Active Ingredients And Purpose
Active Ingredient (in each tablet)
Diphenhydramine Hydrochloride 25 mg
Purpose
Nighttime sleep-aid
Nighttime Sleep Aid
- Set ID
- 39f5b3bd-262d-4253-a4ee-8d286fbb475f
- 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 00:43:08
Key Label Information
Uses
Uses
• for the relief of occasional sleeplessness • reduces time to fall asleep if you have difficulty falling asleep
Warnings
Warnings
Directions And Dosage
Directions
take only one dose per day (24 hours) adults & children 12 years & over take 2 softgels at bedtime 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, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide
Questions or comments?
1-888-333-9792
Carton
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, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | IACT |
| SORBITAN | 6O92ICV9RU | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
Complete SPL Sections
Drug Facts
Active Ingredient (in each tablet)
Diphenhydramine Hydrochloride 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
Directions
take only one dose per day (24 hours) adults & children 12 years & over take 2 softgels 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#1, FD&C Red#40, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide
Questions or comments?
1-888-333-9792
SPL UNCLASSIFIED SECTION
Distributed By: Spirit Pharmaceuticals, LLC Ronkonkoma, NY 11779 Made in India
Carton
Source Document
Official SPL XML cached by FDA.report · DailyMed PDF
- XML object
- dailymed/39f5b3bd-262d-4253-a4ee-8d286fbb475f/29299135-c2e8-f499-e063-6294a90aff99.xml
- XML SHA-256
- 76e9c35110a77cf064f2bf5e5cab8d5e0811703a78aaaba0a82221b56dcf476f
- XML bytes
- 24003
Legacy File Index
| Folder | File | Date |
|---|---|---|
| otc | 29299135-c2e8-f499-e063-6294a90aff99.xml | 2024-12-15 |
| otc | 0c035fd4-cfb0-c132-e063-6394a90afeee.xml | 2023-12-09 |
| otc | ee8f3551-389f-6270-e053-2a95a90a60a9.xml | 2022-11-30 |
| otc | d43b8647-0d46-3a58-e053-2995a90af563.xml | 2021-12-29 |
| otc | Sleep aid.jpg | 2021-12-29 |