Childrens Loratadine
FDA Label NDC 41520-085

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by American Sales Company for the product Childrens Loratadine (NDC 41520-085). 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 other, active ingredient (in each 5 ml), purpose, uses, otc - do not use, otc - ask doctor, otc - when using, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

DISTRIBUTED BY: American Sales Company
4201 Walden Avenue, Lancaster, NY 14086

Active Ingredient (In Each 5 Ml)

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

Otc - Do Not Use

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Otc - Ask Doctor

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

Otc - When Using

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.
  • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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

Directions

adults and children 6 years and over2 teaspoonfuls daily; do not take more than 2 teaspoonfuls in 24 hours
children 2 to under 6 years of age1 teaspoonful daily; do not take more than 1 teaspoonful in 24 hours
consumers with liver or kidney diseaseask a doctor

Other Information

  • safety sealed: do not use if imprinted safety seal is torn or missing
  • store between 2° and 25°C (36° and 77°F)

Inactive Ingredients

artificial grape flavor, citric acid monohydrate, glycerin, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sucrose.

Principal Display Panel - 118 Ml Bottle Carton

Compare to the
Active Ingredient
in Children's
Claritin®*

CAREONE®

24 HOUR/NON-DROWSY†
ALLERGY RELIEF

CHILDREN'S
LORATADINE

(Loratadine Oral Solution)
5 mg/5 mL Antihistamine

Dosage Cup
Enclosed

DYE FREE

GRAPE FLAVORED
SYRUP Ages two years and older

Relief of:
Sneezing, Runny Nose,
Itchy, Watery Eyes,
Itchy Throat or Nose

† When taken as directed.
See Drug Facts Panel.

4 FL OZ
(118 mL)

Principal Display Panel (118 mL Bottle Carton)

Principal Display Panel (118 mL Bottle Carton)

* Please review the disclaimer below.