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 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 30 mL, 2 tablespoons)

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

• 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

• heart disease
• glaucoma
• breathing problem such as occurs with asthma or emphysema or chronic bronchitis
• trouble urinating due to an enlarged prostate gland

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

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: Taking more than the recommended dose (overdose) may cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

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

• adults and children 12 years & over: one dose = 2 tablespoons (30 mL) at bed time if needed or as directed by a doctor

Other information

• each 30 mL (2 tbsp) contains: sodium 23 mg
• store at room temperature
• protect from light

Inactive ingredients

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

Questions or comments?

 1-888-309-9030

Principal Display Panel

Nite Time Sleep Aid Liquid

Diphenhydramine HCI

Compare to active igredient in Vicks® ZzzQuil™

• Non-habit forming
• Not for treating cold or flu

Berry Flavor

Alcohol 10%

fl oz (mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL IS BROKEN OR MISSING.

*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® ZzzQuil™.

DISTRIBUTED BY DOLGENCORP, LLC

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072 USA

Dollar General Nite Time Sleep Aid Liquid

INGREDIENTS AND APPEARANCE

EZ NITE SLEEP 
zzzquil liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-242
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: 55910-242-12	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2013	01/01/2021

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

Labeler - Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) (068331990)