Drugplain

Severe Cold and Flu Relief Daytime/Nighttime

Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Guaifenesin, Phenylephrine HCl · KIT · ARMY AND AIR FORCE EXCHANGE SERVICE

No Recall HistoryCurrently in Shortage
Plain English

This over-the-counter cold and flu relief kit contains multiple active ingredients that work together to reduce fever and pain, suppress coughs, loosen mucus, relieve nasal congestion, and help you sleep during nighttime use. The daytime and nighttime formulations are designed to provide symptom relief throughout the day and night during cold and flu illness.

Key Facts

Brand Name
Severe Cold and Flu Relief Daytime/Nighttime
Generic Name
Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Guaifenesin, Phenylephrine HCl
NDC Code (Product)
55301-620
Manufacturer
ARMY AND AIR FORCE EXCHANGE SERVICE
Dosage Form
KIT
Marketing Status
Application #
M012
Marketing Start
08/31/2018

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves common cold and flu symptoms: minor aches and pains nasal congestion headache fever sore throat sinus congestion and pressure cough due to minor throat and bronchial irritation cough to help you sleep (Nighttime only) runny nose and sneezing (Nighttime only) reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (Daytime only)

Dosage & Administration

Directions do not take more than directed do not take more than 8 caplets of Daytime and Nighttime products in any 24-hour period adults and children 12 years and over: take 2 caplets with water every 4 hours children under 12 years: ask a doctor

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take with other drugs containing acetaminophen more than 4,000 mg of acetaminophen in 24 hours 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 if you have ever had an allergic reaction to this product or any of its ingredients 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 pr…

Frequently Asked Questions

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

This over-the-counter cold and flu relief kit contains multiple active ingredients that work together to reduce fever and pain, suppress coughs, loosen mucus, relieve nasal congestion, and help you sleep during nighttime use. The daytime and nighttime formulations are designed to provide symptom relief throughout the day and night during cold and flu illness.

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

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

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

The generic name for Severe Cold and Flu Relief Daytime/Nighttime is Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Guaifenesin, Phenylephrine HCl. There are 7 other brand versions of Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Guaifenesin, Phenylephrine HCl.

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

The NDC (National Drug Code) for Severe Cold and Flu Relief Daytime/Nighttime is 55301-620, listed by ARMY AND AIR FORCE EXCHANGE SERVICE.

Product NDC

55301-620

Package NDC

55301-620-08

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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)