Acetaminophen Diphenhydramine HCI phenylephrine HCI

FDA Drug Profile — Cough and Cold Nighttime

Drug Details

Generic Name
Acetaminophen Diphenhydramine HCI phenylephrine HCI
Brand Names
Cough and Cold Nighttime
Application Number
M012
Sponsor
Walgreens
NDC Codes
1
Dosage Forms
LIQUID
Routes
ORAL
Active Ingredients
ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE

Indications and Usage

Uses temporarily relieves these common cold and flu symptoms cough nasal congestion minor aches and pains sore throat headache runny nose sneezing temporarily reduces fever controls cough to help you get to sleep

Warnings

Warnings Liver warning: this product contains acetaminophen. Severe liver damage may occur if you take: more than 4,000 my 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. with any other drug containing diphenhydramine even one used on the skin 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. Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis 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 taking sedatives or tranquilizers When using this product, do not use more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks alcoholic, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating a machinery 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 new symptoms occur fever gets worse, or lasts more than 3 days redness or swelling is present cough comes back or occurs with rash or headache that lasts. These could be sign of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.