Loratadine odt tablet, orally disintegrating

Drug facts

Active ingredient (in each tablet)

Loratadine USP 10 mg




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.


  • 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:


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

Labeler - Aurohealth LLC( 078728447)


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

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

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