EZ NITE SLEEP- diphenhydramine hcl liquid

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]

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	03/31/2015

Labeler - The Kroger Co. (006999528)