Childrens Loratadine Solution
FDA Label NDC 51672-2108

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 51672-2108). 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

  • each teaspoonful contains: sodium 5 mg
  • do not use if bottle wrap imprinted with "SEALED FOR SAFETY" is broken or missing.
  • store between 20° and 25°C (68° and 77°F)
  • see bottom panel for lot number and expiration date

Inactive Ingredients

bubble gum flavor, butylated hydroxyanisole, glycerin, maltitol solution, noncrystallizing sorbitol solution, phosphoric acid, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium phosphate monobasic dihydrate, sucralose powder

Questions?

Call 1-866-923-4914

Principal Display Panel - 120 Ml Bottle Carton

NDC 51672-2108-8

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

Children's
Loratadine
Oral Solution
USP, 5 mg/5 mL

(Antihistamine)
ALLERGY

Non-Drowsy†

Indoor & Outdoor Allergies

SUGAR FREE

24
Hour
Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

    • Ages 2 years and older

    Dosing Cup
    Enclosed

    Bubble Gum
    Flavor

    †When taken as directed.
    See Drug Facts Panel.

    4 FL OZ
    (120 mL)

* Please review the disclaimer below.