Dosage and administration
adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor
Night Time Sleep Aid
- Manufacturer
- Hy-Vee
- Effective date
- 2020-10-28
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:09:35
Label at a glance#
ProductNight Time Sleep Aid
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections
Storage and handling
store at 15°-30°C (59°-86°F)
Contacts and useful links#
Websitewww.hy-vee.com
www.hy-vee.com
www.hy-vee.comLabel contents#
Full prescribing information#
Active ingredient (in each softgel)
Diphenhydramine HCl 50 mg
Purpose
Nighttime sleep-aid
Use
for relief of occasional sleeplessness.
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
Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizers.
When using this product
avoid alcoholic drinks.
Stop use and ask a doctor if
sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor
Other information
- store at 15°-30°C (59°-86°F)
Inactive ingredients
edible white ink, FD&C blue #1, gelatin, glycerin, light mineral oil*, polyethylene glycol, purified water, sorbitol-sorbitan
*may contain this ingredient
Questions or comments?
Call toll free 1-800-289-8343 Monday-Friday 9AM-4PM CST
Principal Display Panel
†Compare to the Active Ingredient of Unisom® SleepGels®
Maximum Strength
Night Time Sleep Aid
DIPHENHYDRAMINE HCl, 50 mg
Safe, Non-Habit Forming
- Fall Asleep Fast
- Sleep Soundly
- Wake up Refreshed
SOFTGELS**
(**LIQUID FILLED)
†This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepGels®.
DISTRIBUTED BY HY-VEE, INC.
5820 WESTOWN PARKWAY
WEST DES MOINES, IA 50266
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
Package Label
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | ACTIVE INGREDIENT | TC2D6JAD40 | 3 | |
| DIPHENHYDRAMINE | ACTIVE MOIETY | 8GTS82S83M | 3 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 3 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | 3 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 3 | |
| LIGHT MINERAL OIL | INACTIVE INGREDIENT | N6K5787QVP | 3 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 3 | |
| SORBITAN | INACTIVE INGREDIENT | 6O92ICV9RU | 3 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 3 |
Products#
Every source-derived product name is available through these pages.
- Night Time Sleep Aid
- Diphenhydramine HCl
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
- FD&C BLUE NO. 1
- GELATIN
- GLYCERIN
- LIGHT MINERAL OIL
- POLYETHYLENE GLYCOL, UNSPECIFIED
- WATER
- SORBITAN
- SORBITOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 42507-236 | 42507-236-32 |
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 |
| LIGHT MINERAL OIL | N6K5787QVP | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITAN | 6O92ICV9RU | 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 | SUPPOSITORY / VAGINAL | 227.9 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | EMULSION / TOPICAL | 7 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / AURICULAR (OTIC) | 25 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | PASTE, DENTIFRICE / DENTAL | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET / ORAL | 337.28 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DROPS / NASAL | 10 mg/1ml | ||
| SORBITOL | SORBITOL | 506T60A25R | SUSPENSION / RECTAL | 46.18 %w/v | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SUSPENSION / ORAL | 1 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | GEL / TOPICAL | 20 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | AEROSOL, FOAM / TOPICAL | 21 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / TOPICAL | 1720 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | LIQUID / ORAL | 53460 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, FILM COATED / ORAL | 57 mg | ||
| GELATIN | GELATIN | 2G86QN327L | SYSTEM / TOPICAL | 1050 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DOUCHE / VAGINAL | 1 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOAP / TOPICAL | 0.01 %w/w | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | LOTION / TOPICAL | 48000 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / NASAL | 25 mg/1ml | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LOTION / TOPICAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE / ORAL | 3487 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE / ORAL | 26.3 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / ORAL | 750 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYSTEM / IONTOPHORESIS | 168.1 mg | ||
| GELATIN | GELATIN | 2G86QN327L | DROPS / NASAL | 50 mg/1ml | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRAVENOUS | 1276 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRAMUSCULAR | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION, SOLUTION / SUBCUTANEOUS | 4.7 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYRUP / ORAL | 16734 mg | ||
| GELATIN | GELATIN | 2G86QN327L | WAFER / ORAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / ORAL | 32400 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SYSTEM / TOPICAL | 6300 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / SUBLINGUAL | 0.03 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | EMULSION / OPHTHALMIC | 3 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAMUSCULAR | 450 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, FILM COATED / ORAL | 0.16 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CONCENTRATE / BUCCAL | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRASYNOVIAL | 45 %w/v | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, EXTENDED RELEASE / ORAL | 428 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | OINTMENT / TOPICAL | 1335 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / AURICULAR (OTIC) | 0.05 %w/w | ||
| GELATIN | GELATIN | 2G86QN327L | SUPPOSITORY / VAGINAL | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, ORALLY DISINTEGRATING / ORAL | 7 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPONGE / TOPICAL | 2 %w/w | ||
| GELATIN | GELATIN | 2G86QN327L | GUM, CHEWING / BUCCAL | 102 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, LIQUID FILLED / ORAL | 185 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION / NASAL | 25 mg/1ml | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, DELAYED RELEASE / ORAL | 2 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | CAPSULE / ORAL | 6 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | EMULSION / TOPICAL | 68100 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAVENOUS | 33750 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / ORAL | 27.53 mg | ||
| GELATIN | GELATIN | 2G86QN327L | DROPS / ORAL | NA | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | CREAM / TOPICAL | 456 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, CHEWABLE / ORAL | 12 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | POWDER / ORAL | 36000 mg | ||
| GELATIN | GELATIN | 2G86QN327L | PASTILLE / ORAL | 143 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / TOPICAL | 0.01 %w/w |
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 |
|---|---|---|---|---|---|---|
| 41a21795-120b-406e-8da1-7361d08f7521 | 9c6ad2ac-6196-4bd0-a4a0-2bd86f1f49fc | 2020-10-28 | Warnings | 41a21795-120b-406e-8da1-7361d08f7521 9c6ad2ac-6196-4bd0-a4a0-2bd86f1f49fc |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.