Label: LORATADINE ALLERGY RELIEF- loratadine tablet
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NDC Code(s):
55289-728-10,
55289-728-15,
55289-728-20,
55289-728-30, view more55289-728-60, 55289-728-90
- Packager: PD-Rx Pharmaceuticals, Inc.
- This is a repackaged label.
- Source NDC Code(s): 51660-526
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 12, 2024
If you are a consumer or patient please visit this version.
- 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 haveliver or kidney disease. Your doctor should determine if you need a different dose.
When using this productdo not take more than directed. Taking more than directed may cause drowsiness.
- Directions
- Other Information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL - 10 mg Tablet
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INGREDIENTS AND APPEARANCE
LORATADINE ALLERGY RELIEF
loratadine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55289-728(NDC:51660-526) 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 STARCH, CORN (UNII: O8232NY3SJ) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white (White to Off White) Score no score Shape ROUND Size 6mm Flavor Imprint Code RX526 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55289-728-10 10 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/30/2020 2 NDC:55289-728-15 15 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/27/2021 3 NDC:55289-728-20 20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/27/2021 4 NDC:55289-728-30 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/06/2018 5 NDC:55289-728-60 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/18/2023 6 NDC:55289-728-90 90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/06/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076134 11/01/2017 Labeler - PD-Rx Pharmaceuticals, Inc. (156893695) Registrant - PD-Rx Pharmaceuticals, Inc. (156893695) Establishment Name Address ID/FEI Business Operations PD-Rx Pharmaceuticals, Inc. 156893695 repack(55289-728)