Acetaminophen and Phenylephrine HCl
Drug Details
- Generic Name
- Acetaminophen and Phenylephrine HCl
- Brand Names
- Sinus and Headache, Sinus Headache PEMaximum Strength Non-Drowsy Maximum Strength Non-Drowsy, SINUS PAIN AND CONGESTION DAYTIME, Sinus Congestion and Pain Daytime, Sinus Congestion and Pain Relief Non-Drowsy, Daytime, Sinus Pressure and Pain PE Maximum Strength
- Application Number
- M012
- Sponsor
- Cardinal Health 110, LLC. DBA Leader
- NDC Codes
- 6
- Dosage Forms
- TABLET, FILM COATED, TABLET, TABLET, COATED
- Routes
- ORAL
- Active Ingredients
- ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
Indications and Usage
Uses temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold: sinus congestion and pressure headache minor aches and pains nasal congestion promotes sinus drainage temporarily reduces fever
Warnings
Warnings Liver warning/Allergy alert Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000mg of acetaminophen in 24 hours with other drugs containing acetminophen 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. 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 using 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 Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product When using this product do not exceed recommended dose Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain 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 You may report side effects to 1-888-952-0050 If pregnant or breast-feeding If pregnant or breast-feeding, ask a health professional before use.