Label: LORATADINE tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 53808-0457-1 - Packager: State of Florida DOH Central Pharmacy
- This is a repackaged label.
- Source NDC Code(s): 45802-0650
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated May 26, 2010
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient (in each tablet)
- Purpose
- Uses
- How supplied
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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?
- 10 mg Label
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INGREDIENTS AND APPEARANCE
LORATADINE
loratadine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53808-0457(NDC:45802-0650) 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 LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color WHITE Score no score Shape OVAL Size 6mm Flavor Imprint Code L612 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53808-0457-1 30 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076301 07/01/2009 Labeler - State of Florida DOH Central Pharmacy (829348114) Establishment Name Address ID/FEI Business Operations State of Florida DOH Central Pharmacy 829348114 repack