Label: CHILDRENS ALLERGY RELIEF- loratadine solution
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Contains inactivated NDC Code(s)
NDC Code(s): 11822-0098-3 - Packager: Rite Aid Corporation
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated October 18, 2012
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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
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
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
RITE
AID®
PHARMACYCompare to the
active ingredient in
Children's Claritin®*ORIGINAL
PRESCRIPTION
STRENGTHchildren's
allergy
reliefloratadine oral solution
5 mg/5 mL antihistaminefruit flavored oral solution
INDOOR &
OUTDOOR ALLERGIESNON-DROWSY†
DYE FREE
24 hour relief of:
sneezing & runny nose
itchy, watery eyes
itchy throat or nose2 years & older
4 FL OZ (120 mL)
† When taken as directed. See Drug Facts Panel.
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INGREDIENTS AND APPEARANCE
CHILDRENS ALLERGY RELIEF
loratadine solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-0098 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 FRUIT (peach) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-0098-3 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 - Rite Aid Corporation (014578892) Registrant - Taro Pharmacceuticals U.S.A., Inc (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceutical Industries Ltd. 600072078 MANUFACTURE(11822-0098)