WAL SOM NIGHTTIME SLEEP AID- diphenhydramine hcl capsule

Wal Som by

Drug Labeling and Warnings

Wal Som by is a Otc medication manufactured, distributed, or labeled by Walgreen Company, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part338	07/31/2016	03/18/2022

Labeler - Walgreen Company (008965063)

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

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

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

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