Drugplain

Cold and Flu Severe Daytime/Nighttime

Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride, Doxylamine succinate · KIT · Topco Associates LLC

No Recall HistoryCurrently in Shortage
Plain English

This over-the-counter medication kit is used to relieve multiple cold and flu symptoms including fever, cough, congestion, and body aches during the day and night. The daytime and nighttime formulas contain different combinations of pain reliever, cough suppressant, expectorant, decongestant, and sleep aid ingredients to address symptoms at different times of day.

Key Facts

Brand Name
Cold and Flu Severe Daytime/Nighttime
Generic Name
Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride, Doxylamine succinate
NDC Code (Product)
76162-823
Manufacturer
Topco Associates LLC
Dosage Form
KIT
Marketing Status
Application #
M012
Marketing Start
11/03/2023

Recall History

No Recall History

Side Effects Reported to FDA

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

device difficult to use1 reports
disease progression1 reports
drug ineffective1 reports
eye pain1 reports
nasopharyngitis1 reports
neutropenia1 reports
ocular discomfort1 reports
platelet count decreased1 reports
product dose omission issue1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves these common cold and flu symptoms: cough sore throat headache nasal congestion minor aches and pains sinus congestion and pressure sneezing and runny nose (Nighttime only) helps clear nasal passages relieves cough to help you sleep helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive (Daytime only) temporarily reduces fever

Dosage & Administration

Directions do not take more than directed adults and children 12 years and over take 2 caplets every 4 hours swallow whole – do not crush, chew, or dissolve do not take more than 10 caplets in 24 hours children under 12 years: ask a doctor

Warnings

Warnings 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: 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 followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. 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 ingre…

Frequently Asked Questions

What is Cold and Flu Severe Daytime/Nighttime used for?

This over-the-counter medication kit is used to relieve multiple cold and flu symptoms including fever, cough, congestion, and body aches during the day and night. The daytime and nighttime formulas contain different combinations of pain reliever, cough suppressant, expectorant, decongestant, and sleep aid ingredients to address symptoms at different times of day.

Is Cold and Flu Severe Daytime/Nighttime a controlled substance?

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

What is the generic name for Cold and Flu Severe Daytime/Nighttime?

The generic name for Cold and Flu Severe Daytime/Nighttime is Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride, Doxylamine succinate. There are 6 other brand versions of Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride, Doxylamine succinate.

What is the NDC code for Cold and Flu Severe Daytime/Nighttime ?

The NDC (National Drug Code) for Cold and Flu Severe Daytime/Nighttime is 76162-823, listed by Topco Associates LLC.

Product NDC

76162-823

Package NDC

76162-823-12

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

Data from openFDA · Public domain (CC0 1.0)