Childrens Loratadine Oral Solution
FDA Label NDC 17856-6767

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 for the product Childrens Loratadine Oral (NDC 17856-6767). 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 active ingredient (in each 5 ml teaspoonful), purpose, uses, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each 5 Ml Teaspoonful)

Loratadine 5 mg

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

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).

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)

Inactive Ingredients

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?

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

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

* Please review the disclaimer below.