Indications and uses
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
MUCUS RELIEF GUAIFENESIN EXTENDED-RELEASE 600 mg - TWIN MED LLC
- Manufacturer
- TWIN MED LLC
- Effective date
- 2026-03-26
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 01:51:46
Label at a glance#
ProductMUCUS RELIEF GUAIFENESIN EXTENDED-RELEASE 600 mg
Active ingredientGUAIFENESIN
Label structure11 sections
Dosage and administration
do not crush, chew, or break tablet take with a full glass of water this product can be administered without regard for the timing of meals adults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours. children under 12 years of age: do not use
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each extended-release tablet)
Guaifenesin 600 mg
Purpose
Expectorant
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Warnings
Do not use
- for children under 12 years of age
Ask a doctor before use if you have
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough accompanied by too much phlegm (mucus)
Stop use and ask a doctor if
- cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.
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 (1-800-222-1222) right away.
Directions
- do not crush, chew, or break tablet
- take with a full glass of water
- this product can be administered without regard for the timing of meals
- adults and children 12 years of age and over:1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours.
- children under 12 years of age:do not use
Other information
- store between 20° to 25°C (68° to 77°F)
Inactive ingredients
Carbomer Homopolymer Type B, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate.
Questions?
call toll-free 1-844-912-4012
SPL UNCLASSIFIED SECTION
Manufactured for:
Twin Med LLC
11333 Greenstone Ave
Santa Fe Springs, CA 90670
ProCureProducts.com
PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55681-301-01 | MUCUS RELIEFGUAIFENESIN EXTENDED-RELEASE 600 mg | 100 in 1 BOTTLE | TABLET | 100 | 3 |
Products#
Every source-derived product name is available through these pages.
- MUCUS RELIEF GUAIFENESIN EXTENDED-RELEASE 600 mg
- GUAIFENESIN
- CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
- HYPROMELLOSE, UNSPECIFIED
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- SODIUM STARCH GLYCOLATE TYPE A
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55681-301 | 55681-301-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) | 809Y72KV36 | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| SODIUM STARCH GLYCOLATE TYPE A | H8AV0SQX4D | IACT |
| GUAIFENESIN | 495W7451VQ | ACTIB |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A213420-001 | GUAIFENESIN | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | ||
| A213420-002 | GUAIFENESIN | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 4b0b4de00fa7… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | bb7c543d1eb4… |
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 |
|---|---|---|---|---|---|---|
| MUCUS RELIEF GUAIFENESIN EXTENDED-RELEASE 600 mg | GUAIFENESIN | TWIN MED LLC | d9d13c67-51a1-aa79-e053-2995a90abdbb | 2026-03-26 | Warnings | 55681-301-01 55681-301 55681030101 4deb799b-66b2-ddb4-e063-6394a90acf05 d9d13c67-51a1-aa79-e053-2995a90abdbb |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.