Children's Benadryl ®

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (12.5 mg)

Inactive Ingredients

Anhydrous Citric Acid D&c Red No. 33 Fd&c Red No. 40 Glycerin Ammonium Glycyrrhizate Poloxamer 407 Water Sodium Benzoate Sodium Chloride Sodium Citrate, Unspecified Form Sucrose

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

OTC MONOGRAPH DRUG Active Since 2008-07-01 Until 2022-12-28

Medication Information

Purpose

Antihistamine

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Section 50565-1

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)

Section 50568-5

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers

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.

Do Not Use

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

Other Information

each 5 mL contains: sodium 14 mg
store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used.
do not use if bottle wrap or foil inner seal imprinted with “Sealed For Your Safety” is broken or missing

Inactive Ingredients

anhydrous citric acid, D&C red no. 33, FD&C red no. 40, flavors, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose

Questions Or Comments?

call 1-877-717-2824 or 215-273-8755 (collect)

Principal Display Panel

NDC 50580-534-04

Children's

Benadryl ^®

ALLERGY

Diphenhydramine HCl/antihistamine

12.5 mg/5 mL oral solution

4-6 Hours/Dose

RELIEF OF:

Runny Nose
Sneezing
Itchy, Watery Eyes
Itchy Throat or Nose

Alcohol Free

Cherry!

Flavored

4 fl oz (118 mL)

When Using This Product

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

Active Ingredient (in Each 5 Ml)

Diphenhydramine HCl 12.5 mg

Ask A Doctor Before Use If the Child Has

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

Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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)

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers

Purpose

Antihistamine

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.

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 5 mL contains: sodium 14 mg
store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used.
do not use if bottle wrap or foil inner seal imprinted with “Sealed For Your Safety” is broken or missing

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, D&C red no. 33, FD&C red no. 40, flavors, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose

Questions Or Comments? (Questions or comments?)

call 1-877-717-2824 or 215-273-8755 (collect)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 50580-534-04

Children's

Benadryl ^®

ALLERGY

Diphenhydramine HCl/antihistamine

12.5 mg/5 mL oral solution

4-6 Hours/Dose

RELIEF OF:

Runny Nose
Sneezing
Itchy, Watery Eyes
Itchy Throat or Nose

Alcohol Free

Cherry!

Flavored

4 fl oz (118 mL)

When Using This Product (When using this product)

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

Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))

Diphenhydramine HCl 12.5 mg

Ask A Doctor Before Use If the Child Has (Ask a doctor before use if the child has)

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

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat", "42229-5": "Drug Facts", "50565-1": "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)", "50568-5": "Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers", "Purpose": "Antihistamine", "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.", "Do not use": "to make a child sleepy with any other product containing diphenhydramine, even one used on skin", "Other information": "each 5 mL contains: sodium 14 mg store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used. do not use if bottle wrap or foil inner seal imprinted with “Sealed For Your Safety” is broken or missing", "Inactive ingredients": "anhydrous citric acid, D&C red no. 33, FD&C red no. 40, flavors, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose", "Questions or comments?": "call 1-877-717-2824 or 215-273-8755 (collect)", "PRINCIPAL DISPLAY PANEL": "NDC 50580-534-04 Children's Benadryl ® ALLERGY Diphenhydramine HCl/antihistamine 12.5 mg/5 mL oral solution 4-6 Hours/Dose RELIEF OF: Runny Nose Sneezing Itchy, Watery Eyes Itchy Throat or Nose Alcohol Free Cherry! Flavored 4 fl oz (118 mL)", "When using this product": "marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children", "Active ingredient (in each 5 mL)": "Diphenhydramine HCl 12.5 mg", "Ask a doctor before use if the child has": "a breathing problem such as chronic bronchitis glaucoma a sodium-restricted diet"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information