Sleep Aid by Hy-Vee Drug Facts

Sleep Aid by

Drug Labeling and Warnings

Sleep Aid by is a Otc medication manufactured, distributed, or labeled by Hy-Vee. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SLEEP AID- diphenhydramine hcl capsule 
Hy-Vee

----------

Drug Facts

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 (1-800-222-1222) 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 between 15-30°C (59°-86°F)

Inactive ingredients

FD&C blue #1, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, purified water, sorbitol, sorbitan, white ink

Principal Display Panel

*Compare to the active ingredient in Unisom® SleepGels®

Sleep-Aid

Diphenhydramine HCl 50 mg

Nighttime sleep-aid

  • Fall asleep fast
  • Sleep soundly
  • Wake up refreshed

Softgels

One Softgel Per Dose

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

†This product is not manufactured or distributed by Sanofi Consumer Healthcare NA, distributor of Unisom® SleepGels®.

DISTRIBUTED BY HY-VEE, INC.

5820 WESTOWN PARKWAY

WEST DES MOINES, IA 50266

Package Label

Diphenhydramine HCl 50 mg

HY VEE Nighttime Sleep-Aid

SLEEP AID 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 42507-600
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MANNITOL (UNII: 3OWL53L36A)  
Product Characteristics
ColorblueScoreno score
ShapeOVALSize13mm
FlavorImprint Code PC5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 42507-600-321 in 1 BOX12/01/202503/12/2026
132 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01010/10/202503/12/2026
Labeler - Hy-Vee (006925671)

Revised: 3/2026

Trademark Results [Sleep Aid]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SLEEP AID
SLEEP AID
97858312 not registered Live/Pending
Shenzhen Kaiwensi Electronic Commerce Co., Ltd.
2023-03-27
SLEEP AID
SLEEP AID
97847521 not registered Live/Pending
Shenzhen Kaiwensi Electronic Commerce Co., Ltd.
2023-03-20
SLEEP AID
SLEEP AID
97765561 not registered Live/Pending
Shenzhen Kaiwensi Electronic Commerce Co., Ltd.
2023-01-24
SLEEP AID
SLEEP AID
88743606 not registered Live/Pending
Plant Therapy LLC
2019-12-31
SLEEP AID
SLEEP AID
78688138 3120450 Dead/Cancelled
T. Harmon Inc.
2005-08-08
SLEEP AID
SLEEP AID
77928191 not registered Dead/Abandoned
EVEREST NUTRITION CORP
2010-02-04
SLEEP AID
SLEEP AID
77448243 not registered Dead/Abandoned
HEALCEUTICALS, LLC
2008-04-15

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.