Nighttime Cold and Flu 325 mg/1

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

No Recall HistoryCurrently in Shortage

Plain English

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

Key Facts

Brand Name: Nighttime Cold and Flu
Generic Name: acetaminophen, dextromethorphan hydrobromide, doxylamine succinate
NDC Code (Product): 53345-026
Manufacturer: Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
Strength: 325 mg/1
Dosage Form: CAPSULE, LIQUID FILLED
Route: ORAL
Marketing Status
Application #: M012
Marketing Start: 08/11/2014

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves these common cold/flu symptoms minor aches and pains headache sore throat fever runny nose and sneezing cough due to minor throat and bronchial irritation

Dosage & Administration

Directions do not take more than directed (see Overdose warning) do not take more than 4 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. mL = milliliter keep dosing cup with product adults and children 12 years and over: 30 mL every 6 hours children under 12 years of age: do not use when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 4000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks everyday 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 is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use 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. with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist Ask a doctor before use if you have liver disease glaucoma cough that occur…

Frequently Asked Questions

What is Nighttime Cold and Flu used for?

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

Is Nighttime Cold and Flu a controlled substance?

Nighttime Cold and Flu is not classified as a controlled substance by the DEA.

What is the generic name for Nighttime Cold and Flu?

The generic name for Nighttime Cold and Flu is acetaminophen, dextromethorphan hydrobromide, doxylamine succinate. There are 12 other brand versions of acetaminophen, dextromethorphan hydrobromide, doxylamine succinate.

What is the NDC code for Nighttime Cold and Flu 325 mg/1?

The NDC (National Drug Code) for Nighttime Cold and Flu 325 mg/1 is 53345-026, listed by Humanwell PuraCap Pharmaceutical (Wuhan), Ltd..

Product NDC

53345-026

Package NDC

53345-026-01

Other Acetaminophen, Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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