Kmart Corporation 12 Hour Decongestant Drug Facts

smart sense 12 hour decongestant by

Drug Labeling and Warnings

smart sense 12 hour decongestant by is a Otc medication manufactured, distributed, or labeled by Kmart Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SMART SENSE 12 HOUR DECONGESTANT- pseudoephedrine hydrochloride tablet, film coated, extended release 
Kmart Corporation

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Kmart Corporation 12 Hour Decongestant Drug Facts

Active ingredient (in each tablet)

Pseudoephedrine HCl 120 mg

Purpose

Nasal decongestant

Uses

• temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
• temporarily relieves sinus congestion and pressure

Warnings

Do not use

if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• high blood pressure
• heart disease
• diabetes
• thyroid disease
• trouble urinating due to an enlarged prostate gland

When using this product

do not exceed recommended dosage

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• symptoms do not improve within 7 days or occur with a fever

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

Other information

• each tablet contains: calcium 45 mg
• store at 20° - 25°C (68° - 77°F) in a dry place
• protect from light
• do not use if blister unit is broken or torn
• see carton end panel for lot number and expiration date
• this product meets the requirements of USP Drug Release Test 3

Inactive ingredients

carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the active ingredient of Sudafed® 12 Hour Caplets

Actual Size

MAXIMUM STRENGTH

12 HOUR DECONGESTANT

Pseudoephedrine Hydrochloride Extended Release Tablets, 120 mg

Long-Acting Nasal Decongestant

Sinus

Non-Drowsy

Pseudoephedrine HCl

Sinus Pressure - Congestion

120 mg EACH

GLUTEN FREE

*Capsule-Shaped Tablets

SMART SENSE 12 HOUR DECONGESTANT 
pseudoephedrine hydrochloride tablet, film coated, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49738-054
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	120 mg

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	L054
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49738-054-60	2 in 1 CARTON	03/14/2011	05/18/2018
1		10 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
ANDA	ANDA075153	03/14/2011	05/18/2018

Labeler - Kmart Corporation (008965873)

Revised: 12/2019

Document Id: 58540f3a-0fe7-400e-a82b-c64364015eb9

34390-5

Set id: da2f01ec-df18-48a9-8bc7-db6af1c637cc

Version: 3

Effective Time: 20191216

 

Kmart Corporation