Indications and uses
for relief of occasional sleeplessness
for relief of occasional sleeplessness
■ do not take more than directed (See overdose warning) ■ adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by doctor ■ children under 12 years: do not use
Diphenhydramine HCl 25mg
Night Time Sleep Aid
for relief of occasional sleeplessness
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 motorvehicle or operate machinery.
Stop use and ask a doctor if:
■ sleeplessness persist 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.
Overdose Warning:In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222).
■ do not take more than directed(See overdose warning)
■ adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by doctor
■ children under 12 years: do not use
■each caplet contains: calcium 23.52 mg
■store between 15-30°C (59-86°F).
■Avoid high humidity.
■ Protect from light.
Colloidal Silicon, Croscarmellose, Sodium, Dicalcium Phosphate, FD&C Blue#1, FD&C Blue#2, Lethicin, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol , Titanium Dioxide, Talc.
Call toll free 1-732-698-5070 Mon to Fri 9am – 5pm.
| 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 |
| 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 |
|---|---|---|---|---|---|
| 72090-020-10 | 2023-10-25 | C162847 | 48780-1 | d6a99b39-8fd3-a426-e053-dadaa90af4c2 | Nighttime Sleep Aid |
| 72090-020-10 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-8fd3-a426-e053-dadaa90af4c2 | Nighttime Sleep Aid |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72090-020-10 | Sleep Aid | 100 in 1 BOTTLE | TABLET | 100 | 6 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 72090-020 | 72090-020-10 |
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 |
|---|---|---|---|---|---|---|
| Sleep Aid | DIPHENHYDRAMINE HCL 25 MG | Pioneer Life Sciences, LLC | a9678fed-bda5-9513-e053-2995a90a25a1 | 2025-12-29 | Warnings | 72090-020-10 72090-020 72090002010 29ee011c-3b29-40a2-8b9b-ff1f5cb2fb69 a9678fed-bda5-9513-e053-2995a90a25a1 |
Adverse event summaries are temporarily unavailable. Other product information remains available.