Active Ingredients And Purpose
Active ingredient (in each softgel)
Diphenhydramine HCL 50 mg
Purpose
Nighttime sleep-aid
NIGHTTIME SLEEP-AID
- Set ID
- 47b13a9e-baa8-4d46-aec5-d6a1ff7d5295
- 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 00:43:10
Key Label Information
Uses
Uses
for relief of occasional sleeplessness
Warnings
WARNINGS SECTION
Warnings
Directions And Dosage
Directions
adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor
Other Label Information
Inactive ingredients
FD&C Blue#1, gelatin, glycerin, polyethylene glycol-400, propylene glycol, sorbitol, titanium dioxide, water
Questions or comments?
1-888-333-9792
PRINCIPAL DISPLAY PANEL
Maximum Strength Nighttime Sleep-aid Diphenhydramine HCl 50 mg - Nighttime Sleep-Aid Helps reduce difficulty falling asleep Non-habit forming 8 Softgels
Products
- NIGHTTIME SLEEP AID
- DIPHENHYDRAMINE
NDC Codes
Ingredients
| Name | UNII | Kind |
|---|---|---|
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SORBITOL | 506T60A25R | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| WATER | 059QF0KO0R | IACT |
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
Complete SPL Sections
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each softgel)
Diphenhydramine HCL 50 mg
Purpose
Nighttime sleep-aid
Uses
for relief of occasional sleeplessness
WARNINGS SECTION
Warnings
Directions
adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor
Inactive ingredients
FD&C Blue#1, gelatin, glycerin, polyethylene glycol-400, propylene glycol, sorbitol, titanium dioxide, water
Questions or comments?
1-888-333-9792
PRINCIPAL DISPLAY PANEL
Maximum Strength Nighttime Sleep-aid Diphenhydramine HCl 50 mg - Nighttime Sleep-Aid Helps reduce difficulty falling asleep Non-habit forming 8 Softgels
Source Document
Official SPL XML cached by FDA.report ยท DailyMed PDF
- XML object
- dailymed/47b13a9e-baa8-4d46-aec5-d6a1ff7d5295/2929a2a2-e1aa-b109-e063-6394a90a76a3.xml
- XML SHA-256
- 5bfc36b2a670db6820edab64cbe659b3a6244e353acd46995d353b13660cfb3e
- XML bytes
- 23879
Legacy File Index
| Folder | File | Date |
|---|---|---|
| otc | 2929a2a2-e1aa-b109-e063-6394a90a76a3.xml | 2024-12-15 |
| otc | 0c020efe-316a-e904-e063-6294a90ad157.xml | 2023-12-09 |
| otc | ee8efe74-df7c-41b8-e053-2a95a90ac2bc.xml | 2022-11-30 |
| otc | cfd44659-ade4-dd15-e053-2995a90a2e70.xml | 2021-11-03 |
| otc | c10cbd51-f476-25ee-e053-2a95a90a293e.xml | 2021-04-29 |
| otc | Nighttime Sleep-Aid.jpg | 2021-04-29 |