Label: LORATADINE ANTIHISTAMINE- loratadine tablet
- NDC Code(s): 0615-8217-39
- Packager: NCS HealthCare of KY, LLC dba Vangard Labs
- This is a repackaged label.
- Source NDC Code(s): 45802-650
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 16, 2024
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
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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
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INGREDIENTS AND APPEARANCE
LORATADINE ANTIHISTAMINE
loratadine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0615-8217(NDC:45802-650) 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) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color white Score no score Shape OVAL Size 8mm Flavor Imprint Code L612 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0615-8217-39 30 in 1 BLISTER PACK; Type 0: Not a Combination Product 07/11/2018 11/30/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076301 07/11/2018 11/30/2024 Labeler - NCS HealthCare of KY, LLC dba Vangard Labs (050052943) Establishment Name Address ID/FEI Business Operations NCS HealthCare of KY, LLC dba Vangard Labs 050052943 repack(0615-8217)