Nighttime Sleep-Aid by SMART SENSE (Kmart) / P & L Development, LLC DRUG FACTS

Drug Details [pdf]

NIGHTTIME SLEEP-AID MAXIMUM STRENGTH- diphenhydramine hcl capsule
SMART SENSE (Kmart)

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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DRUG FACTS

Active ingredient (in each softgel)

Diphenhydramine HCl 50 mg

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 before use if you have

emphysema
chronic bronchitis
glaucoma
difficulty in urination due to an enlargement of the prostate gland

Ask a doctor or pharmacist before use

if you are now taking sedatives or tranquilizers.

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.

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. (1-800-222-1222)

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)

Inactive ingredients

edible white ink, FD&C Blue #1, gelatin, glycerin, polyethylene glycol, purified water and sorbitol special

Questions or comments?

Call toll free 1-800-842-7886

Principal Display Panel

Compare to Maximum Strength Unisom® SleepGels® active ingredient*

NIGHTTIME SLEEP-AID

Maximum Strength

Sleep-Aid

Diphenhydramine HCl 50 mg

Helps To Reduce Difficulty Falling Asleep

SOFTGELS

Distributed by: Kmart Corporation

Hoffman Estates, IL 60179

Shop kmart.com

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

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 Maximum Strength Unisom® SleepGels®.

Product Label

Smart Sense Maximum Strength Sleep-Aid

NIGHTTIME SLEEP-AID MAXIMUM STRENGTH
diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49738-230
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)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	BLUE	Score	no score
Shape	CAPSULE	Size	13mm
Flavor		Imprint Code	P50;A99
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 49738-230-64	1 in 1 BOX	03/31/2013	12/31/2019
1		64 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	03/31/2013	12/31/2019

Labeler - SMART SENSE (Kmart) (008965873)

Registrant - P & L Development, LLC (800014821)

Revised: 12/2018

Document Id: 22f55264-cec3-4ddb-bef5-ab614297437d

Set id: 5ced2ba5-4a79-4b9b-b949-5c0bcec9cdaa

Version: 4

Effective Time: 20181226