Children's Benadryl ®

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (12.5 mg)

Inactive Ingredients

Aluminum Oxide D&c Red No. 7 Dextrose, Unspecified Form Ethylcelluloses Fd&c Blue No. 1 Acacia Hydroxypropyl Cellulose, Unspecified Cellulose, Microcrystalline Sucralose Tartaric Acid Crospovidone D&c Red No. 30 Magnesium Stearate

Identifiers & Packaging

Pill Appearance

Imprint: B Shape: round Color: purple Size: 13 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2016-07-11

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 you are taking sedatives or tranquilizers

Section 53414-9

If pregnant or breast-feeding, ask a healthcare professional before use.

Directions

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

Age (yr)	Dose (chewable tablets)
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	1 to 2 chewable tablets (12.5 mg to 25 mg)
adults and children 12 years and over	2 to 4 chewable tablets (25 mg to 50 mg)

Do Not Use

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

Other Information

store between 20-25°C (68-77°F). Avoid high humidity. Protect from light.
do not use if carton or blister unit is opened or broken/unsealed
see bottom panel for lot number and expiration date

Inactive Ingredients

crospovidone, D&C red no. 30 aluminum lake, D&C red no. 7 calcium lake, dextrose excipient, ethylcellulose, FD&C blue no. 1 aluminum lake, flavors, gum arabic, hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, sucralose, sugar spheres, tartaric acid

Questions Or Comments?

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

Principal Display Panel

NDC 50580-232-01

Children's

Benadryl ^®

ALLERGY

Diphenhydramine HCl/antihistamine 12.5 mg chewable tablets

Chewables

4-6 Hours/Dose

RELIEF OF:

Runny Nose
Sneezing
Itchy, Watery Eyes
Itchy Throat or Nose

20

Chewable Tablets

Grape!

Flavored

Tablets

Actual Size

When Using This Product

marked drowsiness may occur
avoid alcohol drinks
alcohol, sedatives and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
excitability may occur, especially in children

Ask A Doctor Before Use If You Have

a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland

Active Ingredient (in Each Chewable Tablet)

Diphenhydramine HCl 12.5 mg

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 you are taking sedatives or tranquilizers

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a healthcare professional before use.

Purpose

Antihistamine

Directions

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

Age (yr)	Dose (chewable tablets)
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	1 to 2 chewable tablets (12.5 mg to 25 mg)
adults and children 12 years and over	2 to 4 chewable tablets (25 mg to 50 mg)

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)

store between 20-25°C (68-77°F). Avoid high humidity. Protect from light.
do not use if carton or blister unit is opened or broken/unsealed
see bottom panel for lot number and expiration date

Inactive Ingredients (Inactive ingredients)

crospovidone, D&C red no. 30 aluminum lake, D&C red no. 7 calcium lake, dextrose excipient, ethylcellulose, FD&C blue no. 1 aluminum lake, flavors, gum arabic, hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, sucralose, sugar spheres, tartaric acid

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 50580-232-01

Children's

Benadryl ^®

ALLERGY

Diphenhydramine HCl/antihistamine 12.5 mg chewable tablets

Chewables

4-6 Hours/Dose

RELIEF OF:

Runny Nose
Sneezing
Itchy, Watery Eyes
Itchy Throat or Nose

20

Chewable Tablets

Grape!

Flavored

Tablets

Actual Size

When Using This Product (When using this product)

marked drowsiness may occur
avoid alcohol drinks
alcohol, sedatives and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
excitability may occur, especially in children

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland

Active Ingredient (in Each Chewable Tablet) (Active ingredient (in each chewable tablet))

Diphenhydramine HCl 12.5 mg

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 you are taking sedatives or tranquilizers", "53414-9": "If pregnant or breast-feeding, ask a healthcare professional before use.", "Purpose": "Antihistamine", "Directions": "find right dose on chart below take every 4 to 6 hours, or as directed by a doctor do not take more than 6 times in 24 hours Age (yr) Dose (chewable tablets) 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 1 to 2 chewable tablets (12.5 mg to 25 mg) adults and children 12 years and over 2 to 4 chewable tablets (25 mg to 50 mg)", "Do not use": "to make a child sleepy with any other product containing diphenhydramine, even one used on skin", "Other information": "store between 20-25°C (68-77°F). Avoid high humidity. Protect from light. do not use if carton or blister unit is opened or broken/unsealed see bottom panel for lot number and expiration date", "Inactive ingredients": "crospovidone, D&C red no. 30 aluminum lake, D&C red no. 7 calcium lake, dextrose excipient, ethylcellulose, FD&C blue no. 1 aluminum lake, flavors, gum arabic, hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, sucralose, sugar spheres, tartaric acid", "Questions or comments?": "call 1-877-717-2824 or 215-273-8755 (collect)", "PRINCIPAL DISPLAY PANEL": "NDC 50580-232-01 Children's Benadryl ® ALLERGY Diphenhydramine HCl/antihistamine 12.5 mg chewable tablets Chewables 4-6 Hours/Dose RELIEF OF: Runny Nose Sneezing Itchy, Watery Eyes Itchy Throat or Nose 20 Chewable Tablets Grape! Flavored Tablets Actual Size", "When using this product": "marked drowsiness may occur avoid alcohol drinks alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children", "Ask a doctor before use if you have": "a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland", "Active ingredient (in each chewable tablet)": "Diphenhydramine HCl 12.5 mg"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information