Label: LORATADINE ALLERGY RELIEF- loratadine tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 63629-7772-1, 63629-7772-2, 63629-7772-3, 63629-7772-4, view more63629-7772-5, 63629-7772-6, 63629-7772-7, 63629-7772-8, 63629-7772-9 - Packager: Bryant Ranch Prepack
- 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 December 22, 2021
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 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?
- SPL UNCLASSIFIED SECTION
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HOW SUPPLIED
NDC: 63629-7772-1: 20 Tablets in a BOTTLE
NDC: 63629-7772-2: 30 Tablets in a BOTTLE
NDC: 63629-7772-3: 60 Tablets in a BOTTLE
NDC: 63629-7772-4: 14 Tablets in a BOTTLE
NDC: 63629-7772-5: 10 Tablets in a BOTTLE
NDC: 63629-7772-6: 90 Tablets in a BOTTLE
NDC: 63629-7772-7: 28 Tablets in a BOTTLE
NDC: 63629-7772-8: 15 Tablets in a BOTTLE
NDC: 63629-7772-9: 100 Tablets in a BOTTLE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LORATADINE ALLERGY RELIEF
loratadine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63629-7772(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:63629-7772-1 20 in 1 BOTTLE; Type 0: Not a Combination Product 07/30/2018 2 NDC:63629-7772-2 30 in 1 BOTTLE; Type 0: Not a Combination Product 07/02/2018 3 NDC:63629-7772-3 60 in 1 BOTTLE; Type 0: Not a Combination Product 11/22/2019 4 NDC:63629-7772-4 14 in 1 BOTTLE; Type 0: Not a Combination Product 12/11/2018 5 NDC:63629-7772-5 10 in 1 BOTTLE; Type 0: Not a Combination Product 07/05/2018 6 NDC:63629-7772-6 90 in 1 BOTTLE; Type 0: Not a Combination Product 07/05/2018 7 NDC:63629-7772-7 28 in 1 BOTTLE; Type 0: Not a Combination Product 12/22/2021 8 NDC:63629-7772-8 15 in 1 BOTTLE; Type 0: Not a Combination Product 12/22/2021 9 NDC:63629-7772-9 100 in 1 BOTTLE; Type 0: Not a Combination Product 06/21/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076134 11/01/2017 Labeler - Bryant Ranch Prepack (171714327) Registrant - Bryant Ranch Prepack (171714327) Establishment Name Address ID/FEI Business Operations Bryant Ranch Prepack 171714327 REPACK(63629-7772) , RELABEL(63629-7772)