Drugplain

Nighttime Cold and Flu Max Softgels 325 mg/1

Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl · CAPSULE, LIQUID FILLED · Topco Associates, LLC

No Recall HistoryCurrently in Shortage
Plain English

Nighttime Cold And Flu Max Softgels is an over-the-counter medication that combines acetaminophen (a pain reliever and fever reducer), dextromethorphan (a cough suppressant), doxylamine (a sleep aid), and phenylephrine (a decongestant) to relieve multiple cold and flu symptoms including aches, fever, cough, and nasal congestion while helping you sleep. This combination product is taken by mouth and is designed for nighttime use when you need symptom relief and rest.

Key Facts

Brand Name
Nighttime Cold and Flu Max Softgels
Generic Name
Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
NDC Code (Product)
76162-913
Manufacturer
Topco Associates, LLC
Strength
325 mg/1
Dosage Form
CAPSULE, LIQUID FILLED
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
09/25/2024

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves common cold/flu symptoms: • cough due to minor throat & bronchial irritation • sore throat • headache• minor aches & pains• fever• runny nose & sneezing

Dosage & Administration

Directions • take only as directed • do not exceed 8 softgels per 24 hrs • adults & children 12 yrs & over 2 Softgels with water every 6 hrs • children 4 to under 12 yrs ask a doctor • children under 4 yrs do not use

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 8 Softgels in 24 hrs, which is the maximum daily amount for this product • with other drugs containing acetaminophen • 3 or more alcoholic drinks daily 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.

Frequently Asked Questions

What is Nighttime Cold and Flu Max Softgels used for?

Nighttime Cold And Flu Max Softgels is an over-the-counter medication that combines acetaminophen (a pain reliever and fever reducer), dextromethorphan (a cough suppressant), doxylamine (a sleep aid), and phenylephrine (a decongestant) to relieve multiple cold and flu symptoms including aches, fever, cough, and nasal congestion while helping you sleep. This combination product is taken by mouth and is designed for nighttime use when you need symptom relief and rest.

Is Nighttime Cold and Flu Max Softgels a controlled substance?

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

What is the generic name for Nighttime Cold and Flu Max Softgels?

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

What is the NDC code for Nighttime Cold and Flu Max Softgels 325 mg/1?

The NDC (National Drug Code) for Nighttime Cold and Flu Max Softgels 325 mg/1 is 76162-913, listed by Topco Associates, LLC.