Drugplain

Nighttime Cold and Flu 325 mg/1

Acetaminophen, Doxylamine Succinate, Dextromethorphan HBr · CAPSULE, LIQUID FILLED · Health Pharma USA LLC

No Recall HistoryCurrently in Shortage
Plain English

Nighttime Cold and Flu is an over-the-counter medicine in capsule form that contains acetaminophen to reduce fever and pain, doxylamine succinate to help you sleep, and dextromethorphan to suppress cough. It is taken by mouth to relieve multiple cold and flu symptoms at nighttime.

Key Facts

Brand Name
Nighttime Cold and Flu
Generic Name
Acetaminophen, Doxylamine Succinate, Dextromethorphan HBr
NDC Code (Product)
71679-102
Manufacturer
Health Pharma USA LLC
Strength
325 mg/1
Dosage Form
CAPSULE, LIQUID FILLED
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
12/20/2024

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 is an over-the-counter medicine in capsule form that contains acetaminophen to reduce fever and pain, doxylamine succinate to help you sleep, and dextromethorphan to suppress cough. It is taken by mouth to relieve multiple cold and flu symptoms at nighttime.

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, Doxylamine Succinate, Dextromethorphan HBr. There are 4 other brand versions of Acetaminophen, Doxylamine Succinate, Dextromethorphan HBr.

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 71679-102, listed by Health Pharma USA LLC.

Product NDC

71679-102

Package NDC

71679-102-00

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

Data from openFDA · Public domain (CC0 1.0)