Label: LORATADINE solution
- NDC Code(s): 37205-378-26
- Packager: Cardinal Health
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 5, 2019
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- 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
- Questions?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
LEADER®
NDC 37205-378-26
Compare to
Children's Claritin®
active ingredient†Original Prescription
StrengthNON-DROWSY*
Allergy
Relief
Loratadine Syrup
(Loratadine Oral Solution) 5 mg/5 mLAntihistamine
24 Hour
Relief of: Sneezing, Runny Nose,
Itchy, Watery Eyes • Itchy Throat or NoseFruit Flavor
*When taken as directed.
See Drug Facts Panel.Ages two years
and olderSATISFACTION
GUARANTEED4 FL OZ (120 mL)
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INGREDIENTS AND APPEARANCE
LORATADINE
loratadine solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-378 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 Score Shape Size Flavor PEACH Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37205-378-26 1 in 1 CARTON 08/20/2004 1 120 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076805 08/20/2004 Labeler - Cardinal Health (097537435) Establishment Name Address ID/FEI Business Operations Taro Pharmaceutical Industries Ltd. 600072078 MANUFACTURE(37205-378)