SLEEP AID- diphenhydramine hcl solution
Walgreen Company

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.

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Walgreens 44-002A-Sleep Aid

Active ingredient (in each 30 mL dose cup)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Uses

for relief of occasional sleeplessness
reduces time to fall asleep if you have difficulty falling asleep

Warnings

Do not use

for children under 12 years of age
with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

a breathing problem such as emphysema or chronic bronchitis
glaucoma
difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

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 a 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 right away.

Directions

do not take more than directed
mL = milliliter; FL OZ = fluid ounce
use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
take only one dose per day (24 hours)
adults and children 12 years and over: take 30 mL at bedtime if needed or as directed by a doctor
children under 12 years: do not use

Other information

each 30 mL dose cup contains: sodium 17 mg
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
use by expiration date on package

Inactive ingredients

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, high fructose corn syrup, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, sucrose, xanthan gum

Questions or comments?

1-800-426-9391

Principal display panel

NDC 0363-8020-02

Walgreens

Compare to the active ingredient in
Vicks® ZzzQuil® Nighttime Sleep-Aid††

WALGREENS
PHARMACIST RECOMMENDED†

Sleep Aid
DIPHENHYDRAMINE HCl /
NIGHTTIME SLEEP AID

Nighttime

Alcohol Free

• Non-habit forming

12 FL OZ (355 mL)

Berry
flavor

NOT FOR TREATING PAIN, COLD OR FLU

TAMPER EVIDENT: DO NOT USE IF PRINTED
NECK WRAP IS BROKEN OR MISSING

†Our pharmacists recommend the Walgreens brand.
We invite you to compare to national brands.
††This product is not manufactured or distributed by The
Procter & Gamble Company, owner of the registered
trademark Vicks® ZzzQuil® Nighttime Sleep-Aid.

50844 ORG112000202

DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED walgreens.com ©2021 Walgreen Co.

Walgreens 44-002A

SLEEP AID
diphenhydramine hcl solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-8020
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)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUCROSE (UNII: C151H8M554)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	purple	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0363-8020-45	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/10/2022
2	NDC:0363-8020-02	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/10/2022
3	NDC:0363-8020-96	2 in 1 PACKAGE	03/10/2022
3		355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part338	03/10/2022

Labeler - Walgreen Company (008965063)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	manufacture(0363-8020) , pack(0363-8020)

Revised: 3/2022

Document Id: b674159c-6e29-45c7-bb2c-37b7ed113f86

Set id: f8f17615-e4ec-49d4-9c0d-581d0fd6feb7

Version: 1

Effective Time: 20220310

Walgreen Company