acetaminophen, dextromethorphan hydrobromide, guaifenesin, doxylamine succinate

FDA Drug Profile — Coricidin HBP Maximum Strength Cold and Flu Day and Night

Drug Details

Generic Name
acetaminophen, dextromethorphan hydrobromide, guaifenesin, doxylamine succinate
Brand Names
Coricidin HBP Maximum Strength Cold and Flu Day and Night
Application Number
M012
Sponsor
Bayer HealthCare LLC.
NDC Codes
1
Dosage Forms
KIT
Routes
ORAL
Active Ingredients
N/A

Indications and Usage

Uses • temporarily relieves: • nasal congestion • headache • cough • minor aches & pains • sinus congestion & pressure • runny nose and sneezing (NIGHT only) • temporarily promotes nasal and/or sinus drainage • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY only)

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: • more than 12 softgels in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using these products 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. Ask a doctor before use if you have • liver disease • heart disease • diabetes • high blood pressure • thyroid disease • trouble urinating due to an enlarged prostate gland • glaucoma (NIGHT only) • a breathing problem such as emphysema or chronic bronchitis (NIGHT only) • persistent or chronic cough such 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 (NIGHT only) When using these products • do not use more than directed • excitability may occur, especially in children (NIGHT only) • marked drowsiness may occur (NIGHT only) • alcohol, sedatives, and tranquilizers may increase drowsiness (NIGHT only) • avoid alcoholic drinks (NIGHT only) • be careful when driving a motor vehicle or operating machinery (NIGHT 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 • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • 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. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away.