SUNMARK NASAL DECONGESTANT PE MAXIMUM STRENGTH- phenylephrine hydrochloride tablet, film coated 
Strategic Sourcing Services LLC

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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McKesson Nasal Decongestant PE Drug Facts

Active ingredient (in each tablet)

Phenylephrine HCI 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
diabetes
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

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 20-25°C (68-77°F)
do not use if blister unit is broken or torn

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 SUDAFED PE® CONGESTION

ACTIVE INGREDIENT

nasal decongestant PE

Maximum Strength

Phenylephrine HCl Tablets, 10 mg

Nasal & sinus congestion - Sinus pressure

36 doses - 1 pill/dose

GLUTEN FREE

NON-DROWSY

Actual Size

36 TABLETS 10 mg EACH

nasal decongestant pe image
SUNMARK NASAL DECONGESTANT PE  MAXIMUM STRENGTH
phenylephrine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-700
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize8mm
FlavorImprint Code L7
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49348-700-481 in 1 CARTON02/14/2005
118 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:49348-700-072 in 1 CARTON02/14/2005
218 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/14/2005
Labeler - Strategic Sourcing Services LLC (116956644)

Revised: 1/2021
Document Id: 06a40e28-bd73-4556-a977-787747522d59
Set id: 140dec71-7933-4d38-870a-9233061222c8
Version: 5
Effective Time: 20210104
 
Strategic Sourcing Services LLC