Label: LORATADINE ODT- loratadine tablet, orally disintegrating
-
Contains inactivated NDC Code(s)
NDC Code(s): 21130-527-31, 21130-527-69 - Packager: Safeway Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 25, 2012
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
-
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
- Phenylketonurics: Contains Phenylalanine 0.6 mg Per Tablet.
- TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
- store between 20° to 25° C (68° to 77° F). Protect from excessive moisture.
- keep in a dry place.
- use tablet immediately after opening individual blister.
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
LORATADINE ODT
loratadine tablet, orally disintegratingProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-527 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 ASPARTAME (UNII: Z0H242BBR1) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) Product Characteristics Color white (White to Off-White) Score no score Shape ROUND (flat faced beveled edge) Size 10mm Flavor FRUIT Imprint Code RC17 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-527-69 10 in 1 BLISTER PACK 2 NDC:21130-527-31 30 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077153 08/31/2007 Labeler - Safeway Inc. (009137209) Registrant - Ranbaxy Pharmaceuticals Inc. (937890044) Establishment Name Address ID/FEI Business Operations Ohm Laboratories Inc. 051565745 manufacture(21130-527)