Loratadine tablet

Active ingredient (in each tablet)

Loratadine, USP 10 mg




Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • itchy, watery eyes
  • sneezing
  • 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 right away.


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

  • Safety sealed: do not use if the imprinted bottle seal is open or torn (for bottle only).
  • Safety sealed: do not use if open or torn (for blister package only).

Storage and handling section

  • Store at 20 to 25C (68 to 77F) (see USP Controlled Room Temperature).

Inactive ingredients

Lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

Questions or comments?


Spl unclassified section

© 2005 NorthStar Healthcare HoldingsI10-2015M

Manufactured for: Northstar Rx LLC

Memphis, TN 38141.

Manufactured by: Sandoz Inc.

Princeton, NJ 08540.

How supplied

Product: 50090-3620

NDC: 50090-3620-0 10 TABLET in a BOTTLE

NDC: 50090-3620-3 15 TABLET in a BOTTLE, PLASTIC

NDC: 50090-3620-4 30 TABLET in a BOTTLE, PLASTIC

NDC: 50090-3620-5 90 TABLET in a BOTTLE, PLASTIC

NDC: 50090-3620-1 20 TABLET in a BOTTLE, PLASTIC

NDC: 50090-3620-6 7 TABLET in a BOTTLE, PLASTIC

Ingredients and appearance - Product information

Loratadine tablet- Loratadine

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 50090-3620
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
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Sodium starch glycolate type a potato ( UNII: 5856J3G2A2)

Product Characteristics

Color WHITE (white to off white) Size 6 mm
Shape ROUND Score 1
Imprint Code GG296


# Item Code Package Description Marketing Start Date
1 NDC: 50090-3620-0 10 in 1 BOTTLE 2018/11/15
2 NDC: 50090-3620-3 15 in 1 BOTTLE, PLASTIC 2016/02/01
3 NDC: 50090-3620-4 30 in 1 BOTTLE, PLASTIC 2016/02/01
4 NDC: 50090-3620-5 90 in 1 BOTTLE, PLASTIC 2016/02/01
5 NDC: 50090-3620-1 20 in 1 BOTTLE, PLASTIC 2016/02/01
6 NDC: 50090-3620-6 7 in 1 BOTTLE, PLASTIC 2016/02/01

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA075209 USA 2016/02/01

Labeler - A-S Medication Solutions( 830016429)


Name ID/FEI Business Operations
A-S Medication Solutions 830016429 RELABEL( 50090-3620), REPACK( 50090-3620)