WAL SOM NIGHTTIME SLEEP AID- diphenhydramine hcl capsule
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 44-682

Active ingredient (in each mini-capsule)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Use

for relief of occasional sleeplessness

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 (1-800-222-1222) right away.

Directions

adults and children 12 years and over: take 2 mini-capsules (50 mg) at bedtime if needed, or as directed by a doctor

Other information

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

Inactive ingredients

butylparaben, corn starch, FD&C blue #1, FD&C red #3, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, povidone, propylene glycol, propylparaben, shellac, silicon dioxide, sodium hydroxide, titanium dioxide

Questions or comments?

1-800-426-9391

Principal display panel

Well at
Walgreens
WALGREENS PHARMACIST RECOMMENDED‡

NIGHTTIME SLEEP AID
Wal-Som®
Diphenhydramine HCl 25 mg /
Nighttime Sleep Aid
• Easy to swallow
• Non-habit forming

60
MINI-CAPSULES

Actual Size

Compare to Unisom® SleepMinis™ active ingredient‡‡

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

†Walgreens Pharmacist Survey
Study, November 2014
‡‡This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepMinis™.
50844 REV0216A68211
Walgreens 44-682

Walgreens 44-682

WAL SOM NIGHTTIME SLEEP AID
diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0682
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
BUTYLPARABEN (UNII: 3QPI1U3FV8)
STARCH, CORN (UNII: O8232NY3SJ)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
GELATIN (UNII: 2G86QN327L)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SHELLAC (UNII: 46N107B71O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BLUE (blue and blue banded)	Score	no score
Shape	OVAL	Size	14mm
Flavor		Imprint Code	44;682
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-0682-11	1 in 1 CARTON	07/31/2016	03/18/2022
1		60 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	07/31/2016	03/18/2022

Labeler - Walgreen Company (008965063)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(0363-0682)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	MANUFACTURE(0363-0682) , PACK(0363-0682)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	PACK(0363-0682)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	PACK(0363-0682)

Revised: 4/2019

Document Id: 970f93ee-cb83-46f7-9fd8-0642565631c9

Set id: 93b010a8-85af-4beb-8960-19291a1a0332

Version: 5

Effective Time: 20190423

Walgreen Company