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Simply Sleep

Dosage form
TABLET, FILM COATED
Labeler
Kenvue Brands LLC
Label updated
2025-06-02
Retrieved
2026-09-07
Active ingredients
DIPHENHYDRAMINE HYDROCHLORIDE
View original label and images on DailyMed ↗
Label information

Drug Facts

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep aid

Use

for relief of occasional sleeplessness

Warnings

Do not use

  • in children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin

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

Label information

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

  • avoid alcoholic drinks
  • drowsiness will occur
  • do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if

  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

Label information

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

Label information

Keep out of reach of children.

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions
adults and children 12 years and over take 2 caplets at bedtime if needed, or as directed by a doctor
children under 12 years do not use
Other information
  • each caplet contains: calcium 15 mg
  • store between 20-25°C (68-77°F). Avoid high humidity. Protect from light.
  • do not use if carton tape or foil inner seal imprinted with "SAFETY SEAL®" is broken or missing
Inactive ingredients

carnauba wax, croscarmellose sodium, dibasic calcium phosphate, FD&C Blue no. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Questions or comments?

call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

FROM THE MAKERS OF
TYLENOL ®PM

NDC 50580-843-12
Non-habit Forming

Simply
Sleep ®

Diphenhydramine HCl
Nighttime Sleep Aid
Does NOT Contain Pain Reliever
*Capsule-Shaped Tablets

Actual Size

100 Caplets*

[Image in the official label — see DailyMed source]

DailyMed Set ID: 37c606b0-04d5-49f0-886a-3ee2c9b0e9cc · Version 11
NDC: 50580-843