Label: CLARITIN- loratadine tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 52904-630-03, 52904-630-20, 52904-630-25 - Packager: Select Corporation
- This is a repackaged label.
- Source NDC Code(s): 11523-7160
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated June 7, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- 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?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 10 mg Pouch Blister Pack
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INGREDIENTS AND APPEARANCE
CLARITIN
loratadine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52904-630(NDC:11523-7160) 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) STARCH, CORN (UNII: O8232NY3SJ) magnesium stearate (UNII: 70097M6I30) Product Characteristics Color WHITE Score no score Shape ROUND Size 6mm Flavor Imprint Code 458;Claritin10 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52904-630-03 1 in 1 BLISTER PACK 12/15/2011 1 1 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:52904-630-20 20 in 1 CARTON 12/15/2011 2 1 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:52904-630-25 25 in 1 CARTON 12/15/2011 3 1 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019658 12/15/2011 Labeler - Select Corporation (053805599)