DYE FREE SLEEP AID- diphenhydramine hcl tablet, film coated
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 44-627-Dye Free-Delisted

Active ingredient (in each caplet)

Diphenhydramine HCl 25 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

glaucoma
a breathing problem such as emphysema or chronic bronchitis
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
adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor
children under 12 years: do not use

Other information

each caplet contains: calcium 30 mg
protect from moisture
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
see end flap for expiration date and lot number

Inactive ingredients

corn starch, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc

Questions or comments?

1-800-426-9391

Principal Display Panel

Walgreens

Compare to Simply Sleep® active ingredient††

NDC 0363-6270-12

Dye-Free Sleep Aid

DIPHENHYDRAMINE HCl 25 mg / NIGHTTIME SLEEP AID

DYE FREE NIGHTTIME MINI CAPLETS

• For a restful night's sleep • Does not contain pain reliever
• Safe, non-habit forming

100 MINI-CAPLETS

Actual Size

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Walgreens Pharmacist Recommeneded
Walgreens Pharmacist Survey

††This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Simply Sleep®.

50844 REV1019A62712

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED
walgreens.com ©2018 Walgreen Co.

44-627

DYE FREE SLEEP AID
diphenhydramine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-6270
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	11mm
Flavor		Imprint Code	44;627
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-6270-12	1 in 1 CARTON	12/01/2018	01/14/2023
1		100 in 1 BOTTLE; 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	12/01/2018	01/14/2023

Labeler - Walgreen Company (008965063)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	manufacture(0363-6270) , pack(0363-6270)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	pack(0363-6270)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(0363-6270)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(0363-6270)

Revised: 9/2021

Document Id: 2660b283-dca9-4d11-b0b3-835e7e2896a4

Set id: e8d45ad1-8531-4b0c-84bd-554a1c8cb9d9

Version: 5

Effective Time: 20210909

Walgreen Company