Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime 650 mg/20mL

acetaminophen and diphenhydramine hydrochloride · SOLUTION · Haleon US Holdings LLC

No Recall HistoryCurrently in Shortage

Plain English

Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime is a solution containing acetaminophen and diphenhydramine hydrochloride at 650 mg/20mL, taken oral. Manufactured by Haleon US Holdings LLC.

Key Facts

Brand Name: Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime
Generic Name: acetaminophen and diphenhydramine hydrochloride
NDC Code (Product): 0031-8770
Manufacturer: Haleon US Holdings LLC
Strength: 650 mg/20mL
Dosage Form: SOLUTION
Route: ORAL
Marketing Status
Application #: M012
Marketing Start: 06/15/2020

Recall History

No Recall History

Side Effects Reported to FDA

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

completed suicide158 reports

toxicity to various agents127 reports

death34 reports

cardio-respiratory arrest28 reports

intentional product misuse25 reports

pain25 reports

drug ineffective24 reports

fatigue24 reports

joint swelling20 reports

somnolence20 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: • cough due to minor throat and bronchial irritation • minor aches and pains • sore throat pain • headache • runny nose, sneezing, itchy watery eyes • itching of the nose and throat • temporarily relieves your cough to help you sleep • 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 product containing diphenhydramine, even one used on skin Ask a doctor before use if you have • liver disease • cough that occurs with too much phlegm (mucus) • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, emphysema or chronic bronchitis • if you have glaucoma or …

Frequently Asked Questions

What is Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime used for?

Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime contains acetaminophen and diphenhydramine hydrochloride. It is a solution taken oral. Consult your doctor for specific uses.

Is Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime a controlled substance?

Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime is not classified as a controlled substance by the DEA.

What is the generic name for Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime?

The generic name for Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime is acetaminophen and diphenhydramine hydrochloride. There are 11 other brand versions of acetaminophen and diphenhydramine hydrochloride.

What is the NDC code for Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime 650 mg/20mL?

The NDC (National Drug Code) for Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime 650 mg/20mL is 0031-8770, listed by Haleon US Holdings LLC.

Product NDC

0031-8770

Package NDC

0031-8770-12

Other Acetaminophen Brands

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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)