Loratadine
FDA Label NDC 17856-6234

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Atlantic Biologicals Corps for the product Loratadine (NDC 17856-6234). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, uses, warnings, otc - ask doctor, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

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

Otc - Purpose

Purpose: Antihistamine

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

Warnings

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

Otc - Ask Doctor

liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor before use if you have

Otc - When Using

do not take more than directed. Taking more than directed may cause drowsiness. When using this product

Otc - Stop Use

an allergic reaction to this product occurs. Seek medical help right away. Stop use and ask a doctor if

Otc - Pregnancy Or Breast Feeding

, ask a health professional before use. If pregnant or breast-feeding

Otc - Keep Out Of Reach Of Children

. In case of overdose, get medical help or contact a Poison Control Center right away. Keep out of reach of children

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

Other Information

  • : sodium 1 mg Each teaspoonful contains
  • Safety Sealed. Do not use if imprinted seal around cap is broken or missing
  • Store between 20° to 25°C (68° to 77°F)

Inactive Ingredients

Butylated hydroxylanisole, citric acid, glycerin, grape flavor, propylene glycol, purified water, sodium benzoate, sucralose.

Questions

1-800-616-2471

Distributed by: Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48150 USA



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