SLEEP AID MAXIMUM STRENGTH- diphenhydramine hcl capsule, liquid filled

Sleep Aid by

Drug Labeling and Warnings

Sleep Aid by is a Otc medication manufactured, distributed, or labeled by GREENBRIER INTERNATIONAL, INC., Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each liquid-filled capsule)

Diphenhydramine HCl 50 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

• 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 (1-800-222-1222) right away.

Directions

• adults and children 12 years and over: 1 capsule (50 mg) at bedtime if needed, or as directed by a doctor

Other information

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

Inactive ingredients

edible white ink, FD&C blue #1, gelatin, glycerin, lecithin, mineral oil, polyethylene glycol, purified water, sorbitol

Questions or comments?

1-800-426-9391

Principal display panel

ASSURED™

COMPARE TO ACTIVE INGREDIENT OF
UNISOM® SLEEPGELS®*

MAXIMUM STRENGTH
Sleep Aid

Diphenhydramine HCI 50 mg
Nighttime Sleep-Aid

Helps reduce difficulty falling asleep
Fast acting, Non-habit forming

Actual Size

8 softgels

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

ITEM # 934526
DISTRIBUTED BY
GREENBRIER INTERNATIONAL, INC.
500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

*This product is not manufactured or distributed by
Chattem, Inc., owner of the registered trademark
Unisom® SleepGels®.  50844    REV0315A65619

Product of China
Packaged and Quality Assured in the USA

Assured 44-656

INGREDIENTS AND APPEARANCE

SLEEP AID  MAXIMUM STRENGTH
diphenhydramine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 33992-0656
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
MINERAL OIL (UNII: T5L8T28FGP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)

Product Characteristics
Color	BLUE (clear)	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	656
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 33992-0656-9	1 in 1 CARTON	03/01/2015	10/29/2022
1		8 in 1 BLISTER PACK; 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	03/01/2015	10/29/2022

Labeler - GREENBRIER INTERNATIONAL, INC. (610322518)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(33992-0656)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(33992-0656)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(33992-0656)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(33992-0656)