SLEEP AID- diphenhydramine hcl tablet, film coated

Sleep Aid by

Drug Labeling and Warnings

Sleep Aid by is a Otc medication manufactured, distributed, or labeled by Harmon Store Inc., 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

Use

for relief of occasional sleeplessness

Warnings

Do not use

• in 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

• drowsiness will occur
• avoid alcoholic beverages
• use caution when driving a motor vehicle or operating machinery

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

• 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
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• protect from moisture
• use by expiration date on package

Inactive ingredients

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

Questions or comments?

1-800-426-9391

Principal Display Panel

CORE VALUES™

Compare to active ingredient in
Simply Sleep®†

NDC: 63940-627-03

Sleep Aid

Diphenhydramine HCl 25 mg
Nighttime Sleep-Aid

Dye-Free Non-habit Forming

Actual Size

10 coated caplets

TAMPER EVIDENT: Use Only if This Blister is Intact

†This product is not
manufactured or distributed by
McNeil Consumer Healthcare,
owner of the registered
trademark Simply Sleep®.

50844     REV0516A62703

Satisfaction Guaranteed Or Your Money Back
Visit us at www.facevalues.com

Distributed by:
Liberty Procurement, Inc., 650 Liberty Ave., Union, NJ 07083 U.S.A.

Core Values 44-627

INGREDIENTS AND APPEARANCE

SLEEP AID 
diphenhydramine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63940-627
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
STARCH, CORN (UNII: O8232NY3SJ)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63940-627-03	1 in 1 PACKAGE	07/01/2013
1		10 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	07/01/2013

Labeler - Harmon Store Inc. (804085293)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(63940-627)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(63940-627)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(63940-627)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	MANUFACTURE(63940-627) , PACK(63940-627)