnagar (Dt) -509302
India

Ingredients and appearance - Product information

Loratadine odt tablet, orally disintegrating- Loratadine

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 49035-806
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Loratadine ( UNII: 7AJO3BO7QN)( Loratadine - UNII: 7AJO3BO7QN ) 10 mgin 1

Inactive Ingredients

Ingredient Name Code
Aspartame ( UNII: Z0H242BBR1)
Crospovidone (15 mpa.s at 5%) ( UNII: 68401960MK)
Mannitol ( UNII: 3OWL53L36A)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Peppermint ( UNII: V95R5KMY2B)
Starch, corn ( UNII: O8232NY3SJ)
Sodium stearyl fumarate ( UNII: 7CV7WJK4UI)

Product Characteristics

Color WHITE (White to Off-white) Shape ROUND (Biconvex)
Size 8 mm Score 1
Imprint Code K;9 Flavor PEPPERMINT

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA208477 USA

Labeler - Wal-Mart Stores, Inc.( 051957769)

Establishment

Name ID/FEI Business Operations
Wal-Mart Stores, Inc. 051957769 ANALYSIS( 49035-806), MANUFACTURE( 49035-806)

Package label-principal display panel - 10 mg, blister carton 30 (3 x 10) orally disintegratingtablets

NDC 49035-806-09

equate TM

Compared to
the active

Ingredient

In Claritin ®

RediTabs ®**

Non-Drowsy*

Loratadine Orally DisintegratingDissolves

Tablets USP 10 mgin Your Mouth
Antihistamine

Indoor & Outdoor Allergy Relief

24 Hour Relief Of:

  • Sneezing
  • Runny nose 24
  • Itchy, watery eyes HOUR
  • Itchy throat or nose

Original Prescription Strength

30
*When taken as directed. See Drug Facts Panel. TABLETS (3 x 10) Orally Disintegrating Tablets