SLEEP AID- diphenhydramine hcl, tablet
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 tablet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Use

Helps to reduce difficulty falling asleep.

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
glaucoma
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 (1-800-222-1222).

Directions

adults and children 12 years of age and over: take 2 tablets at bedtime if needed or as directed by a doctor

Other information

each tablet contains: calcium 65 mg
store at 15º-30ºC (59º-86ºF)

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose

Questions or comments?

Call toll free 1-800-842-7886

Principal Display Panel

Compare to the active ingredient of Sominex® Tablets*

nighttime sleep-aid

Diphenhydramine HCl, 25 mg

wake up rested and refreshed

TABLETS

*This product is not manufactured or distributed by Prestige Brands, Inc., owner of the registered trademark Sominex®.

Distributed by: Kmart Corporation, Hoffman Estates, IL 60179 Shop Kmart.com

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Package Label

Smart Sense Nighttime Sleep-Aid

SLEEP AID
diphenhydramine hcl, tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49738-252
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ALUMINUM OXIDE (UNII: LMI26O6933)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	BLUE	Score	2 pieces
Shape	ROUND	Size	10mm
Flavor		Imprint Code	10081008
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49738-252-10	1 in 1 BOX	03/31/2014	12/31/2020
1		100 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	part338	03/31/2014	12/31/2020

Labeler - SMART SENSE (Kmart) (008965873)

Revised: 8/2019

Document Id: c8fc6c21-1e45-43ae-911b-83eebf7326fb

Set id: 37494b83-4fc5-4b7b-b05d-d1e2b4574042

Version: 3

Effective Time: 20190808

SMART SENSE (Kmart)