Benadryl ®

Benadryl ®
SPL v4
SPL
SPL Set ID dd0a8069-18d8-5696-e053-2995a90a2f22
Route
ORAL
Published
Effective Date 2022-04-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (50 mg)
Inactive Ingredients
Carnauba Wax Croscarmellose Sodium Dibasic Calcium Phosphate Dihydrate Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polysorbate 80 Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: B;50MG Shape: oval Color: white Size: 14 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-07-05
Description

Drug Facts

Purpose

Antihistamine

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 tablet
children under 12 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 35 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, 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

NEW NDC 50580-533-24

Benadryl ®

ALLERGY

EXTRA STRENGTH

Diphenhydramine HCl 50mg | Antihistamine

✓ Sneezing ✓ Runny Nose



✓ Itchy, Watery Eyes ✓ Itchy Throat

actual size

24 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 50 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 tablet
children under 12 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 35 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, 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)

NEW NDC 50580-533-24

Benadryl ®

ALLERGY

EXTRA STRENGTH

Diphenhydramine HCl 50mg | Antihistamine

✓ Sneezing ✓ Runny Nose



✓ Itchy, Watery Eyes ✓ Itchy Throat

actual size

24 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 50 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

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:11.959091 · Updated: 2026-03-14T23:04:46.577979