SLEEP AID- diphenhydramine hcl capsule, liquid filled
L.N.K. 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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Quality Plus 44-293-Delisted

Active ingredients (in each softgel)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Uses

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
trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

avoid alcoholic drinks.

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

adults and children 12 years and over: 1 softgel at bedtime if needed, or as directed by a doctor

Other information

store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
protected from light
see end flap for expiration date and lot number

Inactive ingredients

edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, sorbitol

Questions or comments?

1-800-426-9391

Principal display panel

NDC 50844-293-19

QUALITY PLUS

Compare to the active ingredient in Unisom® SleepGels®*

Sleep Aid
Diphenhydramine HCl 50 mg

Nighttime Sleep-Aid
Safe, Non-habit Forming
Fall Asleep Fast/Safee

8 Softgels
One Softgel Per Dose

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepGels®.
50844 REV0412A29319
Distributed by LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788
USA
Product of Canada

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

Quality Plus 44-293

SLEEP AID
diphenhydramine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50844-293
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
GELATIN (UNII: 2G86QN327L)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	BLUE	Score	no score
Shape	CAPSULE	Size	13mm
Flavor		Imprint Code	A99
Contains

#	Item Code	Package Description
Packaging
1	NDC:50844-293-19	1 in 1 CARTON
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	part336	04/08/2004	06/09/2018

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

Name	Address	ID/FEI	Business Operations
Establishment
Accucaps Industries, Ltd.		248441727	MANUFACTURE(50844-293)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(50844-293)

Revised: 6/2015

Document Id: 82ba4121-1a06-4ad7-8169-6284162fbfc4

Set id: 57010aec-bffb-4737-a1f0-164b0afe3f52

Version: 2

Effective Time: 20150609

L.N.K. International, Inc.