Curewell Tussin DM

DEXTROMETHORPHAN, GUAIFENESIN ORAL HUMAN OTC DRUG

Curewell Tussin DM is an FDA drug label for the active ingredient DEXTROMETHORPHAN, GUAIFENESIN manufactured by RMT HEALTH LLC administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260515.

Generic name
DEXTROMETHORPHAN, GUAIFENESIN
Manufacturer
RMT HEALTH LLC
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
85111-802
Application
M012
Label effective
20260515

About this product

Curewell Tussin DM is an FDA-registered drug product whose active ingredient is DEXTROMETHORPHAN, GUAIFENESIN. It is labelled by RMT HEALTH LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 85111-802, application M012, label effective 20260515. It is one of 3 FDA drug label records sharing the active ingredient DEXTROMETHORPHAN, GUAIFENESIN. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

What it is used for

Across FDA labelling, products containing DEXTROMETHORPHAN, GUAIFENESIN are most often described in connection with: temporarily relieves, cough due, minor throat, bronchial secretions, make coughs. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active Ingredients (per 10ml = 2 teaspoonfuls) Dextromethorphan HBr 20 mg Guaifenesin, USP 200mg

Indications & Usage

Uses • temporarily relieves cough due to minor throat and bronchial secretions to make coughs more productive

Dosage & Administration

Directions do not exceed recommended dose take every 4 hours as needed, or as directed by a doctor do not take more than 6 doses in 24 hours adults and children 12 years and over 10mL (2 teaspoonfuls) children under 12 years Do not use

Warnings

Warnings Do not use if you are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs fir depression, psychiatric or emotional conditions, or Parkinson's disease, or for 2 weeks after stopping drug contains an MAOI, as a doctor or pharmacist before taking this product.

More products with the same ingredient

DEXTROMETHORPHAN, GUAIFENESIN

Akin Cough Formula DM

Southern Sales & Service, Inc. View label

Guaifed DM

Aldama Pharmaceuticals, Inc View label

How products containing DEXTROMETHORPHAN, GUAIFENESIN compare

FDA lists 3 drug label records with DEXTROMETHORPHAN, GUAIFENESIN as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

Dosage formProductsManufacturerProducts
— — Aldama Pharmaceuticals, Inc 1
— — RMT HEALTH LLC 1
— — Southern Sales & Service, Inc. 1
— — — —
— — — —

Frequently asked questions

What is Curewell Tussin DM used for?
Uses • temporarily relieves cough due to minor throat and bronchial secretions to make coughs more productive

Who makes Curewell Tussin DM?
RMT HEALTH LLC is the labeler of record for Curewell Tussin DM. 3 FDA label records share the active ingredient DEXTROMETHORPHAN, GUAIFENESIN, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Curewell Tussin DM come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Curewell Tussin DM prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing DEXTROMETHORPHAN, GUAIFENESIN?
Yes. 3 FDA drug label records list DEXTROMETHORPHAN, GUAIFENESIN as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Curewell Tussin DM been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.