Loratadine

Loratadine is an FDA drug label for the active ingredient LORATADINE manufactured by A-S Medication Solutions 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 20231209.

Generic: LORATADINE

Manufacturer: A-S Medication Solutions

Product Type: HUMAN OTC DRUG

Route: ORAL

Dosage Form:

NDC: 50090-1454

Application: ANDA077421

Effective: 20231209

Active Ingredients: Active Ingredient: Loratadine 5 mg (in each 5 mL(teaspoonful)(TSP))Active Ingredient: Loratadine 5 mg (in each 5 mL(teaspoonful(tsp)))

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 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

Contraindications

Not available.

Warnings

Warnings Do not use if you have ever had allergic reaction to this product or any of it's 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.

Adverse Reactions

Not available.

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