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SUDAFED PE® Head Congestion + Pain Relief Decongestant Caplets with Ibuprofen*

This non-drowsy nasal decongestant helps provide head congestion, sinus pressure and sinus headache relief, while also reducing and pain and fever. Each coated caplet contains ibuprofen and phenylephrine HCl for powerful cold & flu symptom relief.

*In September, 2023, The Nonprescription Drugs Advisory Committee of the Food and Drug Administration reviewed efficacy data available for orally administered phenylephrine (PE) as a nasal decongestant. Read the FDA’s statement about this review here.

Product Details

SUDAFED PE® Head Congestion + Pain provides maximum strength congestion relief, plus the powerful pain relief of Ibuprofen to help relieve multiple cold and flu-related symptoms. Each coated caplet contains 200mg of the NSAID Ibuprofen to reduce fever, headache, and body aches and pains. Each tablet also contains 10 mg of phenylephrine HCl to help relieve head and nasal congestion, sinus pressure, sinus headache and other symptoms by reducing swelling of nasal passages.

From the #1 pharmacist recommended brand among oral OTC decongestants, this non-drowsy decongestant is suitable for adults and children ages 12+.

Temporarily relieves these symptoms associated with the common cold or flu:

  • Headache

  • Fever

  • Sinus pressure

  • Nasal congestion

  • Minor body aches and pains

  • Reduces swelling of the nasal passages

  • Temporarily restores freer breathing through the nose

Active Ingredients:

  • Ibuprofen 200 mg (NSAID)* - Pain reliever/fever reducer

  • Phenylephrine HCl 10 mg - Nasal decongestant

Inactive Ingredients:

Colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, stearic acid, talc, titanium dioxide

*nonsteroidal pain-relieving drug

Do not take more than directed

Adults and children 12 years of age and over:

  • Take 1 caplet every 4 hours while symptoms persist

  • Do not use more than 6 caplets in any 24-hour period unless directed by a doctor

Children under 12 years of age:

  • Do not use because this product contains too much medication for children under this age

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

  • Hives

  • Facial swelling

  • Asthma (wheezing)

  • Shock

  • Skin reddening

  • Rash

  • Blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Ask a doctor before use if

  • Stomach bleeding warning applies to you

  • You have problems or serious side effects from taking pain relievers or fever reducers

  • You have a history of stomach problems, such as heartburn

  • You have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes, have trouble urinating due to an enlarged prostate gland, or had a stroke

  • You are taking a diuretic

  • Under a doctor’s care for any serious condition

  • Taking any other product that contains phenylephrine or any other nasal decongestant

  • Taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin

  • Taking any other drug

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

  • Are age 60 or older

  • Have had stomach ulcers or bleeding problems

  • Take a blood thinning (anticoagular) or steroid drug

  • Take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

  • Have 3 or more alcoholic drinks every day while using this product

  • Take more or for a longer time than directed

When using this product

  • Take with food or milk if upset stomach occurs

Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do not use

  • In children under 12 years of age because this product contains too much medication for children under this age

  • If you have ever had an allergic reaction to any other pain reliever/fever reducer

  • Right before or after heart surgery

  • 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 your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product

Stop use and ask a doctor if

You experience any of the following signs of stomach bleeding:

  • Feel faint

  • Vomit blood

  • Have bloody or black stools

  • Have stomach pain that does not get better

  • You have symptoms of heart problems or stroke:

    • Chest pain

    • Trouble breathing

    • Weakness in one part of side of body

    • Slurred speech

    • Leg swelling

  • Pain gets worse or lasts more than 7 days

  • Fever gets worse or lasts more than 3 days

  • Nasal congestion lasts for more than 7 days

  • Symptoms continue or get worse

  • Redness or swelling is present in the painful area

  • You get nervous, dizzy, or sleepless

  • Any new symptoms appear

If pregnant or breast-feeding

  • Ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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). Avoid excessive heat above 40 °C (104 °F)

Questions or comments?

Call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

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