Drugplain

Mucinex Nightshift Cold and Flu 650 mg/20mL

Acetaminophen, Dextromethorphan Hydrobromide, and Triprolidine Hydrochloride · SOLUTION · Reckitt Benckiser LLC

No Recall HistoryCurrently in Shortage
Plain English

Mucinex Nightshift Cold and Flu is an over-the-counter liquid medication that combines acetaminophen (a pain reliever and fever reducer), dextromethorphan (a cough suppressant), and triprolidine (an antihistamine) to help relieve cold and flu symptoms. This combination product is designed to provide symptom relief, particularly for nighttime use when the antihistamine may also help with sleep.

Key Facts

Brand Name
Mucinex Nightshift Cold and Flu
Generic Name
Acetaminophen, Dextromethorphan Hydrobromide, and Triprolidine Hydrochloride
NDC Code (Product)
63824-503
Manufacturer
Reckitt Benckiser LLC
Strength
650 mg/20mL
Dosage Form
SOLUTION
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
06/15/2019

Recall History

No Recall History

Side Effects Reported to FDA

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

drug effective for unapproved indication2 reports
headache2 reports
arthralgia1 reports
bronchitis1 reports
cellulitis1 reports
cough1 reports
covid-191 reports
dizziness1 reports
dysphagia1 reports
hyperhidrosis1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses MUCINEX FAST-MAX DM MAX helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep MUCINEX NIGHTSHIFT COLD & FLU temporarily relieves these common cold and flu symptoms: cough minor aches and pains sore throat headache runny nose sneezing itching of the nose or throat itchy, watery eyes due to hay fever temporarily reduces fever controls cough to help you get to sleep

Dosage & Administration

Directions MUCINEX FAST-MAX DM MAX do not take more than 6 doses in any 24-hour period measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours children under 12 years of age: do not use MUCINEX NIGHTSHIFT COLD & FLU 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 dosing cup with other products dose as follows or as directed by a doctor adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours children under 12 years of age: do not use

Warnings

Warnings Liver warning (Nightshift Cold & Flu only) This product contains acetaminophen. Severe liver damage may occur if you take: more than 4000 mg in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Allergy alert (Nightshift Cold & Flu only) 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 (Nightshift Cold & Flu only) 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. (Nightshift Cold & Flu only) 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 …

Frequently Asked Questions

What is Mucinex Nightshift Cold and Flu used for?

Mucinex Nightshift Cold and Flu is an over-the-counter liquid medication that combines acetaminophen (a pain reliever and fever reducer), dextromethorphan (a cough suppressant), and triprolidine (an antihistamine) to help relieve cold and flu symptoms. This combination product is designed to provide symptom relief, particularly for nighttime use when the antihistamine may also help with sleep.

Is Mucinex Nightshift Cold and Flu a controlled substance?

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

What is the generic name for Mucinex Nightshift Cold and Flu?

The generic name for Mucinex Nightshift Cold and Flu is Acetaminophen, Dextromethorphan Hydrobromide, and Triprolidine Hydrochloride. There are 5 other brand versions of Acetaminophen, Dextromethorphan Hydrobromide, and Triprolidine Hydrochloride.

What is the NDC code for Mucinex Nightshift Cold and Flu 650 mg/20mL?

The NDC (National Drug Code) for Mucinex Nightshift Cold and Flu 650 mg/20mL is 63824-503, listed by Reckitt Benckiser LLC.

Product NDC

63824-503

Package NDC

63824-503-66

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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)