Label: CHILDRENS ALLERGY- loratadine solution
- NDC Code(s): 49035-538-08, 49035-538-09
- Packager: Wal-Mart Stores Inc
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated April 15, 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 - 120 mL Bottle Carton
NDC 49035-538-09
equate™
Compare to
Children's
Claritin®
active
ingredient*children*s
ALLERGYLoratadine Oral
Solution USP,
5mg/5mLAntihistamine
Non-Drowsy†
24
HOURSSugar-Free
Dye-FreeAGES 2 YEARS AND OLDER
24 Hour
Relief of:- Sneezing
- Runny nose
- Itchy, watery eyes
- Itchy throat
or nose
Indoor & Outdoor
AllergiesBubble Gum Flavor
4 FL OZ (120mL)
Dosing Cup
Enclosed†When taken as directed. See Drug Facts Panel.
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INGREDIENTS AND APPEARANCE
CHILDRENS ALLERGY
loratadine solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-538 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) maltitol (UNII: D65DG142WK) sorbitol (UNII: 506T60A25R) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) phosphoric acid (UNII: E4GA8884NN) propylene glycol (UNII: 6DC9Q167V3) water (UNII: 059QF0KO0R) sodium benzoate (UNII: OJ245FE5EU) SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956) SUCRALOSE (UNII: 96K6UQ3ZD4) 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:49035-538-08 1 in 1 CARTON 06/21/2019 1 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:49035-538-09 1 in 1 CARTON 03/07/2021 2 120 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 ANDA201865 12/08/2016 Labeler - Wal-Mart Stores Inc (051957769)