Curewell Tussin DM
- Manufacturer
- RMT HEALTH LLC
- Effective date
- 2026-05-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- daily-update
- Hydrated at
- 2026-06-03 18:04:11
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients (per 10ml = 2 teaspoonfuls)
Dextromethorphan HBr 20 mg
Guaifenesin, USP 200mg
OTC - PURPOSE SECTION
Purposes
Cough Suppressant
Expectoran
INDICATIONS & USAGE SECTION
Uses
• temporarily relieves cough due to minor throat and bronchial secretions to make coughs more productive
WARNINGS SECTION
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.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have • cough that occurs with too much phlegm (mucus) • cough that last or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema.
OTC - STOP USE SECTION
Stop use and ask a doctor if • cough lasts more that 7 days, comes back or is accompanied by fever, rash, or, persistent headache. These could be signs of a serious condition.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding,ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away
DOSAGE & ADMINISTRATION SECTION
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 |
OTHER SAFETY INFORMATION
Other information
• each 10 ml contains: sodium 20 mg
• TAMPER EVIDENT: Do not use if foil seal over bottle opening is torn, broken or missing. •store at room temperature between
15ºC-30ºC (59ºF-68ºF) •protect from freezing •protect from light
INACTIVE INGREDIENT SECTION
Inactive ingredients: artificial and natural cherry flavor, citric acid, FD&C red #40, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose
OTC - QUESTIONS SECTION
Questions or comments? 1-845-367-0500 or info@mycurewell.com
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 996520 | dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral Solution | PSN | 2 |
| 996520 | dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution | SCD | 2 |
| 996520 | dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution | SY | 2 |
| 996520 | dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution | SY | 2 |
| 996520 | dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution | SY | 2 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
Products#
Every source-derived product name is available through these pages.
- Curewell Tussin DM
- Dextromethorphan, Guaifenesin
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- ANHYDROUS CITRIC ACID
- MENTHOL
- METHYLPARABEN
- PROPYLENE GLYCOL
- PROPYLPARABEN
- WATER
- SODIUM CITRATE
- SUCRALOSE
- GUAIFENESIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 85111-802 | 85111-802-16 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| MENTHOL | L7T10EIP3A | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| GUAIFENESIN | 495W7451VQ | ACTIB |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 1 | 2026-04-20 | full-release | 2026-06-01 01:54:24 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Curewell Tussin DM | DEXTROMETHORPHAN, GUAIFENESIN | RMT HEALTH LLC | 4fe9ad93-cdc4-b4df-e063-6294a90a90ae | 2026-05-15 | Warnings | 85111-802-16 85111-802 85111080216 51dbb3fc-e87e-7807-e063-6394a90af808 4fe9ad93-cdc4-b4df-e063-6294a90a90ae |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
