Benadryl ®

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (25 mg)

Inactive Ingredients

Carnauba Wax Croscarmellose Sodium D&c Red No. 27 Aluminum Lake Dibasic Calcium Phosphate Dihydrate Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polysorbate 80 Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: B;WL;25 Shape: oval Color: pink Size: 11 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2008-09-01

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
temporarily relieves these symptoms due to the common cold:
- runny nose
- sneezing

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 health professional before use.

Directions

take every 4 to 6 hours, or as directed by a doctor
do not take more than 6 times in 24 hours

adults and children 12 years and over	1 to 2 tablets
children 6 to under 12 years	1 tablet
children under 6 years	do not use

Do Not Use

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

Other Information

each tablet contains: calcium 15 mg
store between 20-25°C (68-77°F). Protect from light.
do not use if blister unit is torn or broken

Inactive Ingredients

carnauba wax, croscarmellose sodium, D&C red no. 27 aluminum lake, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Questions Or Comments?

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

Principal Display Panel

NDC 50580-226-12

Benadryl ^®

ALLERGY

Diphenhydramine HCl 25mg | Antihistamine

✓ Sneezing

✓ Runny Nose

✓ Itchy, Watery Eyes

✓ Itchy Throat

ULTRATABS ^®*

*small tablet size

actual size

12 TABLETS

When Using This Product

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

Active Ingredient (in Each Tablet)

Diphenhydramine HCl 25 mg

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

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
temporarily relieves these symptoms due to the common cold:
- runny nose
- sneezing

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 health professional before use.

Purpose

Antihistamine

Directions

take every 4 to 6 hours, or as directed by a doctor
do not take more than 6 times in 24 hours

adults and children 12 years and over	1 to 2 tablets
children 6 to under 12 years	1 tablet
children under 6 years	do not use

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 tablet contains: calcium 15 mg
store between 20-25°C (68-77°F). Protect from light.
do not use if blister unit is torn or broken

Inactive Ingredients (Inactive ingredients)

carnauba wax, croscarmellose sodium, D&C red no. 27 aluminum lake, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 50580-226-12

Benadryl ^®

ALLERGY

Diphenhydramine HCl 25mg | Antihistamine

✓ Sneezing

✓ Runny Nose

✓ Itchy, Watery Eyes

✓ Itchy Throat

ULTRATABS ^®*

*small tablet size

actual size

12 TABLETS

When Using This Product (When using this product)

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

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

Diphenhydramine HCl 25 mg

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

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 temporarily relieves these symptoms due to the common cold: runny nose sneezing", "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 health professional before use.", "Purpose": "Antihistamine", "Directions": "take every 4 to 6 hours, or as directed by a doctor do not take more than 6 times in 24 hours adults and children 12 years and over 1 to 2 tablets children 6 to under 12 years 1 tablet children under 6 years do not use", "Do not use": "to make a child sleepy with any other product containing diphenhydramine, even one used on skin", "Other information": "each tablet contains: calcium 15 mg store between 20-25°C (68-77°F). Protect from light. do not use if blister unit is torn or broken", "Inactive ingredients": "carnauba wax, croscarmellose sodium, D&C red no. 27 aluminum lake, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide", "Questions or comments?": "call 1-877-717-2824 (toll-free) or 215-273-8755 (collect)", "PRINCIPAL DISPLAY PANEL": "NDC 50580-226-12 Benadryl ® ALLERGY Diphenhydramine HCl 25mg | Antihistamine ✓ Sneezing ✓ Runny Nose ✓ Itchy, Watery Eyes ✓ Itchy Throat ULTRATABS ®* *small tablet size actual size 12 TABLETS", "When using this product": "marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children", "Active ingredient (in each tablet)": "Diphenhydramine HCl 25 mg", "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"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information