Childrens Allergy Relief Solution
FDA Label NDC 51316-611

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs Woonsocket Prescription Center, Incorporated for the product Childrens Allergy Relief (NDC 51316-611). 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.

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.

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?

1-800-719-9260

Package/Label Principal Display Panel

CVS

Ages 2+ years

Grape Flavor

Children’s

ALLERGY RELIEF

Loratadine Oral Solution

5 mg/5 mL

Antihistamine

Compare to Children’s Claritin® active ingredient

24-Hour Relief of: Sneezing, Runny nose, Itchy & watery eyes, Itchy throat or nose

24 HR RELIEF

Non-Drowsy

Free of: Gluten, Parabens & Sugar

No Added Alcohol

Indoor & Outdoor Allergies

DYE FREE

8 FL OZ (240 mL)

dosing cup included

When taken as directed. See Drug Facts Panel.

Cvs-childrens-allergy-relief-carton-image.jpg (Cvs Childrens Allergy Relief Carton Image)

Cvs-childrens-allergy-relief-carton-image.jpg (Cvs Childrens Allergy Relief Carton Image)

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