Active Ingredients And Purpose
Active ingredients (in each softgel)
Diphenhydramine HCl 25 mg
Purpose
nighttime sleep-aid
NIGHTTIME SLEEP-AID
- Set ID
- 3f7f3feb-7a7d-4895-875e-c40be9bc5355
- Manufacturer
- SPIRIT PHARMACEUTICALS LLC
- Effective date
- 2024-12-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 00:43:09
Key Label Information
Uses
Uses
for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep
Warnings
WARNINGS SECTION
Warnings
Directions And Dosage
Directions
take only one dose per day (24 hours) - see Overdose warning adults & children 12 yrs & over One dose=TWO 25 mg softgels (50 mg) at bed time if needed or as directed by a doctor children under 12 years Do not use
Other Label Information
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#1, FD&C Red#40, gelatin, glycerin, polyethylene glycol-400, propylene glycol, sorbitol sorbitan, titanium dioxide
Questions or comments?
1-888-333-9792
PRINCIPAL DISPLAY PANEL
Nighttime sleep aid Diphenhydramine HCl 25 mg - Nighttime Sleep-Aid Helps reduce difficulty falling asleep Non-habit forming Not for treating pain, cold or flu 12 Softgels
Products
- NIGHTTIME SLEEP AID
- DIPHENHYDRAMINE
NDC Codes
Ingredients
| Name | UNII | Kind |
|---|---|---|
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SORBITOL | 506T60A25R | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
Complete SPL Sections
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
Directions
take only one dose per day (24 hours) - see Overdose warning adults & children 12 yrs & over One dose=TWO 25 mg softgels (50 mg) at bed time 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#1, FD&C Red#40, gelatin, glycerin, polyethylene glycol-400, propylene glycol, sorbitol sorbitan, titanium dioxide
Questions or comments?
1-888-333-9792
PRINCIPAL DISPLAY PANEL
Nighttime sleep aid Diphenhydramine HCl 25 mg - Nighttime Sleep-Aid Helps reduce difficulty falling asleep Non-habit forming Not for treating pain, cold or flu 12 Softgels
Source Document
Official SPL XML cached by FDA.report · DailyMed PDF
- XML object
- dailymed/3f7f3feb-7a7d-4895-875e-c40be9bc5355/2929b325-1003-92ea-e063-6294a90ad6fa.xml
- XML SHA-256
- ed4b6046d21f6c032d31cf349346b749c9f945e378f29df2948a6856a35f7871
- XML bytes
- 25561
Legacy File Index
| Folder | File | Date |
|---|---|---|
| otc | 2929b325-1003-92ea-e063-6294a90ad6fa.xml | 2024-12-15 |
| otc | 0bf31114-1aa2-2361-e063-6394a90a4750.xml | 2023-12-08 |
| otc | ee8efe74-df78-41b8-e053-2a95a90ac2bc.xml | 2022-11-30 |
| otc | cfe592ff-4747-15f1-e053-2995a90a964d.xml | 2021-11-04 |
| otc | Nighttime Sleep 12 ct.jpg | 2021-11-04 |
| otc | c0fbd152-5e62-505d-e053-2a95a90aa963.xml | 2021-04-28 |
| otc | Sleep-Aid.jpg | 2021-04-28 |