EZ NITE SLEEP- diphenhyramine hydrochloride capsule, liquid filled

EZ Nite Sleep by

Drug Labeling and Warnings

EZ Nite Sleep by is a Otc medication manufactured, distributed, or labeled by KROGER COMPANY, TIME CAP LABORATORIES, INC, MARKSANS PHARMA LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (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

Do not use
■ for children under 12 years of age
■ with any other product containing diphenhydramine, even one used on skin.

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
■ difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers

When using this product
■ avoid alcoholic beverages

Stop use and ask a doctor ifsleeplessness 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.

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

■ take only one dose per day (24 hours)

• adults & children 12 yrs & over: 2 softgels at bedtime if needed or as directed by a doctor
• children under 12 yrs: do not use

Other information

■ store at 20-25° C (68-77°F)
■ avoid excessive heat above 40°C (104°F)
■ protect from light

Inactive ingredients

FD&C blue no. 1, FD&C red no. 40, gelatin, polyethylene glycol 400, propylene glycol, purified water, shellac,sorbitol sorbitan solution, titanium dioxide.

QUESTIONS

Questions or comments? Call 1-800-632-6900

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EZ NITE SLEEP 
diphenhyramine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41226-613
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SHELLAC (UNII: 46N107B71O)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	purple (Purple,translucent)	Score	no score
Shape	CAPSULE (oblong shaped)	Size	16mm
Flavor		Imprint Code	121
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41226-613-24	2 in 1 CARTON	04/15/2024
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M010	04/15/2024

Labeler - KROGER COMPANY (006999528)

Registrant - TIME CAP LABORATORIES, INC (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		925822975	manufacture(41226-613)