Active Ingredients And Purpose
Active Ingredient (in each softgel)
Diphenhydramine HCl 25 mg
Purpose
Nighttime sleep-aid
NIGHTTIME Sleep Aid Diphenhydramine HCl
- Set ID
- 11b7c200-b79f-4e35-9d53-00f021fa43b0
- Manufacturer
- Gobrands, Inc | Prodose, Inc
- Effective date
- 2024-12-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 00:45:17
Key Label Information
Uses
Uses
● for the relief of occasional sleeplessness ● reduces time to fall asleep if you have difficulty falling asleep
Directions And Dosage
Directions
take only one dose per day (24 hours) adults & children 12 years & 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 No. 1, FD&C Red No. 40, gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide.
Questions or comments?
1-888-333-9792
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
Products
- 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
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
Directions
take only one dose per day (24 hours) adults & children 12 years & 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 No. 1, FD&C Red No. 40, gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide.
Questions or comments?
1-888-333-9792
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
Source Document
Official SPL XML cached by FDA.report · DailyMed PDF
- XML object
- dailymed/11b7c200-b79f-4e35-9d53-00f021fa43b0/29ba17fa-1186-3c2b-e063-6394a90a0d4c.xml
- XML SHA-256
- 06fce1dbdd43e2545bdfac8a1f94a344a1f0b5e451a666dae4732e015dd0b7d1
- XML bytes
- 22668
Legacy File Index
| Folder | File | Date |
|---|---|---|
| otc | 29ba17fa-1186-3c2b-e063-6394a90a0d4c.xml | 2024-12-22 |
| otc | 0c04ef09-109f-4c9f-e063-6394a90a3bbf.xml | 2023-12-09 |
| otc | ee17d291-2a44-3ba7-e053-2a95a90a4ffb.xml | 2022-11-24 |
| otc | df288f85-1cdf-5fd2-e053-2a95a90a1b08.xml | 2022-05-17 |
| otc | Slip Aid carton 24 ct.jpg | 2022-05-17 |