Leader Childrens Allergy Relief Solution
FDA Label NDC 70000-0474

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 Leader Childrens Allergy Relief (NDC 70000-0474). 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), purpose, uses, 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, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each 5 Ml)

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Uses

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • sneezing
  • itching of the nose or throat
  • runny nose
  • itchy, watery eyes

Do Not Use

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

Ask A Doctor Before Use If The Child Has

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

Ask A Doctor Or Pharmacist Before Use If The Child Is

taking sedatives or tranquilizers

When Using This Product

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

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

  • find right dose on chart below
  • mL = milliliter
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours

    • Age (yr)

    Dose (mL)

    children under 2 years

    do not use

    children 2 to 5 years

    do not use unless directed by a doctor

    children 6 to 11 years

    5 mL to 10 mL

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

Other Information

  • each 5 mL contains: sodium 15 mg
  • store at 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used.
  • do not use if printed neckband is broken or missing

Inactive Ingredients

anhydrous citric acid, D&C red #33, FD&C red #40, flavor, glycerin, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution

Questions Or Comments?

1-800-719-9260

Principal Display Panel

Children’s Allergy Relief

Diphenhydramine HCl 12.5 mg/5 mL Oral Solution

Antihistamine

Cherry Flavored Liquid

4-6 Hours/Dose

Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

Alcohol-Free

COMPARE TO CHILDREN’S BENADRYL® ALLERGY LIQUID

active ingredient

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8 FL OZ (237 mL)

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