EZ NITE SLEEP AID- diphenhydramine hcl liquid 
EQUATE (Wal-Mart Stores, Inc.)

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

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
  • a breathing problem such as asthma, 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


Other information

Inactive ingredients

citric acid, 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

Questions or comments?

Call 1-888-287-1915

Principal Display Panel

Compare to ZZZQUIL® Active Ingredient*

EZ Nite Sleep Aid

Diphemhydramine HCl 50 mg

Nighttime Sleep-Aid

Alcohol free

Not for treating Cold or Flu

See Warnings

FL OZ (mL)

Failure to follow these warnings could result in serious consequences

Distributed by: Wal-Mart Stores, Inc.,

Bentonville, AR 72716

*This product is not manufactured or distributed by The Procter & Gamble Company.

ZZZQUIL® is a registered trademark of The Procter & Gamble Company.

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

Package Label

Diphenhydramine HCl 50 mg

Equate EZ Nite Sleep Aid

EZ NITE SLEEP AID 
diphenhydramine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-675
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
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)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49035-675-12355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/31/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33810/31/2015
Labeler - EQUATE (Wal-Mart Stores, Inc.) (051957769)

Revised: 12/2019
Document Id: 70e3b33d-9de3-45a5-9903-d14a2b742cd3
Set id: e30d3c0c-f04f-4909-8093-57519d26b6b6
Version: 2
Effective Time: 20191211
 
EQUATE (Wal-Mart Stores, Inc.)