Drugplain

Robitussin Medi-Soothers 5 mg/1

dextromethorphan hydrobromide, menthol · LOZENGE · Haleon US Holdings LLC

No Recall History
Plain English

Robitussin Medi-Soothers is a prescription lozenge containing dextromethorphan hydrobromide, menthol at 5 mg/1, taken oral. Manufactured by Haleon US Holdings LLC.

Key Facts

Brand Name
Robitussin Medi-Soothers
Generic Name
dextromethorphan hydrobromide, menthol
NDC Code (Product)
0031-9306
Manufacturer
Haleon US Holdings LLC
Strength
5 mg/1
Dosage Form
LOZENGE
Route
ORAL
Marketing Status
HUMAN OTC DRUG
Application #
M012
Drug Class
Sigma-1 Agonist [EPC]; Sigma-1 Receptor Agonists [MoA]
Marketing Start
06/01/2023

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 indication1 reports
product use in unapproved indication1 reports
therapeutic product effect incomplete1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold occasional minor irritation, pain, sore mouth, and sore throat

Dosage & Administration

Directions adults and children 12 years of age and older: take 2 lozenges (one immediately after the other) every 4 hours as needed. Allow each lozenge to dissolve slowly in the mouth. do not take more than 12 lozenges in any 24-hour period, or as directed by a doctor children under 12 years of age: do not use

Warnings

Warnings Sore throat warning if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly Do Not Use if you are now taking 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. Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus) Stop use and ask a doctor or dentist if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. sore mouth symptoms do not improve in 7 days irritation, pain, or redness persists or worsens If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is Robitussin Medi-Soothers used for?

Robitussin Medi-Soothers contains dextromethorphan hydrobromide, menthol. It is a lozenge taken oral. Consult your doctor for specific uses.

Is Robitussin Medi-Soothers a controlled substance?

Robitussin Medi-Soothers is not classified as a controlled substance by the DEA.

What is the generic name for Robitussin Medi-Soothers?

The generic name for Robitussin Medi-Soothers is dextromethorphan hydrobromide, menthol. There are no other listed brand versions of dextromethorphan hydrobromide, menthol.

What is the NDC code for Robitussin Medi-Soothers 5 mg/1?

The NDC (National Drug Code) for Robitussin Medi-Soothers 5 mg/1 is 0031-9306, listed by Haleon US Holdings LLC.

Product NDC

0031-9306

Package NDC

0031-9306-01

Other Robitussin Medi-Soothers Dosages

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)