Acetaminophen and Phenylephrine HCl
Acetaminophen and Phenylephrine HCl is listed in the FDA National Drug Code directory with 6 NDC codes, marketed under brand names including Sinus Pressure and Pain PE Maximum Strength, Sinus Congestion and Pain Daytime, SINUS PAIN AND CONGESTION DAYTIME. Available dosage forms: tablet, tablet, film coated, tablet, coated.
Drug Details
- Generic Name
- Acetaminophen and Phenylephrine HCl
- Brand Names
- Sinus Pressure and Pain PE Maximum Strength, Sinus Congestion and Pain Daytime, SINUS PAIN AND CONGESTION DAYTIME, Sinus and Headache, Sinus Headache PEMaximum Strength Non-Drowsy Maximum Strength Non-Drowsy, Sinus Congestion and Pain Relief Non-Drowsy, Daytime
- Application Number
- M012
- Sponsor
- Rite Aid Corporation
- NDC Codes
- 6
- Dosage Forms
- TABLET, TABLET, FILM COATED, 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: minor aches and pains nasal congestion headache sinus congestion and pressure promotes sinus drainage 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: 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 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 heart disease thyroid disease diabetes liver disease high blood pressure 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.