Indications and uses
for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep
Nighttime SLEEP AID
- Manufacturer
- PuraCap Pharmaceutical LLC | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd
- Effective date
- 2019-12-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:02:11
Label at a glance#
ProductNighttime SLEEP AID
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections
Dosage and administration
take only one dose per day (24 hours) - see Overdose warning adults and children 12 yrs and over ONE dose = TWO 25 mg softgels (50 mg) at bed time if needed or as directed by a doctor
Storage and handling
store at room temperature 15°-30° C (59°-86° 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 ingredient (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
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 such as antihistamines and nighttime cold/flu products
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 are taking sedatives or 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 if sleeplessness 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.
Directions
- take only one dose per day (24 hours) - see Overdose warning
adults and children 12 yrs and over | ONE dose = TWO 25 mg softgels (50 mg) at bed time if needed or as directed by a doctor |
Other information
- store at room temperature 15°-30° C (59°-86° F)
- avoid excessive heat above 40° C (104° F) and high humidity
- protect from light
Inactive ingredients
FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special, and white edible ink
Questions or comments?
Call toll free: 1-855-215-8180
PRINCIPAL DISPLAY PANEL
PuraVation Nighttime SLEEP AID
Diphenhydramine HCl - 25 mg EACH
12 LIQUID-FILLED SOFTGELS
NDC 51013-181-02
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
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 |
| 6084a4f4-5437-c9a5-caec-5361ee075a59 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
| 90c5639a-61b0-88d6-ddcf-21888e94869a | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 51013-181-02 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-761a-d83d-e063-dadaa90ab31f | Nighttime SLEEP AID |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51013-181-02 | Nighttime SLEEP AID | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | 2 | |
| 51013-181-02 | Nighttime SLEEP AID | 12 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 12 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Nighttime SLEEP AID
- Diphenhydramine Hydrochloride
- DIPHENHYDRAMINE
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- GELATIN
- GLYCERIN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- WATER
- SORBITOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 51013-181 | 51013-181-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | IACT |
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 |
|---|---|---|---|---|---|---|
| dc48a41e-2ea8-4e30-b1a9-b7b64f8082bf | 310f58b6-a425-4513-9c0e-5c5439ede527 | 2019-12-20 | Warnings | dc48a41e-2ea8-4e30-b1a9-b7b64f8082bf 310f58b6-a425-4513-9c0e-5c5439ede527 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.