Quality Choice Dye Free Cherry Childrens Allergy Relief Liquid
FDA Label NDC 83324-016

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association Inc. for the product Quality Choice Dye Free Cherry Childrens Allergy Relief (NDC 83324-016). 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(s), purpose, use(s), warnings, do not use, ask a doctor before use if child has, ask a doctor or pharmacist before use if the child is, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient(S)

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Use(S)

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

Warnings

.

Do Not Use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

Ask A Doctor Before Use If Child Has

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis 
  • a sodium-restricted diet

Ask A Doctor Or Pharmacist Before Use If The Child Is

taking sedatives or tranquilizers.

When Using This Product

  • alcohol, sedatives and tranquilizers may increase drowsiness
  • marked drowsiness may occur
  • excitability may occur, especially in children

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours

  • AGE(yr) 

    DOSE(mL or tsp) 
     children under 2 years do not use
     children under 6 years ask a doctor
     children 6 to 11 years1 to 2 tsp (5 mL to 10 mL)

Other Information

  • each tsp contains: sodium 5 mg
  • dosing cup provided
  • store at 68°-77°F

Inactive Ingredients

carboxymethylcellulose sodium, citric acid, flavors, glycerin, purified water , saccharin sodium, sodium benzoate, sorbitol.

Principal Display Panel

NDC 83324-016-04


QC® QUALITY CHOICE

 

*Compare to the Active Ingredient in Children's Benadryl®  Dye Free Allergy Liquid

 

Dye Free Children's  Allergy Relief 

 

Antihistamine


Diphenhydramine HCl

12.5 mg/5ml



 

Relieves:  Sneezing, Runny Nose, Itchy, Watery Eyes & Itchy Throat


CHERRY FLAVOR

 

4FL OZ(120 mL)

 

Qch-549-label-4oz.jpg (Qch 549 Label 4oz)

Qch-549-label-4oz.jpg (Qch 549 Label 4oz)

    

Qch-549-carton-4oz.jpg (Qch 549 Carton 4oz)

Qch-549-carton-4oz.jpg (Qch 549 Carton 4oz)

* Please review the disclaimer below.