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  5. Label Information: Sudafed Pe Head Congestion Plus Flu Severe

FDA Label for Sudafed Pe Head Congestion Plus Flu Severe

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. LIVER WARNING
    5. SORE THROAT WARNING
    6. DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. OTC - ASK DOCTOR/PHARMACIST
    9. OTC - WHEN USING
    10. STOP USE AND ASK A DOCTOR IF
    11. OTC - PREGNANCY OR BREAST FEEDING
    12. OTC - KEEP OUT OF REACH OF CHILDREN
    13. OVERDOSE WARNING
    14. DIRECTIONS
    15. OTHER INFORMATION
    16. INACTIVE INGREDIENTS
    17. QUESTIONS OR COMMENTS?
    18. PRINCIPAL DISPLAY PANEL

Sudafed Pe Head Congestion Plus Flu Severe Product Label

The following document was submitted to the FDA by the labeler of this product Johnson & Johnson Consumer Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

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.


Otc - Purpose



Active ingredients (in each tablet)Purposes
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Guaifenesin 100 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant

Uses



  • temporarily relieves these symptoms due to the common cold:
    • nasal congestion
    • headache
    • minor aches and pains
    • cough
    • sore throat
    • sinus congestion and pressure
    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
    • temporarily reduces fever

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

Sore Throat Warning



If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.


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)

Otc - Ask Doctor/Pharmacist



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


Otc - When Using



When using this product do not exceed recommended dose


Stop Use And Ask A Doctor If



  • nervousness, dizziness, or sleeplessness occur
  • pain, cough 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
  • cough comes back or occurs with rash or headache that lasts

    • These could be signs of a serious condition.


Otc - Pregnancy Or Breast Feeding



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


Otc - Keep Out Of Reach Of Children



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 use more than directed (see overdose warning)
    • 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



  • contains FD&C yellow no. 5 aluminum lake (tartrazine) as a color additive
  • store between 20-25°C (68-77°F)
  • do not use if carton or blister unit is opened or broken

Inactive Ingredients



carnauba wax, croscarmellose sodium, FD&C yellow no. 5 aluminum lake (tartrazine), FD&C yellow no. 6 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, 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 + COLD
NDC 50580-450-01

SUDAFEDPE®

HEAD CONGESTION
+ FLU SEVERE

Acetaminophen, Dextromethorphan HBr, Guaifenesin,
Phenylephrine HCl, Pain Reliever/Fever Reducer,
Cough Suppressant, Expectorant, Nasal Decongestant

actual
size

* Please review the disclaimer below.