Head Congestion Plus Flu Severe Pe Tablet, Coated
FDA Label NDC 72476-174

Drug Facts

• 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 caplets (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

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.

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 dosage

• nervousness, dizziness, or sleeplessness occur
• pain, nasal congestion, or cough 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 take more than directed (see overdose warning)

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

• store between 20-25°C (68-77°F) in a dry place
• retain carton for complete product information and warnings

colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

Careone®

NDC 72476-174-02

Compare to the active ingredients in Sudafed PE® Head Congestion + Flu Severe

HEAD CONGESTION + FLU SEVERE PE

Pain Reliever / Fever Reducer - Acetaminophen

Cough suppressant - Dextromethorphan HBr

Expectorant - Guaifenesin

Nasal Decongestant - Phenylephrine HCl

For Relief of

Sinus Pressure      Headache

Sore Throat          Cough

Chest Congestion

24 CAPLETS

Actual Size

Image Description (F117402car R2)