SMART SENSE ALLERGY RELIEF- diphenhydramine hydrochloride tablet

smart sense Allergy Relief by

Drug Labeling and Warnings

smart sense Allergy Relief by is a Otc medication manufactured, distributed, or labeled by Kmart Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Diphenhydramine HCl 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 (1-800-222-1222).

Directions

• take every 4 to 6 hours, or as directed by a doctor
• do not take more than 6 doses in 24 hours

• adults and children 12 years and over:

  1 to 2 tablets

• children 6 to under 12 years:

  1 tablet

• children under 6 years:

  do not use

Other information

• each tablet contains: calcium 20 mg
• store at 20-25°C (68-77°F). Avoid high humidity. Protect from light.
• do not use if blister unit is broken or torn

Inactive ingredients

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

Questions or comments?

1-800-719-9260

Principal Display Panel

COMPARE TO ACTIVE INGREDIENT IN BENADRYL® ALLERGY ULTRATAB®

ACTUAL SIZE

multi-symptom

allergy relief

DIPHENHYDRAMINE HCl 25 mg

ANTIHISTAMINE

RELIEVES:

SNEEZING

ITCHY, WATERY EYES

RUNNY NOSE – ITCHY THROAT

24 TABLETS

INGREDIENTS AND APPEARANCE

SMART SENSE ALLERGY RELIEF 
diphenhydramine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49738-695
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
D&C RED NO. 27 (UNII: 2LRS185U6K)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (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
Color	PINK (dark)	Score	no score
Shape	CAPSULE	Size	10mm
Flavor		Imprint Code	L479
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49738-695-78	1 in 1 CARTON	02/20/2014
1		100 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 49738-695-79	400 in 1 BOTTLE; Type 0: Not a Combination Product	02/20/2014
3	NDC: 49738-695-62	24 in 1 CARTON	02/20/2014
3		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/20/2014

Labeler - Kmart Corporation (008965873)