Sudafed Pe Head Congestion Plus Flu Severe Tablet, Film Coated
FDA Label NDC 50580-450

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.

• 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

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

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.

• 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

• 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

• 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.

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.

• 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 years	ask a doctor

• 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

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

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

PREVIOUSLY SUDAFED PE^® PRESSURE + PAIN + COLD
NDC 50580-450-01

SUDAFED^PE®

HEAD CONGESTION
+ FLU SEVERE

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

actual
size

• SINUS PRESSURE
• HEADACHE
• SORE THROAT
• COUGH
• CHEST CONGESTION

24 TABLETS

NON-DROWSY



Principal Display Panel (Sudafed 01)