Label: LORATADINE tablet
-
Contains inactivated NDC Code(s)
NDC Code(s): 10544-455-30 - Packager: Blenheim Pharmacal, Inc.
- This is a repackaged label.
- Source NDC Code(s): 60505-0147
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated February 23, 2015
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- Uses
-
Warnings
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.
- Directions
- Other information
- Inactive ingredients
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
LORATADINE
loratadine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10544-455(NDC:60505-0147) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE 10 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) Product Characteristics Color white Score no score Shape OVAL Size 8mm Flavor Imprint Code LOR;10;APO Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10544-455-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/09/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076471 02/09/2014 Labeler - Blenheim Pharmacal, Inc. (171434587) Registrant - Blenheim Pharmacal, Inc. (171434587) Establishment Name Address ID/FEI Business Operations Blenheim Pharmacal, Inc. 171434587 repack(10544-455)