Childrens Allergy Relief Dye Free Liquid
FDA Label NDC 70000-0693

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 110, Llc. Dba Leader for the product Childrens Allergy Relief Dye Free (NDC 70000-0693). 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 the 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.

Label Section Quick Index

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 The 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 
  • use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device


    • AGE(yr)DOSE(mL or tsp) 
     children under 2 years  do not use
     children 2 to under 6 years  ask a doctor
     children 6 to under 12 years  1 to 2 tsp (5 mL to 10 mL)

Other Information

  • each tsp contains: sodium 5 mg 
  • store at 68o -77o F

Inactive Ingradients

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

Questions Or Comments?

(609) 860-2600

Principal Display Panel

LEADER TM

NDC 70000-0693-1

DYE-FREE

Children's Allergy Relief 

Diphenhydramine HCl

12.5mg /5 mL Oral Solution 

Antihistamine

Cherry

Flavored Liquid

4-6 hours/Dose

Relief of:

Sneezing 

Runny Nose 

itchy, water eyes

itchy Throat

or Nose

Alcohol -Free

100% Money Back Guarantee

8 FL OZ (236 mL)

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