Label: LORATADINEANTIHISTAMINE ANTIHISTAMINE- loratadine tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 49349-218-20 - Packager: REMEDYREPACK INC.
- This is a repackaged label.
- Source NDC Code(s): 45802-650
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated May 20, 2013
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
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WARNINGS
if you have ever had an allergic reaction to this product or any of its ingredients
liver or kidney disease. Your doctor should determine if you need a different dose.
do not take more than directed. Taking more than directed may cause drowsiness.
an allergic reaction to this product occurs. Seek medical help right away.
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away.
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- OTC - QUESTIONS
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
DRUG: Loratadineantihistamine antihistamine
GENERIC: Loratadine
DOSAGE: TABLET
ADMINSTRATION: ORAL
NDC: 49349-218-20
ACTIVE INGREDIENT(S):
- LORATADINE 10mg in 1
INACTIVE INGREDIENT(S):
- LACTOSE MONOHYDRATE
- POVIDONE
- MAGNESIUM STEARATE
- STARCH, CORN
COLOR: white
SHAPE: OVAL
SCORE: No score
SIZE: 8 mm
IMPRINT: L612
PACKAGING: 100 in 1 VIAL
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INGREDIENTS AND APPEARANCE
LORATADINEANTIHISTAMINE ANTIHISTAMINE
loratadine tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49349-218(NDC:45802-650) 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 LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) POVIDONE (UNII: FZ989GH94E) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color white Score no score Shape OVAL (TABLET) Size 8mm Flavor Imprint Code L612 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49349-218-20 100 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076301 05/20/2013 Labeler - REMEDYREPACK INC. (829572556)