SLEEP AID- diphenhydramine hcl capsule, liquid filled

Sleep Aid by

Drug Labeling and Warnings

Sleep Aid by is a Otc medication manufactured, distributed, or labeled by L.N.K. International, Inc., 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

Uses

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

• a breathing problem such as emphysema or chronic bronchitis
• difficulty in urination due to enlargement of the prostate gland
• glaucoma

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 of age 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, polyethylene glycol, purified water, sorbitol

Questions or comments?

​1-800-426-9391

Principal display panel

QUALITY PLUS                                           NDC: 50844-656-19

                                               *Compare to active ingredient in Unisom® SleepGels®

SLEEP AID

Diphenhydramine HCl 50 mg
NIGHTTIME SLEEP-AID

Non-habit Forming

8
Liquid Gels                     One Liquid Gel Per Dose            ACTUAL SIZE

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

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepGels®.   
50844   REV0319B65619

Distributed by LNK INTERNATIONAL, INC.
60 Arkay Drive
Hauppauge, NY 11788
USA
Product of China
Packaged and Quality Assured in the USA

Quality Plus 44-656

INGREDIENTS AND APPEARANCE

SLEEP AID 
diphenhydramine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50844-656
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 (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	BLUE (light)	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: 50844-656-19	1 in 1 CARTON	03/01/2015
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 50844-656-27	1 in 1 CARTON	03/01/2015
2		32 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	03/01/2015

Labeler - L.N.K. International, Inc. (038154464)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(50844-656)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(50844-656)