Label: LORATADINE ALLERGY RELIEF- loratadine tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 68071-3208-1, 68071-3208-2, 68071-3208-3, 68071-3208-4, view more68071-3208-6, 68071-3208-7, 68071-3208-9 - Packager: NuCare 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 February 11, 2021
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT(S)
- PURPOSE
- USE(S)
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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?
- 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:68071-3208(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:68071-3208-1 10 in 1 BOTTLE; Type 0: Not a Combination Product 05/17/2017 2 NDC:68071-3208-4 14 in 1 BOTTLE; Type 0: Not a Combination Product 05/17/2017 3 NDC:68071-3208-7 7 in 1 BOTTLE; Type 0: Not a Combination Product 05/17/2017 4 NDC:68071-3208-2 20 in 1 BOTTLE; Type 0: Not a Combination Product 05/17/2017 5 NDC:68071-3208-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/17/2017 6 NDC:68071-3208-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 05/17/2017 7 NDC:68071-3208-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/17/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076134 08/28/2003 Labeler - NuCare Pharmaceuticals, Inc. (010632300) Establishment Name Address ID/FEI Business Operations NuCare Pharmaceuticals, Inc. 010632300 repack(68071-3208)