Label: SUDAFED PE PRESSURE PLUS PAIN PLUS MUCUS- acetaminophen, guaifenesin and phenylephrine hydrochloride tablet, film coated

  • NDC Code(s): 50580-680-25
  • Packager: McNeil Consumer Healthcare Div. McNeil-PPC, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 10/12

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients (in each caplet) Purpose
    Acetaminophen 325 mg Pain reliever/fever reducer
    Guaifenesin 200 mg Expectorant
    Phenylephrine HCl 5 mg Nasal decongestant
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  • 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
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  • 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.

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  • Directions

    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 years ask a doctor
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  • 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
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  • Inactive ingredients

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

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  • Questions or comments?

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

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  • 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

    Principal Display Panel
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  • INGREDIENTS AND APPEARANCE
    SUDAFED PE PRESSURE PLUS PAIN PLUS MUCUS 
    acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50580-680
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Acetaminophen (acetaminophen) Acetaminophen 325 mg
    Guaifenesin (guaifenesin) Guaifenesin 200 mg
    Phenylephrine hydrochloride (phenylephrine) Phenylephrine hydrochloride 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    carnauba wax  
    croscarmellose sodium  
    hydroxypropyl cellulose (type e)  
    hypromelloses  
    magnesium stearate  
    cellulose, microcrystalline  
    titanium dioxide  
    triacetin  
    Product Characteristics
    Color WHITE Score no score
    Shape OVAL Size 20mm
    Flavor Imprint Code SU;PE;SU;02
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50580-680-25 2 in 1 CARTON
    1 12 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 07/01/2013
    Labeler - McNeil Consumer Healthcare Div. McNeil-PPC, Inc (878046358)
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