Indications and uses
for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep
SLEEP AID
- Manufacturer
- Shield Pharmaceuticals Corp
- Effective date
- 2025-11-12
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:43:44
Label at a glance#
ProductSLEEP AID
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure11 sections
Dosage and administration
do not take more than directed take only one dose per day (24 hours) adults & children 12 yrs & over take 2 capsules at bedtime if needed or as directed by a doctor children under 12 years Do not use
Storage and handling
store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F) and high humidity Protect from light
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredients (in each softgel)
Diphenhydramine HCl 25 mg
Purpose
nighttime sleep-aid
Uses
- for the relief of occasional sleeplessness
- reduces time to fall asleep if you have difficulty falling asleep
WARNINGS SECTION
Warnings
Do not use
- for 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 asthma, emphysema, or chronic bronchitis
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
- heart disease
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you aretaking sedatives, tranquilizers or any other sleep aid
When using this product
- avoid alcoholic beverages and other drugs that cause drowsiness
- drowsiness will occur
- be careful when driving a motor vehicle or operating machinery
OTC - STOP USE SECTION
Stop use and ask a doctor ifsleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding,ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. 1(800)222-1222
Directions
- do not take more than directed
- take only one dose per day (24 hours)
| adults & children 12 yrs & over | take 2 capsules at bedtime if needed or as directed by a doctor |
| children under 12 years | Do not use |
Other information
- store at 20-25°C (68-77°F)
- avoid excessive heat above 40°C (104°F) and high humidity
- Protect from light
Inactive ingredients
FD&C blue no. 1, FD&C red no. 40, gelatin, glycerin, methylparaben*, polyethylene glycol-400, povidone, propylene glycol, propylparaben*, purified water, sorbitol sorbitan solution. *may contain this inactive ingredient
Questions or comments?
1-800-373-6981
OTC - QUESTIONS SECTION
Distributed by:
Shield Pharmaceuticals Corp.
Ronkonkoma, NY 11779
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Sleep Aid
Diphenhydramine HCl 25 mg
Fall Asleep Fast
- Non-Habit Forming
- Not for treating Pain, Cold or Flu
- Just for Sleep
Carton
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0611419406576 | GTIN-13: 0611419406576 EAN-13: 0611419406576 GTIN-12: 611419406576 UPC-A: 611419406576 GTIN storage (14 digits): 00611419406576 | Carton.jpg |
DailyMed Product Concepts#
| 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83059-0115-8 | SLEEP AID | 8 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 8 | 2 | |
| 83059-0115-8 | SLEEP AID | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | 2 |
Products#
Every source-derived product name is available through these pages.
- SLEEP AID
- DIPHENHYDRAMINE HYDROCHLORIDE
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- GELATIN
- GLYCERIN
- METHYLPARABEN
- POLYETHYLENE GLYCOL 400
- PROPYLENE GLYCOL
- POVIDONE
- PROPYLPARABEN
- SORBITOL SOLUTION
- SORBITAN
- WATER
- DIPHENHYDRAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 83059-0115 | 83059-0115-8 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| POVIDONE | FZ989GH94E | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| SORBITOL SOLUTION | 8KW3E207O2 | IACT |
| SORBITAN | 6O92ICV9RU | IACT |
| WATER | 059QF0KO0R | IACT |
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
Source Document#
openFDA label cross-check#
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 |
|---|---|---|---|---|---|---|
| 593f6e0c-c0fa-6951-e063-6394a90a777d | fb542d45-b941-4dea-be93-168b768eae4e | 2026-08-17 | Warnings | fb542d45-b941-4dea-be93-168b768eae4e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.