Drugplain

Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime 325 mg/1

acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate · CAPSULE, LIQUID FILLED · Haleon US Holdings LLC

No Recall HistoryCurrently in Shortage
Plain English

This over-the-counter nighttime cold and flu medicine combines acetaminophen (a pain reliever and fever reducer), dextromethorphan (a cough suppressant), and doxylamine (a sleep aid) to relieve multiple symptoms including cough, congestion, aches, fever, and sleeplessness. It comes as a liquid-filled capsule taken by mouth.

Key Facts

Brand Name
Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime
Generic Name
acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate
NDC Code (Product)
0031-8744
Manufacturer
Haleon US Holdings LLC
Strength
325 mg/1
Dosage Form
CAPSULE, LIQUID FILLED
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
07/01/2015

Recall History

No Recall History

Side Effects Reported to FDA

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

adverse drug reaction2 reports
dizziness2 reports
abdominal pain upper1 reports
adverse event1 reports
cold sweat1 reports
death1 reports
decreased appetite1 reports
drug screen positive1 reports
dyspnoea1 reports
expired product administered1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves these symptoms occurring with a cold or flu, hay fever, or other upper respiratory allergies: headache sore throat cough minor aches and pains runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily reduces fever

Dosage & Administration

Directions do not take more than 8 capsules in any 24-hour period do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage. this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 2 capsules every 6 hours children under 12 years do not use

Warnings

Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 8 capsules in any 24-hour period, which is the maximum daily amount 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 to sedate a child or to make a child sleepy 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. with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask …

Frequently Asked Questions

What is Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime used for?

This over-the-counter nighttime cold and flu medicine combines acetaminophen (a pain reliever and fever reducer), dextromethorphan (a cough suppressant), and doxylamine (a sleep aid) to relieve multiple symptoms including cough, congestion, aches, fever, and sleeplessness. It comes as a liquid-filled capsule taken by mouth.

Is Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime a controlled substance?

Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime is not classified as a controlled substance by the DEA.

What is the generic name for Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime?

The generic name for Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime is acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate. There are 11 other brand versions of acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate.

What is the NDC code for Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime 325 mg/1?

The NDC (National Drug Code) for Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime 325 mg/1 is 0031-8744, listed by Haleon US Holdings LLC.

Product NDC

0031-8744

Package NDC

0031-8744-10

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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)