SUPHEDRINE PE- phenylephrine hydrochloride tablet, coated 
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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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1131-DDM-2021-1126

Drug Facts

Active ingredient (in each tablet)

Phenylephrine HCl 10 mg

Purpose

Nasal decongestant

Uses

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.

Directions

Other information

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C red #27, FD&C red #40, FD&C yellow #6, hypromellose, lactose anhydrous, magnesium stearate, polyethylene glycol, stearic acid, titanium dioxide

PRINCIPAL DISPLAY PANEL

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†Compare to the Active Ingredient in Sudafed PE® Congestion

maximum strength

CONGESTION

SUPHEDRINE PE

Nasal Decongestant

Relieves:

• PHENYLEPHRINE HCl

Sinus Pressure & Congestion

NON-DROSWSY

36 TABLETS

10 mg each

image description

SUPHEDRINE PE 
phenylephrine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-131
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorredScoreno score
ShapeROUNDSize7mm
FlavorImprint Code A;131
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53943-131-021 in 1 CARTON12/06/2011
118 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:53943-131-032 in 1 CARTON12/06/2011
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 finalpart34112/06/2011
Labeler - DISCOUNT DRUG MART (047741335)

Revised: 11/2021
Document Id: d20273fd-f7d2-3c31-e053-2a95a90a3868
Set id: a7897caf-6adf-4459-b324-3504960e9677
Version: 2
Effective Time: 20211130
 
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