EZ NITE SLEEP AID- diphenhydramine hcl liquid

EZ Nite Sleep Aid by

Drug Labeling and Warnings

EZ Nite Sleep Aid by is a Otc medication manufactured, distributed, or labeled by AAFES/Your Military Exchanges. 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 the skin
• for children under 12 years of age

Ask a doctor before use if you have

• 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

•  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.

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 (50 mg) at bedtime if needed, or as directed by a doctor
• children under 12 years do not use 

Other information

• each 30 mL contains: sodium 23 mg
• store between 20-25ºC (68-77ºF). Do not refrigerate
• 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, trisodium citrate dihydrate

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

*Compare to the active ingredient of ZZZQUIL®

EZ Nite Sleep Aid

NIGHTTIME SLEEP-AID

Diphenhydramine HCI 50 mg

• Non-Habit Forming
• Berry Flavor

Not for treating cold or flu

Alcohol 10%

fl oz (mL)

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

*This product is not manufactured or distributed by The Procter & Gamble Company. ZZZQUIL® is a registered trademark of The Procter & Gamble Company.

Manufactured for Your Military Exchanges

By: PL Developments, 11865 S. Alameda St

Lynowood, CA 90262

Package Label

EXCHANGE SELECT EZ Nite Sleep Aid

INGREDIENTS AND APPEARANCE

EZ NITE SLEEP AID 
diphenhydramine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55301-314
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)
ALCOHOL (UNII: 3K9958V90M)
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: 55301-314-06	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/31/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part338	08/31/2015

Labeler - AAFES/Your Military Exchanges (001695568)