Childrens Loratadine
FDA Label NDC 68016-131

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pharmacy Value Alliance Llc for the product Childrens Loratadine (NDC 68016-131). 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:
Pharmacy Value Alliance, LLC
407 East Lancaster Avenue
Wayne, PA 19087

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 bottle wrap imprinted with "SEALED FOR SAFETY" is broken or missing.
  • see bottom panel for lot number and expiration date
  • store between 20° and 25°C (68° and 77°F)

Inactive Ingredients

butylated hydroxyanisole, glycerin, grape flavor, maltitol solution, masking agent, phosphoric acid, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium phosphate monobasic dihydrate, sorbitol solution, sucralose powder.

Questions?

Call 1-866-923-4914

Principal Display Panel - 120 Ml Bottle Carton

COMPARE TO THE
ACTIVE INGREDIENT IN
CHILDREN'S CLARITIN®*

Premier
Value ®

Ages
2 years
and older

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

Antihistamine
Allergy

SUGAR FREE GRAPE flavor

INDOOR & OUTDOOR ALLERGIES

Non-Drowsy†

24 Hour Relief of:

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

    • †When taken
    as directed.
    See Drug
    Facts Panel.

    4 FL OZ
    (120 mL)

    INDEPENDENTLY TESTED
    PV
    SATISFACTION GUARANTEED

    Principal Display Panel (120 mL Bottle Carton)

    Principal Display Panel (120 mL Bottle Carton)

* Please review the disclaimer below.