Chlorpheniramine maleate and Phenylephrine HCl

FDA Drug Profile — Sinus PE plus Allergy, Sinus and Allergy Relief PE

Drug Details

Generic Name
Chlorpheniramine maleate and Phenylephrine HCl
Brand Names
Sinus PE plus Allergy, Sinus and Allergy Relief PE
Application Number
M012
Sponsor
Walgreen Company
NDC Codes
2
Dosage Forms
TABLET
Routes
ORAL
Active Ingredients
CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE

Indications and Usage

Uses temporarily relieves these symptoms of hay fever or other upper respiratory allergies: headache nasal congestion runny nose and sneezing minor aches and pains sinus congestion and pressure temporarily relieves these additional symptoms of hay fever: itchy, watery eyes itching of the nose or throat helps clear nasal passages helps decongest sinus openings and passages

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 difficulty in urination due to enlargement of the prostate gland glaucoma high blood pressure a breathing problem such as emphysema or chronic bronchitis heart disease thyroid disease diabetes liver disease Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product do not exceed recommended dosage excitability may occur, especially in children alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery drowsiness may occur Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present 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.