Children’s Loratadine Oral Solution Drug Facts

Active ingredient (in each 5 mL teaspoonful)

OTC - ACTIVE INGREDIENT SECTION

Loratadine 5 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat

Warnings

WARNINGS SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

do not use if carton is opened, or if printed neckband is broken or missing store between 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

edetate disodium, glycerin, maltitol, monobasic sodium phosphate, natural and artificial grape flavor, phosphoric acid, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or https://www.fda.gov/medwatch/report.htm DISTRIBUTED BY: ATLANTIC BIOLOGICALS MIAMI,FL 33179

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Children’s Claritin ® children’s loratadine oral solution loratadine oral solution USP, 5 mg/5 mL antihistamine allergy indoor & outdoor allergies non-drowsy * 24-hour relief of: • sneezing • runny nose • itchy, watery eyes • itchy throat or nose dye-free sugar-free ages 2 years and older *when taken as directed. See drug facts panel. grape flavor