Label: ALLERGY RELIEF NON DROWSY- loratadine tablet
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NDC Code(s):
71335-1651-1,
71335-1651-2,
71335-1651-3,
71335-1651-4, view more71335-1651-5, 71335-1651-6, 71335-1651-7, 71335-1651-8, 71335-1651-9
- Packager: Bryant Ranch Prepack
- This is a repackaged label.
- Source NDC Code(s): 69230-317
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 4, 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?
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HOW SUPPLIED
NDC: 71335-1651-1: 20 Tablets in a BOTTLE, PLASTIC
NDC: 71335-1651-2: 30 Tablets in a BOTTLE, PLASTIC
NDC: 71335-1651-3: 60 Tablets in a BOTTLE, PLASTIC
NDC: 71335-1651-4: 14 Tablets in a BOTTLE, PLASTIC
NDC: 71335-1651-5: 10 Tablets in a BOTTLE, PLASTIC
NDC: 71335-1651-6: 90 Tablets in a BOTTLE, PLASTIC
NDC: 71335-1651-7: 28 Tablets in a BOTTLE, PLASTIC
NDC: 71335-1651-8: 15 Tablets in a BOTTLE, PLASTIC
NDC: 71335-1651-9: 100 Tablets in a BOTTLE, PLASTIC
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ALLERGY RELIEF NON DROWSY
loratadine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71335-1651(NDC:69230-317) 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) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) Product Characteristics Color white Score no score Shape ROUND Size 6mm Flavor Imprint Code 439 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71335-1651-1 20 in 1 BOTTLE; Type 0: Not a Combination Product 07/27/2020 2 NDC:71335-1651-2 30 in 1 BOTTLE; Type 0: Not a Combination Product 07/16/2020 3 NDC:71335-1651-3 60 in 1 BOTTLE; Type 0: Not a Combination Product 10/16/2020 4 NDC:71335-1651-4 14 in 1 BOTTLE; Type 0: Not a Combination Product 05/25/2022 5 NDC:71335-1651-5 10 in 1 BOTTLE; Type 0: Not a Combination Product 01/12/2021 6 NDC:71335-1651-6 90 in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2020 7 NDC:71335-1651-7 28 in 1 BOTTLE; Type 0: Not a Combination Product 04/04/2024 8 NDC:71335-1651-8 15 in 1 BOTTLE; Type 0: Not a Combination Product 04/04/2024 9 NDC:71335-1651-9 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/14/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075209 12/27/2019 Labeler - Bryant Ranch Prepack (171714327) Registrant - Bryant Ranch Prepack (171714327) Establishment Name Address ID/FEI Business Operations Bryant Ranch Prepack 171714327 REPACK(71335-1651) , RELABEL(71335-1651)