Kmart Corporation Nasal Decongestant PE Drug Facts

Smart Sense nasal decongestant pe by

Drug Labeling and Warnings

Smart Sense nasal decongestant pe by is a Otc medication manufactured, distributed, or labeled by Kmart Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SMART SENSE NASAL DECONGESTANT PE MAXIMUM STRENGTH- phenylephrine 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 Nasal Decongestant PE Drug Facts

Active ingredient (in each tablet)

Phenylephrine HCl 10 mg

Purpose

Nasal decongestant

Uses

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

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

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

When using this product

do not use more than directed

Stop use and ask a doctor if

• you get nervous, dizzy or sleepless
• symptoms do not improve within 7 days or are accompanied by 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

• adults and children 12 years and over:
  • take 1 tablet every 4 hours
  • do not take more than 6 tablets in 24 hours
• children under 12 years:

  do not use this product in children under 12 years of age

Other information

• store at 20º-25ºC (68º-77ºF)

Inactive ingredients

anhydrous dibasic calcium phosphate, carnauba wax, FD&C red no. 40 aluminum lake, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the active ingredient of Non-Drowsy Sudafed PE® Maximum Strength Nasal Decongestant Tablets

Non-Drowsy

DECONGESTANT

Maximum Strength

Nasal Decongestant PE

Phenylephrine Hydrochloride 10mg

RELIEVES:

Nasal & Sinus Congestion

Sinus Pressure

18 TABLETS

1 PILL/DOSE

SMART SENSE NASAL DECONGESTANT PE  MAXIMUM STRENGTH
phenylephrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49738-094
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL (UNII: 532B59J990)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	RED	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	L7
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49738-094-23	72 in 1 CARTON	12/29/2010	04/30/2019
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 49738-094-89	18 in 1 CARTON	12/29/2010	08/15/2019
2		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	12/29/2010	08/15/2019

Labeler - Kmart Corporation (008965873)

Revised: 12/2019

Document Id: ddae6949-7824-4488-91ba-942f6ef0984c

34390-5

Set id: c788ca3f-2ce1-4729-aadf-d791cb692d11

Version: 3

Effective Time: 20191216