Drugplain

Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime 650 mg/20mL

acetaminophen, diphenhydramine hcl · LIQUID · Haleon US Holdings LLC

No Recall HistoryCurrently in Shortage
Plain English

Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime is a liquid containing acetaminophen, diphenhydramine hcl at 650 mg/20mL, taken oral. Manufactured by Haleon US Holdings LLC.

Key Facts

Brand Name
Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime
Generic Name
acetaminophen, diphenhydramine hcl
NDC Code (Product)
0031-0101
Manufacturer
Haleon US Holdings LLC
Strength
650 mg/20mL
Dosage Form
LIQUID
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
02/15/2024

Recall History

No Recall History

Side Effects Reported to FDA

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

disorientation1 reports
drug toxicity1 reports
malaise1 reports
product commingling1 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 respiratory allergies: cough due to minor throat and bronchial irritation headache sore throat minor aches and pains runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily relieves your cough to help you rest temporarily reduces fever

Dosage & Administration

Directions do not take more than 6 doses in any 24-hour period do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage. measure only with dosing cup provided keep dosing cup with product mL = milliliter this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 20 mL every 4 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 6 doses 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 with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other drug containing diphenhydramine, even one used on skin Ask a doctor before use if you have liver disease trouble urinating due to an enlarged prostate gland glaucoma a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phle

Frequently Asked Questions

What is Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime used for?

Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime contains acetaminophen, diphenhydramine hcl. It is a liquid taken oral. Consult your doctor for specific uses.

Is Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime a controlled substance?

Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime is not classified as a controlled substance by the DEA.

What is the generic name for Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime?

The generic name for Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime is acetaminophen, diphenhydramine hcl. There are 12 other brand versions of acetaminophen, diphenhydramine hcl.

What is the NDC code for Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime 650 mg/20mL?

The NDC (National Drug Code) for Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime 650 mg/20mL is 0031-0101, listed by Haleon US Holdings LLC.