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SUDAFED PE® Head Congestion + Flu Severe Relief Decongestant Tablets with Acetaminophen*

These non-drowsy congestion, cold, and flu medicine tablets provide relief from your symptoms, including cough, sinus pressure, sinus congestion, sinus headache, sore throat and head and chest congestion.

*On November 8, 2024 the U.S. Food & Drug Administration (FDA) issued a proposed order to remove oral phenylephrine (PE) from the OTC monograph. The FDA proposed order is not related to safety.

Product Details

SUDAFED® PE Head Congestion + Flu Severe Tablets provide effective relief for cold and flu symptoms, including sinus pressure, headache, sore throat, cough, fever, and head and chest congestion. Each non-drowsy caplet contains 325mg of acetaminophen (pain reliever and fever reducer), 5mg of phenylephrine HCl (nasal decongestant), 100mg of guaifenesin (expectorant), and 10mg of dextromethorphan HBr (cough suppressant). These tablets offer temporary relief from various cold and flu related symptoms and help loosen phlegm and thin bronchial secretions.

From the #1 pharmacist recommended brand among oral OTC decongestants, these non-drowsy cold and flu medicine tablets are suitable for adults and children aged 12 and over.

  • These cold and flu relief medicine tablets temporarily relieve these symptoms due to the common cold:

    • Nasal congestion

    • Headache

    • Minor aches and pains

    • Cough

    • Sore throat

  • Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive

  • Temporarily reduces fever

Active Ingredients:

  • Acetaminophen 325 mg - Pain reliever/fever reducer

  • Dextromethorphan HBr 10 mg - Cough suppressant

  • Guaifenesin 100 mg - Expectorant

  • Phenylephrine HCl 5 mg - Nasal decongestant

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

Do not use more than directed

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

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.

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)

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, 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.

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.

  • Store between 20-25°C (68-77°F)

  • Contains FD&C yellow no. 5 aluminum lake (tartrazine) as a color additive

Questions or comments?

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

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