SMART SENSE ALLERGY- diphenhydramine hydrochloride tablet 
Kmart Corporation

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.

----------

Kmart Corporation Allergy Tablets Drug Facts

Active ingredient (in each tablet)

Diphenhydramine hydrochloride 25 mg

Purpose

Antihistamine

Uses

•
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
•
runny nose
•
sneezing
•
itchy, watery eyes
•
itchy nose or throat
•
temporarily relieves these symptoms of the common cold:
•
runny nose
•
sneezing

Warnings

Do not use

•
with any other product containing diphenhydramine, even one used on skin
•
to make a child sleepy

Ask a doctor before use if you have

•
glaucoma
•
trouble urinating due to an enlarged prostate gland
•
a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

•
marked drowsiness may occur
•
avoid alcoholic drinks
•
excitability may occur, especially in children
•
alcohol, sedatives and tranquilizers may increase drowsiness
•
be careful when driving a motor vehicle or operating machinery

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

•
take every 4 to 6 hours, not more than 6 doses in 24 hours

adults and children 12 years of age and over

1 or 2 tablets

children 6 to under 12 years of age

1 tablet

children 4 to under 6 years of age

do not use unless directed by a doctor

children under 4 years of age

do not use

Other information

•
each tablet contains: calcium 20 mg
•
store at 20°-25°C

Inactive ingredients

carnauba wax, crospovidone, D&C red no. 27 aluminum lake, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, starch, stearic acid, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the active ingredient of Benadryl® Allergy Ultratab® Tablets

ALLERGY TABLETS

Diphenhydramine HCl - Antihistamine

For Allergy Relief

Sneezing, Runny Nose, Itchy, Watery Eyes, Itchy Throat

EASY TO SWALLOW

GLUTEN FREE

SEE NEW WARNING AND DOSING DIRECTIONS

Allergy Tablets Carton Image 1

Allergy Tablets Carton Image 1

Allergy Tablets Carton Image 2

Allergy Tablets Carton Image 1

Allergy Tablets Carton Image 2

SMART SENSE ALLERGY 
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49738-479
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
Product Characteristics
ColorPINK (dark) Scoreno score
ShapeCAPSULESize10mm
FlavorImprint Code L479
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49738-479-781 in 1 CARTON03/03/201106/07/2016
1100 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:49738-479-79400 in 1 BOTTLE; Type 0: Not a Combination Product01/06/201103/03/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/06/201106/07/2016
Labeler - Kmart Corporation (008965873)

Revised: 12/2018
Document Id: f0117bd4-e52a-4a9c-a3c2-cbc34e3ac952
Set id: c2c6f4cc-c190-4cda-8b67-2951e07e75d5
Version: 2
Effective Time: 20181226
 
Kmart Corporation