leader childrens allergy relief

Manufacturer
Cardinal Health 110, LLC. dba Leader
Effective date
2025-07-22
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:08:17

Key Label Information

Active Ingredients And Purpose

Active ingredient (in each 5 mL)

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Uses

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

Warnings

Warnings

Directions And Dosage

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 Label Information

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 100 % Money Back Guarantee 8 FL OZ (237 mL)

Label Images

379 E9 childrens allergy relief image
379 E9 childrens allergy relief image

Products

NDC Codes

Ingredients

Complete SPL Sections

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 12.5 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

• 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

Warnings

WARNINGS SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

STORAGE AND HANDLING SECTION

• 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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.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 100 % Money Back Guarantee 8 FL OZ (237 mL)

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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28161

Legacy File Index

FolderFileDate
otc8166578a-7f50-40f6-b681-c965f72288ba.xml2025-07-24
otc0d2858c7-6e17-4864-8198-6c580bba8e72.xml2024-07-10
otc85e232bd-910c-4d4a-b055-4c7442cdd381.xml2021-06-18
otc379 E9 childrens allergy relief image.jpg2020-01-08
otc63e356f0-5c7e-402b-973b-0900e074f9d4.xml2020-01-08
otc40d697b7-dc59-4d24-8d46-db635e01b9d5.xml2019-12-10