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?

call 1-855-274-4122

Distributed by:

AUROHEALTH LLC

2572 Brunswick Pike

Lawrenceville, NJ 08648

Made in India

Code: TS/DRUGS/22/2009

Ingredients and appearance - Product information

Loratadine odt tablet, orally disintegrating- Loratadine

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 58602-744
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 (120 .mu.m) ( 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 - Aurohealth LLC( 078728447)

Establishment

Name ID/FEI Business Operations
Aurohealth LLC 078728447 ANALYSIS( 58602-744), MANUFACTURE( 58602-744)

Package label-principal display panel - 10 mg, blister carton 10 (1 x 10) orally disintegrating tablets

AUROHEALTH
NDC 58602-744-83
**Compare to the active ingredient in Claritin ®RediTabs ®
Original Prescription Strength
Non-Drowsy*
Loratadine Orally Disintegrating
Tablets USP 10 mg
Antihistamine
Indoor & Outdoor Allergies

24Hour
Relief of:

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

No Water Needed
Melts in Your Mouth


*When taken as directed. See Drug Facts Panel.

10 (1 X 10) Orally Disintegrating Tablets