Label: LORATADINE ALLERGY RELIEF- loratadine tablet
-
Contains inactivated NDC Code(s)
NDC Code(s): 64725-0526-1 - Packager: TYA Pharmaceuticals
- 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 June 18, 2012
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT(S)
- PURPOSE
- USE(S)
-
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
- INACTIVE INGREDIENTS
- QUESTIONS?
- LORATADINE ALLERGY RELIEF (LORATADINE) TABLET
-
INGREDIENTS AND APPEARANCE
LORATADINE ALLERGY RELIEF
loratadine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64725-0526(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:64725-0526-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 08/28/2003 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076134 08/28/2003 Labeler - TYA Pharmaceuticals (938389038) Registrant - TYA Pharmaceuticals (938389038) Establishment Name Address ID/FEI Business Operations TYA Pharmaceuticals 938389038 RELABEL(64725-0526) , REPACK(64725-0526)