Label: LORATADINE tablet
- NDC Code(s): 60505-0147-1, 60505-0147-8
- Packager: Apotex Corp.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 3, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- Uses
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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
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 10 mg
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INGREDIENTS AND APPEARANCE
LORATADINE
loratadine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) 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) MICROCRYSTALLINE CELLULOSE (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:60505-0147-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/24/2005 06/30/2022 2 NDC:60505-0147-8 1000 in 1 BOTTLE; Type 0: Not a Combination Product 01/24/2005 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076471 01/24/2005 Labeler - Apotex Corp. (845263701)