Sudafed PE Pressure Plus Pain Plus Cold

McNeil Consumer Healthcare Div. McNeil-PPC, Inc

Sudafed Pressure + Pain + Cold

FULL PRESCRIBING INFORMATION: CONTENTS*

• Sudafed PE Pressure Plus Pain Plus Cold Uses
• Warnings
  • Liver warning
  • Sore throat warning
  • Do not use
  • Ask a doctor before use if you have
  • Stop use and ask a doctor if
  • Overdose warning
• Directions
• Sudafed PE Pressure Plus Pain Plus Cold Other information
• Inactive ingredients
• Questions or comments?
• PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Sudafed PE Pressure Plus Pain Plus Cold Uses

• temporarily relieves 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

Warnings

Liver warning

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

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.

Directions

• do not use more than directed (see overdose warning)

Sudafed PE Pressure Plus Pain Plus Cold Other information

• each caplet contains: sodium 3 mg
• 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

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

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

See New Warnings
Information & Directions

SINUS

NDC 50580-679-25

SUDAFEED^{PE ®}

PRESSURE + PAIN + COLD
For
Adults

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

SINUS PRESSURE
+ CONGESTION

SINUS HEADACHE

SORE THROAT

CHEST CONGESTION

COUGH

NON-DROWSY

24 CAPLETS

‡ Actual Pill Size