Label: ALLERGY RELIEF- loratadine tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 68071-4318-3 - Packager: NuCare Pharmaceuticals,Inc.
- This is a repackaged label.
- Source NDC Code(s): 57896-788
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated February 16, 2021
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
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Warnings
Do not use if you have ever had an allergic reaction to this
product or any of its ingredients.
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.
Stop use and ask a doctor if an allergic reaction to this
product occurs. Seek medical help right away.
If pregnant or breast-feeding, ask a health professional before use.
- Directions
- Other information
- Inactive ingredients
- package label
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INGREDIENTS AND APPEARANCE
ALLERGY RELIEF
loratadine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68071-4318(NDC:57896-788) 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) Product Characteristics Color white Score no score Shape OVAL Size 8mm Flavor Imprint Code LOR;10;APO Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68071-4318-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 03/07/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076471 01/01/2008 Labeler - NuCare Pharmaceuticals,Inc. (010632300) Establishment Name Address ID/FEI Business Operations NuCare Pharamceuticals,Inc. 010632300 relabel(68071-4318)