Indications and uses
for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep
NIGHT TIME SLEEP-AID
- Manufacturer
- Advanced Rx LLC
- Effective date
- 2025-07-02
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:06:19
Label at a glance#
ProductNIGHT TIME SLEEP-AID
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure17 sections
Dosage and administration
• take only one dose (2 Caplets) per day (24 hours) adults & children 12 yrs & over 2 Caplets at bedtime if needed or as directed by a doctor children under 12 yrs do not use
Storage and handling
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) read all product information before using TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSIN
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredients (in each Caplet)
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
OTC - DO NOT USE SECTION
Do not use
- for children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
OTC - WHEN USING SECTION
When using this product
- avoid alcoholic beverages
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.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
• take only one dose (2 Caplets) per day (24 hours)
| adults & children 12 yrs & over | 2 Caplets at bedtime if needed or as directed by a doctor |
| children under 12 yrs | do not use |
Other information
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- read all product information before using
- TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSIN
Inactive ingredients
Microcrystalline Cellulose, Dicalcium Phosphate, Stearic Acid, Croscarmellose Sodium, Colloidal Silicon Dioxide, Hypromellose, Titanium Dioxide, Triacetin, FD&C Red No.40 Lake, FD&C Blue No.2 Aluminum Lake, Polysorbate.
Questions or comments
Call toll free 1-800-630-8895
Monday through Friday 9AM - 5PM EST
SPL UNCLASSIFIED SECTION
Distributed by:
Advanced Rx LLC
1942 NE 163rd St North Miami Beach,
FL 33162 U.S.A.
MADE IN THE USA
PRINCIPAL DISPLAY PANEL
NDC 80513-383-22
Compare to the active indredient in VICKS ®ZzzQuil ®NIGHTTIME SLEEP-AID*
NIGHT TIME SLEEP-AID
Diphenhydramine HCl 25 mg
220 CAPLETS
*This product is not manufactured or distributed by The The Procter & Gamble Company, owner of the registered trademark VICKS ®ZzzQuil ®NIGHTTIME SLEEP-AID
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 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80513-383-22 | NIGHT TIME SLEEP-AID | 220 in 1 BOTTLE | TABLET | 220 | 2 |
Products#
Every source-derived product name is available through these pages.
- NIGHT TIME SLEEP-AID
- Diphenhydramine HCl
- MICROCRYSTALLINE CELLULOSE
- ANHYDROUS DIBASIC CALCIUM PHOSPHATE
- STEARIC ACID
- CROSCARMELLOSE SODIUM
- SILICON DIOXIDE
- HYPROMELLOSE, UNSPECIFIED
- TITANIUM DIOXIDE
- TRIACETIN
- FD&C RED NO. 40 ALUMINUM LAKE
- FD&C BLUE NO. 2 ALUMINUM LAKE
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 80513-383 | 80513-383-22 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| NIGHT TIME SLEEP-AID | DIPHENHYDRAMINE HCL | Advanced Rx LLC | 07c69e63-deb1-4607-9f7f-1cf0cd05cc82 | 2025-07-02 | Warnings | 80513-383-22 80513-383 80513038322 38ec4df3-7635-3adf-e063-6394a90a0cec 07c69e63-deb1-4607-9f7f-1cf0cd05cc82 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.