Acetaminophen,Dextromethorphan,Doxylamine

FDA Drug Profile — NightTime Cold and Flu

Drug Details

Generic Name
Acetaminophen,Dextromethorphan,Doxylamine
Brand Names
NightTime Cold and Flu
Application Number
part341
Sponsor
Velocity Pharma
NDC Codes
1
Dosage Forms
CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE

Indications and Usage

Uses pain reliever, cough suppressant and Antihistamine

Warnings

Warnings Warnings Failure to follow these warnings could result in serious consequences. Liver Warning: This product contains acetaminophen . Severe liver damage may occur if you take more than 4 doses in 24 hours which is maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product do not use: with any other drug containing acetaminophen (prescription or not prescription). 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 Thyroid disease Diabetes High blood pressure Trouble urinating due to enlarged prostate gland ask your doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product, do not use more than directed. Stop use and ask a doctor if: Redness or swelling is present You get nervous, dizzy or sleepless Fever gets worse or lasts more than 3 days New symptoms occur Symptoms do not get better within 7 days or are accompanied by a fever