Simply Sleep
diphenhydramine hydrochloride · Tablet, Film Coated · Oral
Active ingredient
Active ingredient (in each caplet) Diphenhydramine HCl 25 mg
Purpose
Purpose Nighttime sleep aid
Uses
Use for relief of occasional sleeplessness
Warnings
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 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. If pregnant or breast-feeding, ask a health professional before use. 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)
Do not use
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
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
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
When using this product
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
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.
Pregnancy or breast-feeding
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children
Keep out of reach of children.
Directions
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
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
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?
Questions or comments? call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)
Label text from the FDA structured product label by Kenvue Brands LLC (revised Jun 2, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Diphenhydramine Hydrochloride in 1 product
Simply Sleep NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50580-843 | Diphenhydramine Hydrochloride 25 mg/1 Tablet, Film Coated | Kenvue Brands LLC | OTC MONOGRAPH DRUG |
Frequently asked questions
What is Simply Sleep used for?
Use for relief of occasional sleeplessness
Who makes Simply Sleep?
Simply Sleep is listed by 1 labeler in the FDA NDC directory, including Kenvue Brands LLC.