SLEEP AID NIGHTTIME- diphenhydramine hcl tablet, film coated

Sleep Aid by

Drug Labeling and Warnings

Sleep Aid 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 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

• 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
• 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 
• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
• protect from moisture
• store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
• see end flap for expiration date and lot number

Inactive ingredients

corn starch, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

Walgreens
Compare to Simply Sleep® active ingredient††

NDC: 0363-0367-08

Sleep Aid
DIPHENHYDRAMINE HCl 25 mg / NIGHTTIME SLEEP AID

NIGHTTIME         MINI CAPLETS

For a restful night's sleep  
Does not contain pain reliever
Non-habit forming

24 MINI-CAPLETS

ACTUAL SIZE

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

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

50844    REV1019A36708

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
Walgreens
100% SATISFACTION
          GUARANTEED
walgreens.com  ©2018 Walgreen Co.

Walgreens 44-367

INGREDIENTS AND APPEARANCE

SLEEP AID  NIGHTTIME
diphenhydramine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0367
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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, CORN (UNII: O8232NY3SJ)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)

Product Characteristics
Color	BLUE	Score	no score
Shape	OVAL	Size	11mm
Flavor		Imprint Code	44;367
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0367-08	2 in 1 CARTON	06/10/2000
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 0363-0367-91	1 in 1 CARTON	06/10/2000	10/02/2021
2		125 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 0363-0367-13	1 in 1 CARTON	06/10/2000
3		250 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 0363-0367-12	1 in 1 CARTON	06/10/2000
4		100 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	06/10/2000

Labeler - Walgreen Company (008965063)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(0363-0367)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(0363-0367)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	MANUFACTURE(0363-0367) , PACK(0363-0367)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(0363-0367)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(0363-0367)