Drugplain

Night Cold Flu Cough and Allergy 325 mg/1

acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride · CAPSULE, LIQUID FILLED · Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.

No Recall HistoryCurrently in Shortage
Plain English

Night Cold Flu Cough and Allergy is a capsule, liquid filled containing acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride at 325 mg/1, taken oral. Manufactured by Humanwell PuraCap Pharmaceutical (Wuhan), Ltd..

Key Facts

Brand Name
Night Cold Flu Cough and Allergy
Generic Name
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
NDC Code (Product)
53345-020
Manufacturer
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
Strength
325 mg/1
Dosage Form
CAPSULE, LIQUID FILLED
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
05/29/2013

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves these symptoms due to a cold or flu: minor aches and pains headache nasal and sinus congestion cough sore throat runny nose sneezing temporarily reduces fever

Dosage & Administration

Directions do not take more than the recommended dose adults and children 12 years of age and over: take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor. children under 12 years of age: do not use

Warnings

Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 10 softgels in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product 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 to sedate children. 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 in children under 12 years of age Ask a doctor before use if you have liver disease heart disease high blood

Frequently Asked Questions

What is Night Cold Flu Cough and Allergy used for?

Night Cold Flu Cough and Allergy contains acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride. It is a capsule, liquid filled taken oral. Consult your doctor for specific uses.

Is Night Cold Flu Cough and Allergy a controlled substance?

Night Cold Flu Cough and Allergy is not classified as a controlled substance by the DEA.

What is the generic name for Night Cold Flu Cough and Allergy?

The generic name for Night Cold Flu Cough and Allergy is acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride. There are 12 other brand versions of acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride.

What is the NDC code for Night Cold Flu Cough and Allergy 325 mg/1?

The NDC (National Drug Code) for Night Cold Flu Cough and Allergy 325 mg/1 is 53345-020, listed by Humanwell PuraCap Pharmaceutical (Wuhan), Ltd..