Leader Childrens Allergy Relief Dye Free

SPL v3

SPL

SPL Set ID 198add5f-20b7-75b0-e063-6394a90a6bd4

Route

ORAL

Published

Effective Date 2024-10-21

Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (12.5 mg)

Inactive Ingredients

Carboxymethylcellulose Sodium Anhydrous Citric Acid Glycerin Water Saccharin Sodium Anhydrous Sodium Benzoate Sorbitol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-09-13

Description

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCl 12.5 mg

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

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)

Do Not Use

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

Other Information

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

Active Ingredient(s)

Diphenhydramine HCl 12.5 mg

Inactive Ingradients

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

Questions Or Comments?

(609) 860-2600

Principal Display Panel

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)

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.

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.

Structured Label Content

Use(s) (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

Purpose (PURPOSE)

Antihistamine

Warnings (WARNINGS)

Directions (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)

Do Not Use (DO NOT USE)

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

Other Information (OTHER INFORMATION)

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

Active Ingredient(s) (ACTIVE INGREDIENT(S))

Diphenhydramine HCl 12.5 mg

Inactive Ingradients (INACTIVE INGRADIENTS)

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

Questions Or Comments? (QUESTIONS OR COMMENTS?)

(609) 860-2600

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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)

When Using This Product (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. (KEEP OUT OF REACH OF CHILDREN.)

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

Ask A Doctor Before Use If the Child Has (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 (ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS)

taking sedatives or tranquilizers.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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 ", "PURPOSE": "Antihistamine", "WARNINGS": ".", "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)", "DO NOT USE": "to make a child sleepy with any other product containing diphenhydramine, even one used on skin", "OTHER INFORMATION": "each tsp contains: sodium 5 mg store at 68 o -77 o F", "ACTIVE INGREDIENT(S)": "Diphenhydramine HCl 12.5 mg", "INACTIVE INGRADIENTS": "carboxymethylcellulose sodium, citric acid, flavors, glycerin, purified water, saccharin sodium, sodium benzoate, sorbitol.", "QUESTIONS OR COMMENTS?": "(609) 860-2600", "PRINCIPAL DISPLAY PANEL": "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)", "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.", "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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:55.236374 · Updated: 2026-03-14T23:04:16.644897