LEADER NASAL DECONGESTANT PE MAXIMUM STRENGTH- phenylephrine hydrochloride tablet 
Cardinal Health

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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Cardinal Health Nasal Decongestant PE Drug Facts

Active ingredient (in each tablet)

Phenylephrine hydrochloride 10 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

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

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

Other information

  • store at 20º-25ºC (68º-77ºF)

Inactive ingredients

carnauba wax, dibasic calcium phosphate, 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

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Compare to Non-Drowsy Sudafed PE® Maximum Strength active ingredient

Maximum Strength

Nasal Decongestant PE

Phenylephrine HCl Tablets – Nasal Decongestant

Non-Drowsy

Nasal & Sinus Congestion

Sinus Pressure

(10 mg each)

1 Pill/Dose

Nasal Decongestant PE Carton

Nasal Decongestant PE Carton

LEADER NASAL DECONGESTANT PE  MAXIMUM STRENGTH
phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:37205-473
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 
POLYVINYL ALCOHOL 
SILICON DIOXIDE 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize8mm
FlavorImprint Code L7
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-473-694 in 1 CARTON
118 in 1 BLISTER PACK
2NDC:37205-473-891 in 1 CARTON
218 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/04/2005
Labeler - Cardinal Health (097537435)

Revised: 7/2009
 
Cardinal Health