Label: LEADER LORATADINE- loratadine tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 37205-346-47, 37205-346-52, 37205-346-60, 37205-346-65, view more37205-346-72, 37205-346-75 - Packager: Cardinal Health
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 19, 2012
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- 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?
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
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INGREDIENTS AND APPEARANCE
LEADER LORATADINE
loratadine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-346 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) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) 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:37205-346-52 10 in 1 BLISTER PACK 2 NDC:37205-346-60 20 in 1 BLISTER PACK 3 NDC:37205-346-65 30 in 1 BLISTER PACK 4 NDC:37205-346-72 60 in 1 BOTTLE 5 NDC:37205-346-75 90 in 1 BOTTLE 6 NDC:37205-346-47 150 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076134 08/19/2003 Labeler - Cardinal Health (097537435) Registrant - Ranbaxy Pharmaceuticals Inc. (937890044) Establishment Name Address ID/FEI Business Operations Ohm Laboratories Inc. 051565745 manufacture(37205-346)