Acetaminophen and Phenylephrine HCl
Drug Details
- Generic Name
- Acetaminophen and Phenylephrine HCl
- Brand Names
- Sinus Pressure and Pain PE Maximum Strength, Sinus Congestion and Pain Relief Non-Drowsy, Daytime, Sinus and Headache, Sinus Headache PEMaximum Strength Non-Drowsy Maximum Strength Non-Drowsy, SINUS PAIN AND CONGESTION DAYTIME, Sinus Congestion and Pain Daytime
- Application Number
- M012
- Sponsor
- Rite Aid Corporation
- NDC Codes
- 6
- Dosage Forms
- TABLET, TABLET, COATED, TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
Indications and Usage
Uses temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold: minor aches and pains headache nasal congestion sinus congestion and pressure helps decongest sinus openings and passages promotes sinus drainage helps clear nasal passages temporarily reduces fever
Warnings
Warnings Liver warning: This product contains acetaminophen. 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: blisters rash skin reddening 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 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 high blood pressure thyroid disease liver disease diabetes heart disease difficulty in urination due to enlargement of the prostate gland 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. 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 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 accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.