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NDC 30142-0375-12 EZ Nite Sleep 50 mg/30mL Details

EZ Nite Sleep 50 mg/30mL

EZ Nite Sleep is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by The Kroger Co.. The primary component is DIPHENHYDRAMINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Related Packages: 30142-0375-12
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenhydramine

Product Information

NDC	30142-0375
Product ID	30142-375_67bffa9f-55b4-4eb5-9f6a-4168ebf79314
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	EZ Nite Sleep
Proprietary Name Suffix	n/a
Non-Proprietary Name	Diphenhydramine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	50
Active Ingredient Units	mg/30mL
Substance Name	DIPHENHYDRAMINE HYDROCHLORIDE
Labeler Name	The Kroger Co.
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	n/a

Package

Package Images

NDC 30142-0375-12 (30142037512)

Pricing Information	N/A
NDC Package Code	30142-375-12
Billing NDC	30142037512
Package	355 mL in 1 BOTTLE, PLASTIC (30142-375-12)
Marketing Start Date	2015-03-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8470b8b8-3462-49fd-aa40-51c666f38fe5 Details

Active ingredient (in each 30 mL)

Diphenhydramine HCl 50 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

with any other product containing diphenhydramine, even one used on skin
for children under 12 years of age

Ask a doctor before use if you have

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 beverages.

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.

Keep out of reach of children.

Overdose warning: 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)
mL=milliliter
measure only with dosing cup provided. Do not use any other dosing device
keep dosing cup with product
adults and children 12 years and over
- one dose = 30mL at bedtime if needed, or as directed by a doctor
children under 12 years do not use

Other information

each 30 mL contains: sodium 24 mg
store between 20-25ºC (68-77ºF). Do not refrigerate.
protect from light

Inactive ingredients

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, polyoxyl 40 stearate, propylene glycol, purified water, saccharin sodium anhydrous, sodium benzoate, trisodium citrate dihydrate

Questions or comments?

1-800-632-6900

Principal Display Panel

COMPARE TO the active ingredient of VICKS® ZZZQUIL®

*See back panel

EZ Nite Sleep

Diphenhydramine HCI 50 mg

Nighttime Sleep-Aid

Non-Habit Forming

Alcohol Free

Not for treating cold or flu

Berry Flavor

fl oz (mL)

Failure to follow these warnings could results in serious consequenses.

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

*Vicks® ZZZQUIL® is a registered trademark of The Procter & Gamble Company, Cincinnati, OH 45202.The Procter & Gamble Company is not Affiliated with the Kroger Co. or this product.

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

www.kroger.com

Package Label

KROGER EZ Nite Sleep

INGREDIENTS AND APPEARANCE

EZ NITE SLEEP

diphenhydramine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:30142-375
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 in 30 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color		Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:30142-375-06	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/31/2015	03/29/2024
2	NDC:30142-375-12	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/31/2015	03/29/2024
3	NDC:30142-375-24	2 in 1 PACKAGE	03/31/2015	03/29/2024
3		355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	03/31/2015	03/29/2024

Labeler - The Kroger Co. (006999528)

Revised: 11/2021

Document Id: 67bffa9f-55b4-4eb5-9f6a-4168ebf79314

Set id: 8470b8b8-3462-49fd-aa40-51c666f38fe5

Version: 4

Effective Time: 20211108