HEALTH MART MAXIMUM STRENGTH SLEEP AID- diphenhydramine hydrochloride capsule, liquid filled
Strategic Sourcing Services LLC

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.

----------

Health Mart Pharmacy Nighttime Sleep Aid

Active Ingredient (in each softgel)

Diphenhydramine HCl 50mg

Purpose

Nighttime sleep aid

Use

helps to reduce difficulty falling asleep

Warnings

Do not give to children under 12 years of age

Do not use this product

with other products containing diphenhydramine, even one used on skin.

Ask a doctor or pharmacist before use if you have

emphysema

chronic bronchitis

glaucoma

difficulty in urination due to an enlargement of the prostate gland

When using this product

avoid alcoholic beverages.

Stop use and ask a doctor if

sleeplessness persists for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

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 of age and over: take 1 softgel at bedtime if needed or as
directed by a doctor

Other Information

store at controlled room temperature 15°-30°C (59°-86°F)
do not use if imprinted safety seal under cap is broken or missing

Inactive ingredient

edible white ink, FDandC Blue #1, gelatin, glycerin, polyethylene glycol, purified water and sorbitol special.

Questions or comments?

Call toll free: 1-877-753-3935

Distributed by:
PL Developments
Westbury, NY 11590, USA

All Leader Brand Products are 100% satisfation guaranteed or return to place of purchase for a full refund

Principal Display Panel

*Compare to the active ingredient in Maximum Strength Unisom® SleepGels®

NDC 62011-0006-1

Maximum Strength Nighttime Sleep Aid

Diphenhydramine HCl

50mg EACH

Helps to reduce difficulty falling asleep

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Container Label

HEALTH MART MAXIMUM STRENGTH SLEEP AID
diphenhydramine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62011-0006
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 (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	BLUE (BLUE)	Score	no score
Shape	OVAL (OVAL)	Size	8mm
Flavor		Imprint Code	P50;A99
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62011-0006-1	1 in 1 BOX	04/06/2012	10/01/2019
1		32 in 1 BOX; 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	04/06/2012	10/01/2019

Labeler - Strategic Sourcing Services LLC (116956644)

Revised: 9/2019

Document Id: a61ef366-1267-48f1-91b4-1ce3f0bc8c44

Set id: ddd96561-2695-4694-9987-b38f83dac893

Version: 3

Effective Time: 20190918

Strategic Sourcing Services LLC