Label: CHILDRENS WAL-ITIN- loratadine solution
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Contains inactivated NDC Code(s)
NDC Code(s): 0363-2092-01, 0363-2092-08 - Packager: Walgreen Company
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated March 24, 2014
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL teaspoonful)
- 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.
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Directions
- use only with enclosed dosing cup
adults and children 6 years and over 2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours children 2 to under 6 years of age 1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor - Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
Well at
WalgreensNDC 0363-2092-08
WALGREENS PHARMACIST RECOMMENDED‡
children's
Wal-itin®Loratadine Oral Solution
5 mg/5 mL / AntihistamineAllergy
- Alcohol free
- Sugar free
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Relief of runny nose, sneezing,
itchy throat or nose & itchy,
watery eyes - Non-drowsy*
- Ages 2 years & older
DYE &
SUGAR
FREEINDOOR &
OUTDOOR
ALLERGIES24
HOUR
RELIEF4 FL OZ (120 mL)
GRAPE
FLAVORCompare to Children's Claritin®
active ingredient‡‡*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.
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INGREDIENTS AND APPEARANCE
CHILDRENS WAL-ITIN
loratadine solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-2092 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 GLYCERIN (UNII: PDC6A3C0OX) SORBITOL (UNII: 506T60A25R) PHOSPHORIC ACID (UNII: E4GA8884NN) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM METABISULFITE (UNII: 4VON5FNS3C) SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956) 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:0363-2092-01 1 in 1 CARTON 1 240 mL in 1 BOTTLE 2 NDC:0363-2092-08 1 in 1 CARTON 2 120 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076805 02/27/2010 Labeler - Walgreen Company (008965063) Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceutical Industries Ltd. 600072078 MANUFACTURE(0363-2092) Establishment Name Address ID/FEI Business Operations Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(0363-2092)