SLEEP AID MAXIMUM STRENGTH- diphenhydramine hcl capsule, liquid filled
GREENBRIER INTERNATIONAL, INC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Assured 44-656-Delisted

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

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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part338	03/01/2015	10/29/2022

Labeler - GREENBRIER INTERNATIONAL, INC. (610322518)

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

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

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

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

Revised: 11/2019

Document Id: 1cf67233-2fe5-4f2f-9c1d-650d41da2085

Set id: ddde8663-331e-4d28-9447-3c62601bc2e1

Version: 6

Effective Time: 20191119

GREENBRIER INTERNATIONAL, INC.