Label: ALLERGY RELIEF- loratadine tablet, orally disintegrating
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Contains inactivated NDC Code(s)
NDC Code(s): 37205-745-65 - Packager: Cardinal Health
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated July 24, 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
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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?
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PRINCIPAL DISPLAY PANEL
ORIGINAL PRESCRIPTION STRENGTH
Loratadine Orally Disintegrating Tablets, 10 mg
For Adults and Children six years and older!
runny nose; itchy throat or nose
*When taken as directed. See Drug Facts Panel.
30 ORALLY DISINTEGRATING TABLETS
Compare to Claritin® Reditabs® active ingredient†
This product is not manufactured or distributed by Schering-Plough Healthcare Products, Inc. CLARITIN® and REDITABS® are registered trademarks of Schering Corporation.
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INGREDIENTS AND APPEARANCE
ALLERGY RELIEF
loratadine tablet, orally disintegratingProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-745 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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) ASPARTAME (UNII: Z0H242BBR1) MANNITOL (UNII: 3OWL53L36A) SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white (white to off-white) Score no score Shape ROUND (flat faced beveled edge) Size 10mm Flavor STRAWBERRY, TUTTI FRUTTI, MINT Imprint Code RC17 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37205-745-65 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 - Cardinal Health (097537435) Registrant - Ranbaxy Pharmaceuticals Inc. (937890044) Establishment Name Address ID/FEI Business Operations Ohm Laboratories Inc. 051565745 manufacture(37205-745)