Drugplain

Cold and Flu Nighttime 650 mg/30mL

Acetaminophen, Dextromethorphan HBr, Doxylamine succinate · SOLUTION · Lidl US LLC

1 Recall on RecordCurrently in Shortage
Plain English

Cold and Flu Nighttime is a solution containing acetaminophen, dextromethorphan hbr, doxylamine succinate at 650 mg/30mL, taken oral. Manufactured by Lidl US LLC.

Key Facts

Brand Name
Cold and Flu Nighttime
Generic Name
Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
NDC Code (Product)
71141-180
Manufacturer
Lidl US LLC
Strength
650 mg/30mL
Dosage Form
SOLUTION
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
07/07/2023

Recall History

1 Recall on Record
Class II08/29/2013

Procter & Gamble Co

Incorrect/ Undeclared Excipients: NyQuil Liquid Original bottles were inadvertently overwrapped with NyQuil Liquid Cherry information as a result the outer wrap does not correctly identify color additives, particularly FD&C Yellow No. 6 and FD&C Yellow 10.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

covid-19171 reports
disease recurrence134 reports
nasopharyngitis126 reports
fatigue103 reports
cough96 reports
nausea95 reports
dizziness81 reports
drug ineffective81 reports
diarrhoea79 reports
vomiting74 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses Uses temporarily relieves common cold and flu symptoms: minor aches and pains sinus congestion and pressure sore throat fever headache nasal congestion cough due to minor throat and bronchial irritation cough to help you sleep runny nose and sneezing reduces swelling of nasal passages promotes nasal and/or sinus drainage temporarily restores freer breathing through the nose

Dosage & Administration

Directions Directions do not take more than directed do not take more than 8 caplets in 24 hours adults and children 12 years and over: take 2 caplets with water every 4 hours children under 12 years: ask a doctor

Warnings

Warnings ​Warnings Liver warning Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: blisters rash skin reddening If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning 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 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 h

Frequently Asked Questions

What is Cold and Flu Nighttime used for?

Cold and Flu Nighttime contains Acetaminophen, Dextromethorphan HBr, Doxylamine succinate. It is a solution taken oral. Consult your doctor for specific uses.

Is Cold and Flu Nighttime a controlled substance?

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

What is the generic name for Cold and Flu Nighttime?

The generic name for Cold and Flu Nighttime is Acetaminophen, Dextromethorphan HBr, Doxylamine succinate. There are 11 other brand versions of Acetaminophen, Dextromethorphan HBr, Doxylamine succinate.

What is the NDC code for Cold and Flu Nighttime 650 mg/30mL?

The NDC (National Drug Code) for Cold and Flu Nighttime 650 mg/30mL is 71141-180, listed by Lidl US LLC.