Label: LORATADINE tablet, orally disintegrating
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Contains inactivated NDC Code(s)
NDC Code(s): 11673-513-69, 11673-527-31 - Packager: Target Corporation
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated October 5, 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
Compare to active ingredient in Alavert®*
24-hour allergy relief of: sneezing/
runny nose/itchy nose and throat
no water needed/tablets melt in your mouth
for adults and children 6 years and older
12 ORALLY DISINTEGRATING TABLETS
Distributed by Target Corporation
Original Prescription Strength
loratadine orally disintegrating tablets,
Compare to active ingredient in Claritin®Reditabs®*
24-hour allergy relief of: sneezing/runny
nose/itchy, watery eyes/itchy throat or nose
no water needed/tablets melt in your mouth
for adults and children 6 years and older
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INGREDIENTS AND APPEARANCE
LORATADINE
loratadine tablet, orally disintegratingProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-513 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:11673-513-69 1 in 1 CARTON 1 10 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077153 08/31/2007 LORATADINE
loratadine tablet, orally disintegratingProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-527 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:11673-527-31 1 in 1 CARTON 1 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 - Target Corporation (006961700) Registrant - Ranbaxy Pharmaceuticals Inc. (937890044) Establishment Name Address ID/FEI Business Operations Ohm Laboratories Inc. 051565745 manufacture(11673-513)
