LORATADINE
-
loratadine tablet
International Labs, Inc.
----------
Temporarily relieves the symptoms due to hay fever or other upper respiratory allergies:
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.
In case of overdose, get medical help or contat 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
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose
LORATADINE
loratadine tablet |
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
ANDA | ANDA076471 | 07/13/2009 | 10/28/2011 |
Labeler - International Labs, Inc. (023569924) |
Establishment | |||
Name | Address | ID/FEI | Operations |
International Labs, Inc. | 023569924 | RELABEL, REPACK |
Revised: 02/2012 International Labs, Inc.