SUDAFED PE Pressure PLUS Pain PLUS Mucus

Dosage form: tablet, film coated
Ingredients: Acetaminophen 325mg, Guaifenesin 200mg, Phenylephrine hydrochloride 5mg
Labeler: McNeil Consumer Healthcare Div. McNeil-PPC, Inc
NDC Code: 50580-680

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.

SUDAFED PE®
PRESSURE + PAIN + MUCUS For Adults

Drug Facts

Active ingredients (in each caplet)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant

Uses
  • temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:
    • sinus congestion and pressure
    • headache
    • minor aches and pains
    • nasal congestion
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily reduces fever

Warnings

Liver warning

This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (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

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
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)

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, nasal congestion or cough 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
  • cough comes back or occurs with rash or headache that lasts

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
  • do not take more than directed (see overdose warning)
adults and children 12 years and over
  • take 2 caplets every 4 hours
  • do not take more than 10 caplets in 24 hours
children under 12 yearsask a doctor

Other information
  • each caplet contains: sodium 3 mg
  • store between 20-25°C (68-77°F)
  • do not use if carton is opened or if blister unit is broken

Inactive ingredients

carnauba wax, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide, triacetin

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

See New Warnings
Information & Directions

SINUS

NDC 50580-680-25

SUDAFED PE®
PRESSURE+PAIN + MUCUS
For
Adults

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

SINUS PRESSURE
+ CONGESTION

SINUS HEADACHE

CHEST
CONGESTION

FORMERLY NAMED
SUDAFED PE® Triple Action®

NON-DROWSY

24 CAPLETS

‡ Actual Pill Size

SUDAFED PE PRESSURE PLUS PAIN PLUS MUCUS 
acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-680
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (acetaminophen) Acetaminophen325 mg
Guaifenesin (guaifenesin) Guaifenesin200 mg
Phenylephrine hydrochloride (phenylephrine) Phenylephrine hydrochloride5 mg
Inactive Ingredients
Ingredient NameStrength
carnauba wax 
croscarmellose sodium 
hydroxypropyl cellulose (type e) 
hypromelloses 
magnesium stearate 
cellulose, microcrystalline 
titanium dioxide 
triacetin 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize20mm
FlavorImprint CodeSU;PE;SU;02
Contains    
Packaging
#Item CodePackage Description
1NDC:50580-680-252 BLISTER PACK in 1 CARTON
112 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/01/2013
Labeler - McNeil Consumer Healthcare Div. McNeil-PPC, Inc (878046358)

Revised: 10/2012
 
McNeil Consumer Healthcare Div. McNeil-PPC, Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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