SUDAFED PE SINUS PRESSURE PLUS PAIN- acetaminophen and phenylephrine hydrochloride tablet, film coated 
Kenvue Brands LLC

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Sudafed PE Sinus Pressure Plus Pain

Drug Facts

Active ingredients (in each tablet)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Phenylephrine HCl 5 mgNasal decongestant

Uses

Warnings

Liver warning

This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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.
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

When using this product do not exceed recommended dose

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • pain or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur

These could be signs of a serious condition.

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

Keep out of reach of children.

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

adults and children 12 years and over
  • take 2 tablets every 4 hours
  • do not take more than 10 tablets in 24 hours
children under 12 yearsask a doctor

Other information

Inactive ingredients

carnauba wax, FD&C yellow no. 6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, modified starch, polyethylene glycol, polysorbate 80, powdered cellulose, pregelatinized starch, sodium starch glycolate, titanium dioxide

Questions or comments?

call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

PREVIOUSLY SUDAFED PE ® PRESSURE + PAIN
NDC 50580-435-01

SUDAFED PE®

SINUS
PRESSURE + PAIN

Acetaminophen, Phenylephrine HCl
Pain Reliever/Fever Reducer, Nasal Decongestant

actual size

MAXIMUM STRENGTH

24 TABLETS

NON-DROWSY

PRINCIPAL DISPLAY PANEL
SUDAFED PE SINUS PRESSURE PLUS PAIN 
acetaminophen and phenylephrine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-435
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
Product Characteristics
Colororange (PEACH) Scoreno score
ShapeOVALSize18mm
FlavorImprint Code SUPE;WL89
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-435-012 in 1 CARTON06/17/2019
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01206/17/2019
Labeler - Kenvue Brands LLC (118772437)

Revised: 11/2024
Document Id: 21acd6b1-eb94-3ebb-e063-6294a90a9578
Set id: 60183922-bfd3-4377-884a-51b2f0a4c93a
Version: 6
Effective Time: 20241108
 
Kenvue Brands LLC