Label: LORATADINE ANTIHISTAMINE- loratadine tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 66267-653-07, 66267-653-10, 66267-653-14, 66267-653-20, view more66267-653-30, 66267-653-60, 66267-653-90 - Packager: NuCare Pharmaceuticals,Inc.
- 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 11, 2021
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:66267-653(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, UNSPECIFIED (UNII: FZ989GH94E) 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:66267-653-07 7 in 1 BOTTLE; Type 0: Not a Combination Product 07/19/2017 2 NDC:66267-653-10 10 in 1 BOTTLE; Type 0: Not a Combination Product 07/19/2017 3 NDC:66267-653-14 14 in 1 BOTTLE; Type 0: Not a Combination Product 07/19/2017 4 NDC:66267-653-20 20 in 1 BOTTLE; Type 0: Not a Combination Product 07/19/2017 5 NDC:66267-653-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 07/19/2017 6 NDC:66267-653-60 60 in 1 BOTTLE; Type 0: Not a Combination Product 07/19/2017 7 NDC:66267-653-90 90 in 1 BOTTLE; Type 0: Not a Combination Product 07/19/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076301 10/15/2008 Labeler - NuCare Pharmaceuticals,Inc. (010632300) Establishment Name Address ID/FEI Business Operations NuCare Pharmaceuticals,Inc. 010632300 repack(66267-653)