Allergy Relief by SMART SENSE (Kmart) DRUG FACTS

Drug Details [pdf]

ALLERGY RELIEF ANTIHISTAMINE- diphenhydramine hcl capsule, liquid filled
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)

Purpose

Diphenhydramine

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 15°-30°C (59º-86ºF)

Inactive ingredients

croscarmellose sodium, dicalcium phospate, 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 in Benadryl® Allergy Liqui-Gels®*

Dye- Free

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Benadryl®, or Catalent Pharma solutions, Inc., owner of the registered trademark Liqui-Gels®.

ALLERGY

Allergy Relief

Diphenhydramine HCl 25 mg/ Antihistamine

Relieves:

sneezing
itchy, watery eyes
runny nose
itchy nose or throat

Softgels**

(**Liquid-Filled Capsules)

Dye-Free

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

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

Distributed by:

Kmart Corporation

Hoffman Estates, IL 60179

Shop kmart.com

Product of Canada

Product Label

Diphenhydramine HCl 25 mg softgels

ALLERGY RELIEF ANTIHISTAMINE
diphenhydramine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49738-970
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
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	WHITE, YELLOW	Score	no score
Shape	CAPSULE	Size	15mm
Flavor		Imprint Code	A33
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 49738-970-24	2 in 1 CARTON	04/01/2013	04/01/2020
1		12 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	04/01/2013	04/01/2020

Labeler - SMART SENSE (Kmart) (008965873)

Revised: 6/2019

Document Id: 13ba6761-d16d-4f56-91fb-1e6c4116dad8

Set id: a1c5aa58-584f-4eed-9754-e3d78765d3b3

Version: 2

Effective Time: 20190625

SMART SENSE (Kmart)