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NDC 49035-0675-12 EZ Nite Sleep Aid 50 mg/30mL Details

EZ Nite Sleep Aid 50 mg/30mL

EZ Nite Sleep Aid is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC). The primary component is DIPHENHYDRAMINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Related Packages: 49035-0675-12
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenhydramine

Product Information

NDC	49035-0675
Product ID	49035-675_8f854387-8040-4a28-8af3-c20ec13efe10
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	EZ Nite Sleep Aid
Proprietary Name Suffix	n/a
Non-Proprietary Name	Diphenhydramine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	50
Active Ingredient Units	mg/30mL
Substance Name	DIPHENHYDRAMINE HYDROCHLORIDE
Labeler Name	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part338
Listing Certified Through	n/a

Package

Package Images

NDC 49035-0675-12 (49035067512)

Pricing Information	N/A
NDC Package Code	49035-675-12
Billing NDC	49035067512
Package	355 mL in 1 BOTTLE, PLASTIC (49035-675-12)
Marketing Start Date	2015-10-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e30d3c0c-f04f-4909-8093-57519d26b6b6 Details

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
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

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 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, 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

non habit forming
berry flavor

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

Equate 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:49035-675
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
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
Shape		Size
Flavor	BERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49035-675-12	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/31/2015	01/31/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part338	10/31/2015	01/31/2025

Labeler - EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) (051957769)

Revised: 10/2022

Document Id: 8f854387-8040-4a28-8af3-c20ec13efe10

Set id: e30d3c0c-f04f-4909-8093-57519d26b6b6

Version: 3

Effective Time: 20221025