EZ NITE SLEEP- zzzquil liquid

EZ Nite Sleep by

Drug Labeling and Warnings

EZ Nite Sleep by is a Otc medication manufactured, distributed, or labeled by P & L Development, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

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

Do Not Use

for children under 12 years of age

with any other product containing diphenhydramine, even one used on the skin

with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

do not use with Nyquil

Ask a doctor before use if you have

glaucoma

heart disease
trouble urinating due to an enlarged prostate gland
a breathing problem such as emphysema or
chronic bronchitis

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers or any other sleep-aid

When using this product

 drowsiness will occur
avoid alcoholic drinks and other drugs that cause drowsiness
be careful when driving a motor vehicle or operating machinery

Keep this and all drugs out of the reach of children.

Overdose warning: taking more than the recommended dose (overdose) may cause serious health problems. In case of overdose, get medical help or contact Poison Control CEnter 1-800-222-1222 immediately.

Directions

take only one dose per day (24 hours)
use dosage cup provided
tbsp=tablespoon, mL=milliliter

agedose
adults and children 12 years and over      one dose = 2 tablespoons, 30mL at bedtime if needed or as directed by a doctor

Other information

each 30mL 2tbsp contains: sodium 23 mg
store at controlled room temperature

protect from light

Inactive ingredients

citric acid, ethyl alcohol, fd and c blue 1, fd and c red 40, flavor, high fructose corn syrup, polyoxyl 40 stearate, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate dihydrate

Principal Display Panel

EZ nite sleep nighttime sleep aid

Berry

Diphenhydramine HCI

non habit forming

not for treating cold or flu

alcohol 10 percent

compare to active igredient in Vicks Zzzquil

12 fl oz 355mL

INGREDIENTS AND APPEARANCE

EZ NITE SLEEP 
zzzquil liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49580-0242
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ALCOHOL (UNII: 3K9958V90M)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color		Score
Shape		Size
Flavor	BERRY (Berry Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49580-0242-2	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2013	12/30/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	01/01/2013	12/30/2021

Labeler - P & L Development, LLC (101896231)