This SUDAFED® product is currently unavailable.
Sign up to be notified when it’s available.
SUDAFED PE® Severe Cold
Use Only as Directed
Behind the Counter
If you’re outside of Mississippi and Oregon, this SUDAFED® product is kept behind the pharmacy or sales counter, but no prescription is needed.See why »
In Mississippi and Oregon, a prescription is required to purchase this SUDAFED® product.See why »
Get multi-symptom cold relief of sinus and nasal congestion, cough, fever, sore throat, and runny nose.
- Available in a box of 24
- New look, same effective relief you trust
- temporarily relieves these symptoms of the common cold:
- runny nose
- minor aches and pains
- nasal congestion
- sore throat
- temporarily relieves sinus congestion and pressure
This website contains the most current Drug Facts labeling information and may differ from labels on product packaging you may have. If there are any differences between this website labeling and product package labeling, this website labeling should be regarded as the most current.
do not use more than directed (see overdose warning)
adults and children 12 years and over
- take 2 caplets every 4 hours
- do not take more than 12 caplets in 24 hours
children under 12 years
- do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
|Active Ingredient (in each tablet)||Purpose|
|Acetaminophen 325 mg||Pain reliever/fever reducer|
|Diphenhydramine HCl 12.5 mg||Antihistamine/cough suppressant|
|Phenylephrine HCl 5 mg||Nasal decongestant|
carnauba wax, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium citrate, sodium starch glycolate, talc, titanium dioxide
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 12 caplets in 24 hours, which is the maximum daily amount
- 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
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- a breathing problem such as emphysema or chronic bronchitis
Ask a doctor or pharmacist before you use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- do not exceed recommended dose.
- excitability may occur, especially in children
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
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: Taking more than the recommended dose (overdose) may cause liver damage. 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.