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EZ Nite Sleep by P & L Development, LLC

Medically reviewed on February 2, 2017

Dosage form: liquid
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 50mg in 30mL
Labeler: P & L Development, LLC
NDC Code: 49580-0242

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

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

EZ NITE SLEEP 
zzzquil liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49580-0242
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
CITRIC ACID MONOHYDRATE 
PROPYLENE GLYCOL 
POLYOXYL 40 STEARATE 
WATER 
SODIUM BENZOATE 
SACCHARIN SODIUM 
SODIUM CITRATE 
HIGH FRUCTOSE CORN SYRUP 
FD&C BLUE NO. 1 
ALCOHOL 
FD&C RED NO. 40 
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRY (Berry Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:49580-0242-2355 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34101/01/2013
Labeler - P & L Development, LLC (101896231)

 
P & L Development, LLC

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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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