Drug Facts

Drug Facts

Drug Labeling and Warnings

Drug Details

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NASAL DECONGESTANT PE MAXIMUM STRENGTH NON-DROWSY- phenylephrine 10 mg tablet 
Allegiant 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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Drug Facts

Active ingredient

Phenylephrine HCl 10 mg

Purpose

Nasal Decongestant

Uses

temporarily relieves:

  • nasal congestion due to the common cold, hay fever, or other upper respiratory allergies
  • nasal congestion associated with sinusitis 
  • sinus congestion and pressure

Warnings

Do not use

Do not use if you are now taking a prescription mono-amine 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

Keep Out of Reach of Children

In case of accidentaloverdose, contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • Adults and children 12 years of age and older: 
  • 1 tablet every 4 to 6 hours. 
  • Do not take more than 6 tablets in 24 hours
  • Children under 12 years of age: ask a doctor

Inactive Ingredients

croscarmellose sodium, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide

If pregnant or breast-feeding,

If pregnant or breast-feeding, ask a health professionalbefore use.

Principal Display Panel

Phenylephrine HCl 10mg

Phenylephrine HCl 10mg


NASAL DECONGESTANT PE  MAXIMUM STRENGTH NON-DROWSY
phenylephrine 10 mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69168-272
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize8mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69168-272-931 in 1 CARTON12/23/2014
124 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/23/2014
Labeler - Allegiant Health (079501930)

Revised: 11/2018
 
Allegiant Health


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