EZ NITE SLEEP- diphenhydramine hydrochloride capsule

United States - English - NLM (National Library of Medicine)

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Active ingredient:
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)
Available from:
THE KROGER CO.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Nighttime sleep-aid - for the relief of occasional sleeplessness - reduces time to fall asleep if you have difficulty falling asleep - a breathing problem such as emphysema or chronic bronchitis - glaucoma - difficulty in urination due to enlargement of prostate gland 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.
Authorization status:
OTC monograph final
Authorization number:
30142-229-24

EZ NITE SLEEP- diphenhydramine hydrochloride capsule

THE KROGER CO.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Kroger® NIGHTTIME SLEEP-AID

EZ NITE SLEEP

Drug Facts

ACTIVE INGREDIENT (in each softgel)

Diphenhydramine HCl 25mg

Purpos e

Nighttime sleep-aid

Us es

for the relief of occasional sleeplessness

reduces time to fall asleep if you have difficulty falling asleep

Drug Facts

( continued)

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 a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

avoid alcoholic beverages

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.

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

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

Drug Facts

(continued)

Questions or comments? 1-800-632-6900

PRINCIPAL DISPLAY PANEL

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

NDC 30142-229-24

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.

EZ NITE SLEEP

diphenhydramine hydrochloride capsule

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:30 142-229

Route of Administration

ORAL

THE KROGER CO.

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DIPHENHYDRAMINE HYDRO CHLO RIDE (UNII: TC2D6 JAD40 ) (DIPHENHYDRAMINE -

UNII:8 GTS8 2S8 3M)

DIPHENHYDRAMINE

HYDROCHLORIDE

25 mg

Inactive Ingredients

Ingredient Name

Stre ng th

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

GELATIN (UNII: 2G8 6 QN327L)

GLYCERIN (UNII: PDC6 A3C0 OX)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

SO RBITO L (UNII: 50 6 T6 0 A25R)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

purple

S core

no sco re

S hap e

CAPSULE

S iz e

15mm

Flavor

Imprint Code

6 0 2

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:30 142-229 -24 2 in 1 CARTON

0 4/25/20 19

1

12 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt338

0 4/25/20 19

Labeler -

T HE KROGER CO. (006999528)

Registrant -

Spirit Pharmaceuticals LLC (179621011)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

MEDGEL PRIVATE LIMITED

6 7738 549 8

ma nufa c ture (30 142-229 )

Revised: 9/2020

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