OTC - ACTIVE INGREDIENT SECTION
Each immediate release tablet contains: Guaifenesin 400 mg
Each immediate release tablet contains: Guaifenesin 400 mg
PURPOSE: EXPECTORANT
Keep Out of Reach of Children: In case of overdose, get medical help or contact a Poison Control Center
Silicon Dioxide, Magnesium Stearate, Maltodextrin, Cellulose, Microcrystalline, Povidone, Sodium Starch Glycolate, Stearic Acid
Adults and children 12 years of age and older, take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours. Children under 12 years of age do not use
Helps loosen phlegm (mucus) and thin
bronchial secretions to make coughts more productive to rid the bronchial passageway of bothersome mucus.
Ask a doctor berfoe use if you have: Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema; Cough accompanied by excessive phlegm (mucus)
Product: 50436-6232
NDC: 50436-6232-2 60 TABLET in a BOTTLE
| Class | Version | Type | Effective |
|---|---|---|---|
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Data code | Data Matrix | 50436623202\XXXXXX\XXXXXX | lbl504366232.jpg |
| 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 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50436-6232-2 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1859-a910-e053-dadaa90a0b85 | 33f9c655-87f5-4cbb-889f-fbb3f376b09d |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50436-6232-2 | MUCOSA | 60 in 1 BOTTLE | TABLET | 60 | 4 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50436-6232 | MUCOSA (GUAIFENESIN) TABLET [UNIT DOSE SERVICES] | 4 | Legacy NDC, 1 package rows | 20170719_33f9c655-87f5-4cbb-889f-fbb3f376b09d.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49483-272-06 | EA - Each | 49483-272 | 58558786-c85e-40fc-96a2-3b3579028fcd | 1 | 2012-07-24 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 50436-6232 | 50436-6232-2 |
| 49483-272 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GUAIFENESIN | 495W7451VQ | ACTIB |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POVIDONE, UNSPECIFIED | FZ989GH94E | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
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 |
|---|---|---|---|---|---|---|
| MUCOSA | GUAIFENESIN | TIME CAP LABORATORIES,INC | d34ef2e8-adc2-48e5-a572-e354937daec6 | 2023-11-02 | Warnings | 49483-272 |
| 59ee6d3e-bacf-4888-adba-6f421d9e2603 | 33f9c655-87f5-4cbb-889f-fbb3f376b09d | 2017-07-19 | Warnings | 59ee6d3e-bacf-4888-adba-6f421d9e2603 33f9c655-87f5-4cbb-889f-fbb3f376b09d |
Adverse event summaries are temporarily unavailable. Other product information remains available.