HyVee

Manufacturer: HyVee Inc
Effective date: 2026-08-21
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: daily-update
Hydrated at: 2026-09-03 03:02:39

Label at a glance#

ProductHyVee Maximum Strength Nighttime Sleep-Aid SOFTGEL

Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE

Label structure10 sections

Indications and uses

• for relief of occasional sleeplessness

Dosage and administration

• adults and children 12 years of age and over: take 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor

Storage and handling

• store at 20-25°C (68-77° F) • keep bottle tightly closed • protect from light, heat and moisture

Contacts and useful links#

PhoneLabel contact1-888-577-8033

PhoneLabel contact1-800-289-8343

Websitewww.hy-vee.com

www.hy-vee.com

Label contents#

Full prescribing information#

Active ingredient(in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 50 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

• for relief of occasional sleeplessness

Warnings

WARNINGS SECTION

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 serious underlying medical illness.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

• adults and children 12 years of age and over: take 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor

Other information

STORAGE AND HANDLING SECTION

• store at 20-25°C (68-77° F)
• keep bottle tightly closed
• protect from light, heat and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C blue no.1, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol sorbitan solution, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-888-577-8033 Monday-Friday 8am-4pm EST

SPL UNCLASSIFIED SECTION

*Compare to the Active Ingredient of Unisom^® SleepGels^®

Helps Fall Asleep Fast

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

DISTRIBUTED BY HY-VEE, INC.
WEST DES MOINES, IA 50266
STVA0126

PRODUCT OF INDIA

SATISFACTION GUARANTEED
CALL 1-800-289-8343
www.hy-vee.com

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

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom®.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HyVeeMSNighttimeSleep-AidSOFTGEL

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0075450825374	GTIN-13: 0075450825374 EAN-13: 0075450825374 GTIN-12: 075450825374 UPC-A: 075450825374 GTIN storage (14 digits): 00075450825374	42507834-8.jpg
Barcode	EAN-13	0075450856842	GTIN-13: 0075450856842 EAN-13: 0075450856842 GTIN-12: 075450856842 UPC-A: 075450856842 GTIN storage (14 digits): 00075450856842	42507834-8.jpg
QR code link	QR Code	hyvee.info/2MVbY1		42507834-8.jpg
QR code link	QR Code	hyvee.info/FZXBAn		42507834-8.jpg
QR code link	QR Code	hyvee.info/VMEyBM		42507834-8.jpg

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

HyVee Maximum Strength Nighttime Sleep-Aid SOFTGEL
Diphenhydramine hydrochloride
DIPHENHYDRAMINE
FD&C BLUE NO. 1
GELATIN, UNSPECIFIED
GLYCERIN
POLYETHYLENE GLYCOL, UNSPECIFIED
PROPYLENE GLYCOL
SORBITOL
SORBITAN
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
42507-834	42507-834-64, 42507-834-32, 42507-834-96

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIPHENHYDRAMINE HYDROCHLORIDE	TC2D6JAD40	ACTIB
FD&C BLUE NO. 1	H3R47K3TBD	IACT
GELATIN, UNSPECIFIED	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SORBITOL	506T60A25R	IACT
SORBITAN	6O92ICV9RU	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HyVee Maximum Strength Nighttime Sleep-Aid SOFTGEL	DIPHENHYDRAMINE HYDROCHLORIDE	HyVee Inc	496ce4ba-08a9-ee99-e063-6294a90ac9a7	2026-08-21	Warnings	Exact identifier ndc (package): 42507-834-32 ndc (package): 42507-834-64 ndc (package): 42507-834-96 ndc (product): 42507-834 ndc11 (package): 42507083496 ndc11 (package): 42507083464 ndc11 (package): 42507083432 spl id: af9ee2b4-0e9f-407d-b560-a2708a879111 spl set id: 496ce4ba-08a9-ee99-e063-6294a90ac9a7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.