Loratadine tablet

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
  • itchy, watery eyes
  • sneezing
  • 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 right away.

Directions

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?

1-800-206-7821

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

Packaging

# 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)

Establishment

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

Loratadine