Indications and uses
for the relief of occasional sleeplessness
NIGHTTIME SLEEP AID
- Manufacturer
- SPIRIT PHARMACEUTICALS LLC
- Effective date
- 2022-11-22
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:46:45
Label at a glance#
ProductNIGHTTIME SLEEP AID
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections
Dosage and administration
adults and children 12 years and over take 2 caplets at bedtime if needed, or as directed by a doctor children under 12 years do not use
Storage and handling
each caplet contains: calcium 23.52 mg store between 20-25°C(68-77°F). Avoid high humidity. Protect from light.
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredients (in each caplet)
Diphenhydramine HCl 25mg
Purpose
nighttime sleep-aid
Uses
for the relief of occasional sleeplessness
WARNINGS SECTION
Warnings
Do not use
- for children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
When using this product
- avoid alcoholic drinks
- drowsiness will occur
- do not drive a motor vehicle or operate machinery
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.
Overdose warning
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Directions
| adults and children 12 years and over | take 2 caplets at bedtime if needed, or as directed by a doctor |
| children under 12 years | do not use |
Other information
each caplet contains: calcium 23.52 mg
store between 20-25°C(68-77°F). Avoid high humidity. Protect from light.
Inactive ingredients
Colloidal siicon dioxide, croscarmellose sodium, dicalcium phosphate, FD&C Blue#1, FD&C Blue#2, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide
Questions or comments?
1-888-333-9792
PRINCIPAL DISPLAY PANEL
Compare to the active ingredient
in TYLENOL® SIMPLY SLEEP®*
NIGHTTIME
SLEEP AID
DIPHENHYDRAMINE HCl 25 mg
NON-HABIT FORMING
DOES NOT CONTAIN PAIN RELIEVER
Products#
Every source-derived product name is available through these pages.
- NIGHTTIME SLEEP AID
- DIPHENHYDRAMINE HYDROCHLORIDE
- SILICON DIOXIDE
- CROSCARMELLOSE SODIUM
- ANHYDROUS DIBASIC CALCIUM PHOSPHATE
- FD&C BLUE NO. 1
- FD&C BLUE NO. 2
- LECITHIN, SOYBEAN
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POLYVINYL ALCOHOL, UNSPECIFIED
- TALC
- TITANIUM DIOXIDE
- DIPHENHYDRAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68210-0230 | 68210-0230-2, 68210-0230-1 |
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 |
|---|---|---|---|---|---|---|
| 0c037778-ca37-30b3-e063-6294a90ac2cf | 5aac8e42-ae03-491f-90c0-19a110f1bc78 | 2023-12-08 | Warnings | 5aac8e42-ae03-491f-90c0-19a110f1bc78 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.