leader childrens allergy relief

leader childrens allergy relief is an FDA drug label for the active ingredient LORATADINE manufactured by Cardinal Health 110, LLC. dba Leader administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20210617.

Generic: LORATADINE

Manufacturer: Cardinal Health 110, LLC. dba Leader

Product Type: HUMAN OTC DRUG

Route: ORAL

Dosage Form:

NDC: 70000-0473

Application: ANDA075728

Effective: 20210617

Active Ingredients: Active ingredient (in each 5 mL teaspoonful) Loratadine 5 mg

Indications & Usage

Uses 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

Dosage & Administration

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 • 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)

Contraindications

Not available.

Warnings

Warnings

Adverse Reactions

Not available.

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