Tussin DMMax
- Manufacturer
- RELIABLE 1 LABORATORIES LLC
- Effective date
- 2026-01-02
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- monthly-update
- Hydrated at
- 2026-06-03 17:52:26
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients (in each 20 mL)
Dextromethorphan HBr 20mg
Guaifenesin 400 mg
OTC - PURPOSE SECTION
Purpose
Cough Suppressant
Expectorant
INDICATIONS & USAGE SECTION
Uses
- temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
WARNINGS SECTION
Warnings
Do not use if you are now taking a 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.
OTC - ASK DOCTOR SECTION
Ask a doctor before us if you have
- cough that occurs with too much phlegm (mucus)
- cough that lasts 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 than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
When using this prodcut, do not use more than directed.
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 take more than 6 doses in any 24-hour period
- measure only with dosing cup provided
- do not use dosing cup with other products
- mL = mililiters
- adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours
- children under 12 years of age: do not use
INACTIVE INGREDIENT SECTION
Inactive ingredients
Artificial and natural flavor, citric acid, FD&C Blue #1, FD&C Red #40, hydroxyethylcellulose, L-menthol, methylparaben, propylen glycol, propylparaben, purified water, sodium citrate, sucralose, and sucrose.
OTC - QUESTIONS SECTION
Questions or comments?
Call 1-516-341-0666 8:30 am - 4:30 pm EST Mon-Fri
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1020138 | dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution | PSN | 4 |
| 1020138 | dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution | SCD | 4 |
| 1020138 | dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution | SY | 4 |
| 1020138 | dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral Solution | SY | 4 |
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 |
|---|---|---|---|
| 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69618-072-58 | 2026-01-09 | C162847 | 48780-1 | 2cef2736-ad1a-d83d-e063-dadaa90ab31f | c4bb2e12-e0f6-4cbf-ad24-cfad9326f7fa |
| 69618-072-58 | 2026-01-09 | C162847 | 48780-1 | 2cef2736-ad1a-d83d-e063-dadaa90ab31f | Reliable Tussin DMMax 072 |
| 69618-072-58 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-ad1a-d83d-e063-dadaa90ab31f | c4bb2e12-e0f6-4cbf-ad24-cfad9326f7fa |
| 69618-072-58 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-ad1a-d83d-e063-dadaa90ab31f | Reliable Tussin DMMax 072 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69618-072-58 | Tussin DMMax | 237 mL in 1 BOTTLE | LIQUID | 237 | 4 | |
| 69618-072-58 | Tussin DMMax | 1 in 1 CARTON | LIQUID | 1 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69618-072-58 | ML - Milliliter | 69618-072 | d0861b1b-d68a-4692-8b58-656623c98299 | 1 | 2023-01-09 |
Products#
Every source-derived product name is available through these pages.
- Tussin DMMax
- Dextromethorphan HBr, Guaifenesin
- ANHYDROUS CITRIC ACID
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- HYDROXYETHYL CELLULOSE, UNSPECIFIED
- MENTHOL
- METHYLPARABEN
- PROPYLENE GLYCOL
- PROPYLPARABEN
- WATER
- SODIUM CITRATE
- SUCRALOSE
- SUCROSE
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- GUAIFENESIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69618-072 | 69618-072-58 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| HYDROXYETHYL CELLULOSE, UNSPECIFIED | T4V6TWG28D | IACT |
| MENTHOL | L7T10EIP3A | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| SUCROSE | C151H8M554 | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| GUAIFENESIN | 495W7451VQ | ACTIB |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 1 | 2022-12-29 | full-release | 2026-05-31 23:52:45 |
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 |
|---|---|---|---|---|---|---|
| Tussin DMMax | DEXTROMETHORPHAN HBR, GUAIFENESIN | RELIABLE 1 LABORATORIES LLC | c4bb2e12-e0f6-4cbf-ad24-cfad9326f7fa | 2026-01-02 | Warnings | 69618-072-58 69618-072 69618007258 47fd1379-0cd5-9b54-e063-6394a90a3948 c4bb2e12-e0f6-4cbf-ad24-cfad9326f7fa |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
