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 of age and over: - take 2 caplets at bedtime if needed, or as directed by a doctor children under 12 years of age: do not use
Diphenhydramine Hcl 25mg
Sleep-aid
for relief of occasional sleeplessness
Do not use -
for children under 12 years of age
with any other product containing diphenhydramine, even one used on skin
with other drugs that cause drowsiness
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 aretaking sedatives or tranquilizers.
drowsiness will occur
avoid alcoholic drinks
do not drive a motor vehicle or operating machinery
If pregnant or breast-feeding, ask a health professional before use.
Overdose Warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
do not take more than directed (see overdose warning)
adults and children 12 years of age and over: - take 2 caplets at bedtime if needed, or as directed by a doctor
children under 12 years of age: do not use
each caplet contains: calcium 15 mg
store between 20°-25°C (68°-77°F); avoid high humidity
protect from light
read all product information before using
dicalcium phosphate, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, opadry II
Call 1-732-698-5070 Monday through Friday 9AM–5PM EST or
www.pioneerlifesciences.com
sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
| 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 |
|---|---|---|---|---|---|
| 72090-020-26 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-9027-a426-e053-dadaa90af4c2 | aa2ce06b-89bc-b998-e053-2995a90a834a |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72090-020-26 | Sleep Aid | 1 in 1 CARTON | TABLET | 1 | 1 | |
| 72090-020-26 | Sleep Aid | 24 in 1 BOTTLE | TABLET | 24 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 72090-020 | 72090-020-26 |
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 |
| aa2ce06b-89bd-b998-e053-2995a90a834a | aa2ce06b-89bc-b998-e053-2995a90a834a | 2020-07-11 | Warnings | aa2ce06b-89bd-b998-e053-2995a90a834a aa2ce06b-89bc-b998-e053-2995a90a834a |
Adverse event summaries are temporarily unavailable. Other product information remains available.