Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl

FDA Drug Profile — Cold and Flu Severe Day Time / Night Time, Severe Cold and Flu Relief Daytime/Nighttime, Cold and Flu Severe, Daytime, Nighttime

Drug Details

Generic Name
Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Brand Names
Cold and Flu Severe Day Time / Night Time, Severe Cold and Flu Relief Daytime/Nighttime, Cold and Flu Severe, Daytime, Nighttime
Application Number
M012
Sponsor
DOLGENCORP, LLC
NDC Codes
3
Dosage Forms
KIT
Routes
N/A
Active Ingredients
N/A

Indications and Usage

Uses temporarily relieves these common cold and flu symptoms: cough headache sore throat minor aches and pains nasal congestion sinus congestion and pressure sneezing and runny nose (Nighttime only) helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive (Daytime only) helps clear nasal passages relieves cough to help you sleep 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. 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. 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 liver disease diabetes thyroid disease heart disease glaucoma (Nighttime only) cough that occurs with too much phlegm (mucus) difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema a breathing problem such as emphysema or chronic bronchitis (Nighttime only) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers (Nighttime only) When using this product do not exceed recommended dosage excitability may occur, especially in children (Nighttime only) marked drowsiness may occur (Nighttime only) avoid alcoholic beverages (Nighttime only) use caution when driving a motor vehicle or operating machinery (Nighttime only) alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only) 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 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 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. Do not take DAYTIME and NIGHTTIME products at the same time.