Label: LORATADINE solution
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Contains inactivated NDC Code(s)
NDC Code(s): 54868-5580-0 - Packager: Physicians Total Care, Inc.
- This is a repackaged label.
- Source NDC Code(s): 51672-2073
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 23, 2011
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL)
- 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
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 4 FL OZ Label
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INGREDIENTS AND APPEARANCE
LORATADINE
loratadine solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-5580(NDC:51672-2073) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Loratadine (UNII: 7AJO3BO7QN) (Loratadine - UNII:7AJO3BO7QN) Loratadine 5 mg in 5 mL Inactive Ingredients Ingredient Name Strength citric acid monohydrate (UNII: 2968PHW8QP) glycerin (UNII: PDC6A3C0OX) propylene glycol (UNII: 6DC9Q167V3) water (UNII: 059QF0KO0R) sodium benzoate (UNII: OJ245FE5EU) sodium metabisulfite (UNII: 4VON5FNS3C) sucrose (UNII: C151H8M554) Product Characteristics Color YELLOW (Clear, colorless to light yellow) Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-5580-0 1 in 1 CARTON 1 120 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076805 04/28/2006 Labeler - Physicians Total Care, Inc. (194123980) Establishment Name Address ID/FEI Business Operations Physicians Total Care, Inc. 194123980 RELABEL