Childrens Loratadine Solution
FDA Label NDC 51672-2085

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Taro Pharmaceuticals U.s.a., Inc. for the product Childrens Loratadine (NDC 51672-2085). 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 teaspoonful), purpose, uses, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, 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:
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

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

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.

Otc - Stop Use

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

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. (1-800-222-1222)

Directions

  • use only with enclosed dosing cup
    • adults and children 6 years and over2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours
    children 2 to under 6 years of age1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours
    children under 2 years of ageask a doctor
    consumers with liver or kidney diseaseask a doctor

Other Information

  • do not use if carton is opened, or if imprinted safety seal is broken or missing
  • see bottom panel for expiration date
  • store between 20° to 25°C (68° to 77°F)

Inactive Ingredients

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

Questions?

Call 1-866-923-4914

Principal Display Panel - 120 Ml Bottle Carton

NDC xxxxx-xxxx-x

Compare to the
active ingredient
in Children's Claritin®*

GRAPE
FLAVOR

Original
Prescription Strength

Ages two years and older

Children's
Loratadine
Syrup
(Loratadine
Oral Solution)
5 mg/5 mL
Antihistamine

Grape Flavored Syrup

24 Hour Non-Drowsy†
Allergy Relief

Indoor &
Outdoor
Allergies

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

4 FL OZ (120 mL)

† When taken as directed. See Drug Facts Panel.

Principal Display Panel (120 mL Bottle Carton)

Principal Display Panel (120 mL Bottle Carton)

* Please review the disclaimer below.