acetaminophen, dextromethorphan hbr, phenylephrine hcl solution

FDA Drug Profile — DayTime Relief, Cold and Flu, 24-7 Life by 7-Eleven, Daytime Cold and Flu Relief, 24-7 Life BY 7-Eleven

Drug Details

Generic Name
acetaminophen, dextromethorphan hbr, phenylephrine hcl solution
Brand Names
DayTime Relief, Cold and Flu, 24-7 Life by 7-Eleven, Daytime Cold and Flu Relief, 24-7 Life BY 7-Eleven
Application Number
M012
Sponsor
Lil' Drug Store Products, Inc.
NDC Codes
2
Dosage Forms
LIQUID, SOLUTION
Routes
ORAL
Active Ingredients
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE

Indications and Usage

Uses Uses temporarily relieves common cold and flu symptoms: sore throat nasal congestion minor aches and pains headache cough due to minor throat and bronchial irritation temporarily reduces fever

Warnings

Warnings Liver warning Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult takes more than 4,000 mg of acetaminophen in 24 hours child takes more than 5 doses in 24 hours taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks every day while using this product Allergy alert 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 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 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 Ask a doctor before use if the user has difficulty in urination due to enlargement of the prostate cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, or emphysema heart disease diabetes thyroid disease liver disease high blood pressure Ask a doctor or pharmacist before use Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin. When using this product When using this product do not exceed recommended dosage. Stop use and ask a doctor Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults) cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children 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.