Label: LORATADINE tablet
- NDC Code(s): 62207-787-49, 62207-787-88
- Packager: Granules India Limited
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 13, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- ASK A DOCTOR BEFORE USE IF
- WHEN USING THIS PRODUCT
- STOP USE AND ASK DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
LORATADINE
loratadine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62207-787 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 MAGNESIUM STEARATE (UNII: 70097M6I30) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color white (White to off white) Score no score Shape ROUND Size 6mm Flavor Imprint Code G;10 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62207-787-49 1000 in 1 BOTTLE; Type 0: Not a Combination Product 01/08/2020 2 NDC:62207-787-88 5 in 1 BOX 03/16/2020 2 20000 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210722 01/08/2020 Labeler - Granules India Limited (915000087) Establishment Name Address ID/FEI Business Operations Granules India Limited 918609236 analysis(62207-787) , manufacture(62207-787)