Label: WAL-ITIN ALLERGY RELIEF- loratadine solution
-
Contains inactivated NDC Code(s)
NDC Code(s): 0363-2085-01, 0363-2085-08 - Packager: Walgreen Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 22, 2013
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
-
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
-
PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
Compare to Children's
Claritin†® active ingredientNDC 0363-2085-08
Walgreens
Ages 2 Years
& Older24 HOUR
ALLERGY RELIEFChildren's Non-Drowsy*
WAL-ITIN®Loratadine Oral Solution,
5mg/5mL AntihistamineAllergy Relief
Alcohol-FreeRelief of:
- Sneezing • Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
Dye-Free
Original Prescription Strength
GRAPE
FLAVORED SYRUP4 FL OZ (120 mL)
* When taken as directed. See Drug Facts Panel.
-
INGREDIENTS AND APPEARANCE
WAL-ITIN ALLERGY RELIEF
loratadine solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-2085 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:0363-2085-08 1 in 1 CARTON 1 120 mL in 1 BOTTLE 2 NDC:0363-2085-01 1 in 1 CARTON 2 240 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 - Walgreen Company (008965063) Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceutical Indutries Ltd. 600072078 MANUFACTURE(0363-2085)