Label: LORATADINE solution
- NDC Code(s): 70000-0125-1
- Packager: Cardinal Health, 110 dba LEADER
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated June 23, 2021
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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 - 118 mL Bottle Carton
LEADER™
Non-Drowsy†
Children's
AllergyLoratadine Oral Solution
USP, 5 mg/5 mLAntihistamine Allergy
Indoor & Outdoor AllergiesFruit Flavor
Dye Free24 Hour
Relief of:- Sneezing
- Runny Nose
- Itchy Watery Eyes
- Itchy Throat or Nose
Ages 2 Years
and OlderCOMPARE TO
CHILDREN'S
CLARITIN®
active ingredient*100% Money
Back Guarantee†When taken as directed. See Drug Facts Panel.
WARNING: Contains sodium metabisulfite, a sulfite that
may cause allergic-type reactions.4 FL OZ (118 mL)
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INGREDIENTS AND APPEARANCE
LORATADINE
loratadine solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0125 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 Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0125-1 1 in 1 CARTON 10/24/2016 1 118 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 08/20/2004 Labeler - Cardinal Health, 110 dba LEADER (063997360) Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)