Label: CHILDRENS LORATADINE SUGAR FREE- loratadine solution
- NDC Code(s): 51672-2108-1, 51672-2108-8
- Packager: Taro Pharmaceuticals U.S.A., Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated April 16, 2021
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL teaspoonful)
- Purpose
- Uses
-
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
-
PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
Compare to the
active ingredient
in Children's Claritin®*NDC 51672-2108-8
Children's
Loratadine
Oral Solution
USP, 5 mg/5 mL(Antihistamine) ALLERGY
Non-Drowsy†
Indoor & Outdoor Allergies
SUGAR FREE
24
Hour
Relief of:- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
Ages 2 years and older
Dosing Cup
EnclosedBubble Gum
Flavor†When taken as directed.
See Drug Facts Panel.4 FL OZ
(120 mL) -
INGREDIENTS AND APPEARANCE
CHILDRENS LORATADINE SUGAR FREE
loratadine solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51672-2108 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 butylated hydroxyanisole (UNII: REK4960K2U) glycerin (UNII: PDC6A3C0OX) polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A) sorbitol (UNII: 506T60A25R) phosphoric acid (UNII: E4GA8884NN) propylene glycol (UNII: 6DC9Q167V3) water (UNII: 059QF0KO0R) sodium benzoate (UNII: OJ245FE5EU) sodium phosphate, monobasic, dihydrate (UNII: 5QWK665956) Product Characteristics Color YELLOW (colorless to slightly yellow) Score Shape Size Flavor BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51672-2108-8 1 in 1 CARTON 12/08/2016 1 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:51672-2108-1 1 in 1 CARTON 12/08/2016 2 240 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 ANDA201865 12/08/2016 Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceutical Industries Ltd. 600072078 MANUFACTURE(51672-2108)