SLEEP II NIGHTTIME SLEEP AID- diphenhydramine hcl tablet

Sleep II by

Drug Labeling and Warnings

Sleep II 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 tablet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Use

• 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 tablets at bedtime if needed or as directed by a doctor
• children under 12 years: do not use

Other information

• each tablet contains: calcium 60 mg
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• see end flap for expiration date and lot number
• protect from moisture

Inactive ingredients

croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

Questions or comments?

1-800-426-9391

Primary Display Panel

Walgreens

Compare to Original Formula Sominex® active ingredient††

NDC: 0363-0189-46

NIGHTTIME SLEEP AID
Sleep II
DIPHENHYDRAMINE HCl 25 mg / NIGHTTIME SLEEP AID

NIGHTTIME  TABLETS

Sleep-aid 

96
TABLETS

ACTUAL SIZE

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

†Walgreens Pharmacist Survey

††This product is not manufactured or distributed by Medtech Products Inc., owner of the registered trademark Original Formula Sominex®.

50844  REV1019A18946

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

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

Walgreens 44-189

INGREDIENTS AND APPEARANCE

SLEEP II  NIGHTTIME SLEEP AID
diphenhydramine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0189
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	BLUE	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	44;189
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0189-21	2 in 1 CARTON	04/10/1990	07/08/2018
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 0363-0189-08	3 in 1 CARTON	04/10/1990
2		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 0363-0189-23	1 in 1 CARTON	04/10/1990
3		72 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 0363-0189-46	1 in 1 CARTON	04/10/1990
4		96 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	04/10/1990

Labeler - Walgreen Company (008965063)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(0363-0189)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(0363-0189)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(0363-0189)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(0363-0189)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(0363-0189)