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EZ Nite Sleep Aid by AAFES/Your Military Exchanges

Dosage form: liquid
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 50mg in 30mL
Labeler: AAFES/Your Military Exchanges
NDC Code: 55301-314

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

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
  • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products, and other nighttime sleep-aids

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 directed can cause serious health problems. in case of overdose, get medical help or contact a Poison Control Center right away.

Directions
  • take only one dose per day (24 hours) - (see overdose warning)
  • mL=milliliter
  • shake well before using
  • 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 at 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

EZ Nite Sleep

Nighttime Sleep Aid

Diphenhydramine HCI 50 mg

Non-habit forming

*Compare to the active igredient in ZzzQuil®

Not for treating cold or flu

Berry Flavor

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 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

EZ NITE SLEEP AID 
diphenhydramine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55301-314
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE50 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
PROPYLENE GLYCOL 
POLYOXYL 40 STEARATE 
WATER 
SODIUM BENZOATE 
SACCHARIN SODIUM ANHYDROUS 
TRISODIUM CITRATE DIHYDRATE 
HIGH FRUCTOSE CORN SYRUP 
FD&C BLUE NO. 1 
ALCOHOL 
FD&C RED NO. 40 
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:55301-314-06177 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/31/2015
Labeler - AAFES/Your Military Exchanges (001695568)

Revised: 09/2015
 
AAFES/Your Military Exchanges

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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