Adults and children 12 years and over: ▪take 1 tablet at bedtime if needed, or as directed by a doctor ▪if you feel drowsy in the morning, consult a doctor or pharmacist as you may require a lower dosage (25 mg) ▪do not take more than directed
Drug Facts
Diphenhydramine Hydrochloride 50 mg…………………………....Nighttime sleep aid
●if you are elderly, as this drug may cause excitation rather than sedation ●with any other product containing diphenhydramine, even one used on skin ●in children under 12 years of age
●have ▪a breathing problem such as emphysema or chronic bronchitis ▪glaucoma ▪difficulty urinating ●take sedatives or tranquilizers ●are pregnant or breastfeeding
avoid drinking alcohol
sleeplessness continues for more than 2 weeks. Sleeplessness may be a symptom of a serious underlying medical illness
In case of overdose, call a poison control centre or get medical help right away.
Adults and children 12 years and over: ▪take 1 tablet at bedtime if needed, or as directed by a doctor ▪if you feel drowsy in the morning, consult a doctor or pharmacist as you may require a lower dosage (25 mg) ▪do not take more than directed
▪ Store at 20° to 25°C
croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue no. 1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, mineral oil, silica, stearic acid, talc, titanium dioxide, triacetin
1-800-443-4908
Sleep•eze® MD
extra strength minis
DIPHENHYDRAMINE HYDROCHLORIDE TABLETS USP 50 mg
extra fort
DIPHÉNHYDRAMINE CHLORHYDRATE EN COMPRIMÉ USP 50 mg
nighttime sleep aid / la solution contre insomnie
16 coated tablets/ comprimes enrobes
DIN 02478757
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63029-926-16 | 2026-01-29 | C162847 | 48780-1 | 49896155-a95c-586f-e063-e6dba90add90 | SleepEze 50 mg Minis_Export only 63029-926-16 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63029-926-16 | SleepEze minis | 16 in 1 BOTTLE | TABLET | 16 | 2 | |
| 63029-926-16 | SleepEze minis | 1 in 1 CARTON | TABLET | 1 | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 63029-926 | 63029-926-16 |
Every source-derived ingredient row is available through these pages.
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 746c4560-b583-44a1-a6f3-594435d4244e | 16f9b5f4-c116-4f1d-9063-be3abb8ac9ee | 2024-01-18 | Warnings | 746c4560-b583-44a1-a6f3-594435d4244e 16f9b5f4-c116-4f1d-9063-be3abb8ac9ee |
Adverse event summaries are temporarily unavailable. Other product information remains available.