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)