Label: LORATADINE tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 52959-740-10, 52959-740-14, 52959-740-15, 52959-740-20, view more52959-740-30 - Packager: H.J. Harkins Company, Inc.
- This is a repackaged label.
- Source NDC Code(s): 45802-650
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 24, 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
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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
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
Compare to Claritin® active ingredient
Loratadine Tablets, 10 mg
Antihistamine
24 Hour
Relief of:
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose
Indoor and Outdoor Allergies
Non-Drowsy*
*When taken as directed. See Drug Facts Panel.
Original Prescription Strength
Actual Size
Loratadine Tablets, 10 mg Carton
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INGREDIENTS AND APPEARANCE
LORATADINE
loratadine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52959-740(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) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color WHITE Score no score Shape OVAL Size 8mm Flavor Imprint Code L612 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52959-740-10 10 in 1 BOTTLE 2 NDC:52959-740-14 14 in 1 BOTTLE 3 NDC:52959-740-15 15 in 1 BOTTLE 4 NDC:52959-740-20 20 in 1 BOTTLE 5 NDC:52959-740-30 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076301 10/15/2008 Labeler - H.J. Harkins Company, Inc. (147681894) Establishment Name Address ID/FEI Business Operations Perrigo New York Inc 078846912 manufacture