Drug Facts
Composition & Profile
Identifiers & Packaging
PRINCIPAL DISPLAY PANEL 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
- PRINCIPAL DISPLAY PANEL 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
Overview
Uses 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
Indications & Usage
Uses 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
Dosage & Administration
Directions 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
Warnings & Precautions
Warnings 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.
Purpose
Active ingredients (in each tablet) Purposes Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Guaifenesin 100 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant
Do Not Use
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
When Using
When using this product do not exceed recommended dose
Stop Use & Ask a Doctor
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.
Keep Out of Reach of Children
Keep out of reach of children.
Storage & Handling
Other information 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
Questions
Questions or comments? call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)
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