Label: CHILDRENS ALLERGY RELIEF- loratadine solution
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Contains inactivated NDC Code(s)
NDC Code(s): 59779-093-01, 59779-093-04, 59779-093-08 - Packager: CVS Pharmacy
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated January 27, 2016
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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
CVS
Health™Compare to the active
ingredient in Children's Claritin®†Indoor & Outdoor
AllergiesNDC 59779-093-08
Children's
Allergy24
HOURLORATADINE
ORAL SOLUTION
USP, 5 mg/5 mL
(Antihistamine)
ALLERGYNon-Drowsy*
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24 hour relief of:
Sneezing; Runny nose; Itchy,
watery eyes; Itchy throat or nose - Sugar free & Dye free
- Ages 2 yrs & older
WARNING: Contains sodium metabisulfite,
a sulfite that may cause allergic-type reactions.*When taken as directed.
See Drug Facts Panel.Grape Flavor
Dosing Cup Enclosed4 FL OZ (120 mL)
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24 hour relief of:
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INGREDIENTS AND APPEARANCE
CHILDRENS ALLERGY RELIEF
loratadine solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-093 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:59779-093-04 1 in 1 CARTON 1 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:59779-093-01 1 in 1 CARTON 2 240 mL in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:59779-093-08 1 in 1 CARTON 3 120 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076805 02/27/2010 Labeler - CVS Pharmacy (062312574) Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceutical Industries Ltd. 600072078 MANUFACTURE(59779-093) Establishment Name Address ID/FEI Business Operations Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(59779-093)