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 at 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

Questions or comments?

1-800-632-6900

Principal Display Panel

*COMPARE TO THE ACTIVE INGREDIENT IN UNISOM® SLEEPGELS®

NightTime Sleep-Aid

Diphenhydramine HCl 50 mg

Nighttime sleep-aid

NON-HABIT FORMING

FALL ASLEEP FAST,

SLEEP SOUNDLY,

WAKE REFRESHED

SOFTGELS

ONE SOFTGEL PER DOSE

*Unisom® and SleepGels® is a registered trademarks of Sanofi Consumer Healthcare NA.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

Package Label

KROGER HEALTH NightTime Sleep-Aid

SLEEP AID
diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:30142-715
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg

Ingredient Name	Strength
Inactive Ingredients
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
Color	blue	Score	no score
Shape	CAPSULE	Size	13mm
Flavor		Imprint Code	PC5
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:30142-715-92	2 in 1 PACKAGE	03/26/2021
1		96 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:30142-715-32	1 in 1 BOX	03/26/2021
2		32 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC:30142-715-96	96 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/26/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M010	03/26/2021

Labeler - The Kroger Co. (006999528)

Drug Facts