Label: CHILDRENS LORATADINE- loratadine solution
- NDC Code(s): 51672-2085-1, 51672-2085-4, 51672-2085-5, 51672-2085-8
- Packager: Taro Pharmaceuticals U.S.A., Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated January 24, 2020
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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
NDC xxxxx-xxxx-x
Compare to the
active ingredient
in Children's Claritin®*GRAPE
FLAVOROriginal
Prescription StrengthAges two years and older
Children's
Loratadine
Syrup
(Loratadine
Oral Solution)
5 mg/5 mL
AntihistamineGrape Flavored Syrup
24 Hour Non-Drowsy†
Allergy ReliefIndoor &
Outdoor
AllergiesRelief of:
Sneezing; Runny Nose,
Itchy, Watery Eyes,
Itchy Throat or Nose4 FL OZ (120 mL)
† When taken as directed. See Drug Facts Panel.
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INGREDIENTS AND APPEARANCE
CHILDRENS LORATADINE
loratadine solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51672-2085 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:51672-2085-8 1 in 1 CARTON 08/20/2004 1 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:51672-2085-4 1 in 1 CARTON 08/20/2004 2 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:51672-2085-5 1 in 1 CARTON 08/20/2004 3 180 mL in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:51672-2085-1 1 in 1 CARTON 08/20/2004 4 240 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 - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceutical Industries Ltd. 600072078 MANUFACTURE(51672-2085)