Label: CHILDRENS LORATADINE- loratadine solution
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Contains inactivated NDC Code(s)
NDC Code(s): 33261-908-01 - Packager: Aidarex Pharmaceuticals LLC
- This is a repackaged label.
- Source NDC Code(s): 51672-2085
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 28, 2012
If you are a consumer or patient please visit this version.
- 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
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PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
NDC 33261-908-01
Compare to the
active ingredient
in Claritin®*GRAPE
FLAVOROriginal
Prescription StrengthAges two years and older
Children's
Loratadine
Syrup
(Loratadine
Oral Solution)
5 mg/5 mL
AntihistamineGrape Flavored Syrup
24 hour
Non-Drowsy†
Allergy ReliefRelief of:
Sneezing; Runny Nose,
Itchy, Watery Eyes,
Itchy Throat or Nose4 FL OZ (120 mL)
† When taken as directed. See Drug Facts Panel.
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INGREDIENTS AND APPEARANCE
CHILDRENS LORATADINE
loratadine solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:33261-908(NDC:51672-2085) 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 (colorless to slightly yellow) Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:33261-908-01 5 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076805 08/20/2004 Labeler - Aidarex Pharmaceuticals LLC (801503249)