Label: SUNMARK CHILDRENS LORATADINE- loratadine solution
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Contains inactivated NDC Code(s)
NDC Code(s): 49348-849-34 - Packager: McKesson
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 12, 2012
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- 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
sunmark®
COMPARE TO
CHILDREN'S CLARITIN®
ACTIVE INGREDIENT*NDC 49348 849-34
24 HOUR
ALLERGY RELIEFchildren's
loratadine
syrup(Loratadine Oral Solution)
5 mg/5 mL AntihistamineRelief of
sneezing, runny nose
itchy, watery eyes
itchy throat or noseDye Free
Non-drowsy†
Ages two years & olderGRAPE FLAVOR
4 FL OZ (120 mL)
† When taken as directed. See Drug Facts Panel.
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INGREDIENTS AND APPEARANCE
SUNMARK CHILDRENS LORATADINE
loratadine solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-849 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:49348-849-34 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 08/20/2004 Labeler - McKesson (177667227) Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceutical Industries Ltd. 600072078 MANUFACTURE(49348-849)