topcare childrens allergy relief

topcare childrens allergy relief is an FDA drug label for the active ingredient LORATADINE manufactured by Topco Associates LLC 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 20230620.

Generic: LORATADINE

Manufacturer: Topco Associates LLC

Product Type: HUMAN OTC DRUG

Route: ORAL

Dosage Form:

NDC: 36800-363

Application: ANDA210033

Effective: 20230620

Active Ingredients: Active ingredient (in each tablet) 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 • chew or crush tablets completely before swallowing adults and children 6 years and over chew 2 tablets daily; not more than 2 tablets in 24 hours children 2 to under 6 years of age chew 1 tablet daily; not more than 1 tablet in 24 hours children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Contraindications

Not available.

Warnings

Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients 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. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Adverse Reactions

Not available.

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