Sudafed PE Pressure plus Pain plus Cough Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride CARNAUBA WAX HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POWDERED CELLULOSE SODIUM STARCH GLYCOLATE TYPE A ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE Off-white SU;PE;SU;06
Drug Facts
Composition & Profile
Identifiers & Packaging
PRINCIPAL DISPLAY PANEL See New Warning SINUS NDC 50580-550-24 SUDAFED PE® PRESSURE + PAIN + COUGH For Adults Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr Pain Reliever/Fever Reducer, Nasal Decongestant, Cough Suppressant SINUS PRESSURE + CONGESTION SINUS HEADACHE SORE THROAT COUGH NON-DROWSY 24 CAPLETS ‡ Actual Pill Size PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL See New Warning SINUS NDC 50580-550-24 SUDAFED PE® PRESSURE + PAIN + COUGH For Adults Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr Pain Reliever/Fever Reducer, Nasal Decongestant, Cough Suppressant SINUS PRESSURE + CONGESTION SINUS HEADACHE SORE THROAT COUGH NON-DROWSY 24 CAPLETS ‡ Actual Pill Size PRINCIPAL DISPLAY PANEL
Overview
Uses temporarily relieves these common cold/flu symptoms: sinus congestion and pressure nasal congestion cough sore throat minor aches and pains headache promotes nasal and sinus drainage temporarily reduces fever
Indications & Usage
Uses temporarily relieves these common cold/flu symptoms: sinus congestion and pressure nasal congestion cough sore throat minor aches and pains headache promotes nasal and sinus drainage temporarily reduces fever
Dosage & Administration
Directions 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
Warnings & Precautions
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 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 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, 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. 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 caplet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant 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, 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.
Keep Out of Reach of Children
Keep out of reach of children.
Storage & Handling
Other information store between 20-25°C (68-77°F) do not use if carton is opened or if blister unit is broken
Questions
Questions or comments? call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)
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