Childrens Allergy Relief
FDA Label NDC 49035-183

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores Inc for the product Childrens Allergy Relief (NDC 49035-183). 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:
Wal-Mart Stores, Inc.,
Bentonville, AR 72716.

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.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health care 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 over: 2 teaspoonfuls daily; do not take more than 2 teaspoonfuls in 24 hours
  • children 2 to under 6 years of age: 1 teaspoonful daily; do not take more than 1 teaspoonful in 24 hours
  • consumers with liver or kidney disease: ask a doctor

Other Information

  • 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

Questions?

Call: 1-888-287-1915

Principal Display Panel - 120 Ml Bottle Carton

NDC 49035-183-80

equate®

Compare
to Children's
Claritin®
Active
Ingredient*

Ages 2+
Children's
Allergy Relief
Loratadine Oral Solution
5 mg/5 mL Antihistamine

24 Hour
Non-Drowsy**

Relieves:

  • Sneezing
  • Runny nose
  • Itchy, watery
    eyes
  • Itchy throat
    or nose

    • Original
    Prescription Strength
    Dye Free

    Grape Flavor

    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.