Label: CHILDRENS NON-DROWSY 24-HOUR ALLERGY RELIEF- loratadine solution
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Contains inactivated NDC Code(s)
NDC Code(s): 21130-787-29 - Packager: Safeway Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 30, 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 21130-787-29
Compare to
Children's Claritin®
active ingredient†Children's
Non-Drowsy*24-Hour
Allergy ReliefLoratadine Oral Solution
5 mg/5 mL
AntihistamineRelieves:
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itching of Nose & Throat
Ages two years and older
*When taken as directed.
See Drug Facts panel.Dosage cup enclosed
Dye-FreeGrape Flavored
Alcohol Free4 FL OZ
(120 mL)SAFEWAY ™
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INGREDIENTS AND APPEARANCE
CHILDRENS NON-DROWSY 24-HOUR ALLERGY RELIEF
loratadine solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-787 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:21130-787-29 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 - Safeway Inc. (009137209) Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceutical Industries Ltd. 600072078 MANUFACTURE(21130-787)