Indications and uses
Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes coughs more productive.
Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes coughs more productive.
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 tablet every 12 hours. Do not exceed 4 tablets in 24 hours. children under 12 years of age: do not use
store between 20º to 25ºC (68º to 77ºF)
Guaifenesin 600 mg
Expectorant
Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes coughs more productive.
for children under 12 years of age.
cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious illness.
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
carbomer, colloidal silicon dioxide, FD&C blue #1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, talc
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Compare to the active ingredient Mucinex®*
Mucus Relief ER
Guaifenesin 600 mg
Expectorant
Extended-release tablets
*This product is not manufactured or distributed by Reckitt Benckiser LLC, distributor of Mucinex®.
TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
| Class | Version | Type | Effective |
|---|---|---|---|
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0904-6718-39 | Mucus Relief ER | 1 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 1 | 6 | |
| 0904-6718-39 | Mucus Relief ER | 100 in 1 CARTON | TABLET, EXTENDED RELEASE | 100 | 6 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-6718-39 | EA - Each | 0904-6718 | d92d08de-0344-44fe-b4c0-e7f1ab2254bd | 1 | 2019-02-13 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0904-6718 | 0904-6718-39 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GUAIFENESIN | 495W7451VQ | ACTIB |
| CARBOMER 934 | Z135WT9208 | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| POVIDONE | FZ989GH94E | IACT |
| TALC | 7SEV7J4R1U | IACT |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A207342-001 | GUAIFENESIN | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | ||
| A207342-002 | GUAIFENESIN | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 |
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 | A207342-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A207342-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A207342-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A207342-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A207342-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A207342-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207342-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207342-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207342-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207342-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207342-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207342-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207342-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207342-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207342-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207342-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207342-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207342-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207342-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207342-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207342-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207342-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A207342-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A207342-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207342-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207342-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207342-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207342-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207342-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207342-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A207342-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A207342-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207342-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207342-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A207342-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A207342-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A207342-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A207342-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A207342-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A207342-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-11 | 74a2ff9319b5… |
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 ER | GUAIFENESIN | Major Pharmaceuticals | e5a242bf-3008-4c92-a930-e76f733be5cf | 2025-03-07 | Warnings | 0904-6718-39 0904-6718 00904671839 ebcfe516-e74c-4f97-8ade-85cfbadf4f33 e5a242bf-3008-4c92-a930-e76f733be5cf |
Adverse event summaries are temporarily unavailable. Other product information remains available.