EZ NITE SLEEP- diphenhydramine hydrochloride capsule

EZ NITE SLEEP by

Drug Labeling and Warnings

EZ NITE SLEEP by is a Otc medication manufactured, distributed, or labeled by THE KROGER CO.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT (in each softgel)

Diphenhydramine HCl 25mg

Purpose

Nighttime sleep-aid

Uses

• for the relief of occasional sleeplessness
• reduces time to fall asleep if you have difficulty falling asleep

SPL UNCLASSIFIED SECTION

Drug Facts (continued)

WARNINGS

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
• difficulty in urination due to enlargement of prostate gland

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are  taking sedatives or tranquilizers 

WHEN USING

When using this product 

• avoid alcoholic beverages

STOP USE

Stop use and ask a doctor if sleeplessness persists continously for more than 2 weeks. Insomnia may be a symptom be a symptom of serious underlying medical illness.

PREGNANCY OR BREAST FEEDING

If pregnant of breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In care of overdose, get medical help or contact a Poison Control Center right away.

Directions

• take only one dose per day (24 hours)

• adults & children 12 years & over: One dose= TWO 25 mg softgels (50 mg) at bed time if needed or as directed by a doctor
• children under 12 years: 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#1, FD&C Red#40, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

SPL UNCLASSIFIED SECTION

Drug Facts (continued)

QUESTIONS

Questions or comments? 1-800-632-6900

PRINCIPAL DISPLAY PANEL

COMPARE TO the active ingredient of ZZZQUIL® *see side panel

NDC: 30142-224-24

Kroger®

Nighttime Sleep-Aid

EZ Nite Sleep

Diphenhydramine HCL 25 mg

Helps Reduce Difficulty Faling Asleep

actual size

Non-Habit Forming

Not fro Treating Cold or Flu- See Warnings

24 SOFTGELS

*Zzzquil® is a registered trademark of The Procter & Gamble Company, Cincinnati, OH 45202. The Procter & Gamble Comopany is not affiliated with The Kroger Co. ir this product.

INGREDIENTS AND APPEARANCE

EZ NITE SLEEP 
diphenhydramine hydrochloride capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-229
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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	purple	Score	no score
Shape	CAPSULE	Size	15mm
Flavor		Imprint Code	602
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30142-229-24	2 in 1 CARTON	04/25/2019
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 final	part338	04/25/2019

Labeler - THE KROGER CO. (006999528)

Registrant - Spirit Pharmaceuticals LLC (179621011)

Establishment
Name	Address	ID/FEI	Business Operations
MEDGEL PRIVATE LIMITED		677385498	manufacture(30142-229)