Indications and uses
for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep
Nighttime Sleepaid
- Manufacturer
- Kareway Product, Inc. | DongKoo Pharm. Ind. Co., Ltd.
- Effective date
- 2014-10-22
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:40:38
Label at a glance#
ProductNighttime Sleepaid
Active ingredientDiphenhydramine Hydrochloride
Label structure10 sections
Dosage and administration
take only one dose per day (24 hours) - see Overdose warning adults & children 12 yrs & over One dose = TWO 25 mg Softgels (50 mg) at bed time if needed or as directed by a doctor
Storage and handling
store at 20-25° C (68-77° F) avoid excessive heat above 40° C (104° F) and high humidity Protect from light
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredients (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
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.
- with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
- a breathing problem such as asthma, emphysema, or chronic bronchitis
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
- heart disease
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep-aid
OTC - WHEN USING SECTION
When using this product
- avoid alcoholic beverages and other drugs that cause drowsiness
- drowsiness will occur
- be careful when driving a motor vehicle or operating machinery
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. Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.(1-800-222-1222)
Directions
- take only one dose per day (24 hours) - see Overdose warning
| adults & children 12 yrs & over | One dose = TWO 25 mg Softgels (50 mg) at bed time if needed or as directed by a doctor |
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 Rd No. 40, gelatin, glycerin, polyethylene glycol 400, partially hydrated sorbitol liquid, purified water
SPL UNCLASSIFIED SECTION
Exclusively distributed by:
Kareway Product, Inc.
2550 S. Dominguez Hills Dr.
Compton, CA 90220
Made in Korea
PRINCIPAL DISPLAY PANEL - 12 Capsule Carton
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 67510-0557-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-bdb8-f424-e053-dadaa90a57ce | Pure-Aid NIGHTTIME SLEEP-AID |
| 67510-0557-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-bdb8-f424-e053-dadaa90a57ce | Pure-Aid NIGHTTIME SLEEP-AID |
| 67510-0557-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-bdb8-f424-e053-dadaa90a57ce | Pure-Aid NIGHTTIME SLEEP-AID |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67510-0557-1 | Nighttime Sleepaid | 12 in 1 CARTON | CAPSULE, GELATIN COATED | 12 | 1 | |
| 67510-0557-1 | Nighttime Sleepaid | 2 in 1 BLISTER PACK | CAPSULE, GELATIN COATED | 2 | 1 | |
| 67510-0557-2 | Nighttime Sleepaid | 24 in 1 CARTON | CAPSULE, GELATIN COATED | 24 | 1 | |
| 67510-0557-2 | Nighttime Sleepaid | 2 in 1 BLISTER PACK | CAPSULE, GELATIN COATED | 2 | 1 | |
| 67510-0557-3 | Nighttime Sleepaid | 2 in 1 BLISTER PACK | CAPSULE, GELATIN COATED | 2 | 1 | |
| 67510-0557-3 | Nighttime Sleepaid | 36 in 1 CARTON | CAPSULE, GELATIN COATED | 36 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 67510-0557 | NIGHTTIME SLEEPAID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [KAREWAY PRODUCT, INC.] | 1 | Legacy NDC, 6 package rows | 20141024_ff5d54bd-eb48-4383-9b75-6da0ecad1257.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Diphenhydramine Hydrochloride | ACTIVE INGREDIENT | TC2D6JAD40 | 1 | |
| Diphenhydramine | ACTIVE MOIETY | 8GTS82S83M | 1 | |
| FD&C Blue No. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| FD&C Red No. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| gelatin | INACTIVE INGREDIENT | 2G86QN327L | 1 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | 1 | |
| sorbitol | INACTIVE INGREDIENT | 506T60A25R | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Nighttime Sleepaid
- Diphenhydramine Hydrochloride
- Diphenhydramine
- FD&C Blue No. 1
- gelatin
- glycerin
- POLYETHYLENE GLYCOL 400
- water
- FD&C Red No. 40
- sorbitol
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 67510-0557 | 67510-0557-1, 67510-0557-2, 67510-0557-3 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Diphenhydramine Hydrochloride | TC2D6JAD40 | ACTIB |
| FD&C Blue No. 1 | H3R47K3TBD | IACT |
| gelatin | 2G86QN327L | IACT |
| glycerin | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| water | 059QF0KO0R | IACT |
| FD&C Red No. 40 | WZB9127XOA | IACT |
| sorbitol | 506T60A25R | IACT |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET, CHEWABLE / ORAL | 12 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / AURICULAR (OTIC) | 25 mg | ||
| gelatin | GELATIN | 2G86QN327L | TABLET, FILM COATED / ORAL | 57 mg | ||
| gelatin | GELATIN | 2G86QN327L | POWDER / ORAL | 100 mg | ||
| sorbitol | SORBITOL | 506T60A25R | TABLET, COATED / ORAL | 12.96 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAVENOUS | 33750 mg | ||
| sorbitol | SORBITOL | 506T60A25R | PASTE / DENTAL | 14.6 %w/w | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| gelatin | GELATIN | 2G86QN327L | CAPSULE, LIQUID FILLED / ORAL | 1042 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE / ORAL | 3487 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CONCENTRATE / ORAL | 3000 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| sorbitol | SORBITOL | 506T60A25R | POWDER, FOR SUSPENSION / ORAL | 12000 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LOTION / TOPICAL | NA | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / AURICULAR (OTIC) | 63.64 %w/v | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, EXTENDED RELEASE / ORAL | 2.22 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | SHAMPOO / TOPICAL | 2 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | FILM / SUBLINGUAL | 0.07 mg | ||
| sorbitol | SORBITOL | 506T60A25R | INJECTION / INTRAMUSCULAR | NA | ||
| glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAVENOUS | 15 %w/v | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / NASAL | 25 mg/1ml | ||
| glycerin | GLYCERIN | PDC6A3C0OX | EMULSION / INTRAVENOUS | 2.2 %w/v | ||
| sorbitol | SORBITOL | 506T60A25R | EMULSION / TOPICAL | 7 %w/w | ||
| glycerin | GLYCERIN | PDC6A3C0OX | GEL / TRANSDERMAL | 500 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CREAM / TOPICAL | 0.01 %w/w | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CONCENTRATE / ORAL | NA | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | SYRUP / ORAL | 3 mg | ||
| gelatin | GELATIN | 2G86QN327L | TABLET / PERIODONTAL | 3.44 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET, EXTENDED RELEASE / ORAL | 60 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | CONCENTRATE / ORAL | 0.04 mg/1ml | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 0.02 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SOLUTION / OPHTHALMIC | 46 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION, EXTENDED RELEASE / ORAL | 2000 mg | ||
| sorbitol | SORBITOL | 506T60A25R | SYRUP / ORAL | 4370 mg/5ml | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SUSPENSION / ORAL | 400 mg | ||
| sorbitol | SORBITOL | 506T60A25R | SOLUTION, CONCENTRATE / ORAL | 300 mg/1ml | ||
| gelatin | GELATIN | 2G86QN327L | INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR | 2 mg | ||
| sorbitol | SORBITOL | 506T60A25R | CONCENTRATE / ORAL | 600 mg/1ml | ||
| gelatin | GELATIN | 2G86QN327L | SYSTEM / TOPICAL | 1050 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | POWDER, FOR SUSPENSION / ORAL | 3 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SYRUP / ORAL | 16734 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SHAMPOO / TOPICAL | 5 %w/w | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CONCENTRATE / ORAL | 1800 mg | ||
| sorbitol | SORBITOL | 506T60A25R | TABLET / SUBLINGUAL | 50.5 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | INJECTION / INTRAVENOUS | 28216 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | OINTMENT / TOPICAL | 1950 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CREAM / TOPICAL | 1720 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE / ORAL | 16 mg | ||
| gelatin | GELATIN | 2G86QN327L | GUM, CHEWING / BUCCAL | 102 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / TOPICAL | 0.01 %w/w | ||
| glycerin | GLYCERIN | PDC6A3C0OX | PASTE / DENTAL | 20 %w/w | ||
| gelatin | GELATIN | 2G86QN327L | SOLUTION / ORAL | 34.8 mg | ||
| sorbitol | SORBITOL | 506T60A25R | CAPSULE / ORAL | 1111 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | GUM, CHEWING / BUCCAL | 48 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / RESPIRATORY (INHALATION) | 5 %w/w | ||
| glycerin | GLYCERIN | PDC6A3C0OX | LIQUID / ORAL | 2400 mg | ||
| sorbitol | SORBITOL | 506T60A25R | SYSTEM / TOPICAL | 6300 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CAPSULE / ORAL | 13440 mg | ||
| sorbitol | SORBITOL | 506T60A25R | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 1.04 %w/v |
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 |
|---|---|---|---|---|---|---|
| 4294707b-3c0b-4a75-96e0-61a18ba498d7 | ff5d54bd-eb48-4383-9b75-6da0ecad1257 | 2014-10-22 | Warnings | 4294707b-3c0b-4a75-96e0-61a18ba498d7 ff5d54bd-eb48-4383-9b75-6da0ecad1257 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.