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

Active Ingredient

Diphenhydramine HCl 25 mg

Uses

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

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

Other Information

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

Description

Drug Facts

Principal Display Panel

NDC 71205-521-06

Benadryl^®

ALLERGY

Diphenhydramine HCl 25mg | Antihistamine

✓ Sneezing

✓ Runny Nose

✓ Itchy, Watery Eyes

✓ Itchy Throat

ULTRATABS^®*

*small tablet size

actual size

6 TABLETS

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.

Do Not Use

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

Questions Or Comments?

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

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

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

Active Ingredient (Active ingredient (in each tablet))

Diphenhydramine HCl 25 mg

Uses

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

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

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 carton is opened or if blister unit is 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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 71205-521-06

Benadryl^®

ALLERGY

Diphenhydramine HCl 25mg | Antihistamine

✓ Sneezing

✓ Runny Nose

✓ Itchy, Watery Eyes

✓ Itchy Throat

ULTRATABS^®*

*small tablet size

actual size

6 TABLETS

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.

Do Not Use (Do not use)

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

Questions Or Comments? (Questions or comments?)

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

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

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

[{"name": "Diphenhydramine", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "Carnauba Wax", "unii": "R12CBM0EIZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Croscarmellose Sodium", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C red no. 27 aluminum lake", "unii": "ZK64F7XSTX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Dibasic Calcium Phosphate Dihydrate", "unii": "O7TSZ97GEP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Hypromellose, Unspecified", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Magnesium Stearate", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Microcrystalline Cellulose", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Polyethylene Glycol, Unspecified", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Polysorbate 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Titanium Dioxide", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: o runny nose o sneezing o itchy, watery eyes o itching of the nose or throat • temporarily relieves these symptoms due to the common cold: o runny nose o 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 carton is opened or if blister unit is 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 71205-521-06 Benadryl ® ALLERGY Diphenhydramine HCl 25mg | Antihistamine ✓ Sneezing ✓ Runny Nose ✓ Itchy, Watery Eyes ✓ Itchy Throat ULTRATABS ®* *small tablet size actual size 6 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