Label: CHILDRENS LORATADINE- loratadine solution
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Contains inactivated NDC Code(s)
NDC Code(s): 41520-085-08 - Packager: American Sales Company
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 12, 2012
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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
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
Compare to the
Active Ingredient
in Children's
Claritin®*CAREONE®
24 HOUR/NON-DROWSY†
ALLERGY RELIEFCHILDREN'S
LORATADINE(Loratadine Oral Solution)
5 mg/5 mL AntihistamineDosage Cup
EnclosedDYE FREE
GRAPE FLAVORED
SYRUP Ages two years and olderRelief of:
Sneezing, Runny Nose,
Itchy, Watery Eyes,
Itchy Throat or Nose† When taken as directed.
See Drug Facts Panel.4 FL OZ
(118 mL) -
INGREDIENTS AND APPEARANCE
CHILDRENS LORATADINE
loratadine solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-085 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:41520-085-08 1 in 1 CARTON 1 118 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 - American Sales Company (809183973) Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceutical Indutries Ltd. 600072078 MANUFACTURE(41520-085)