Indications and uses
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make 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 tablet every 12 hours. Do not exceed 2 tablets in 24 hours. children under 12 years of age: do not use
Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing. store between 20-25°C (68-77°F)
Drug Facts
Guaifenesin 1200 mg
Expectorant
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
carbomer homopolymer type B; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF
(1-800-406-7984)
You may also report side effects to this phone number.
DISTRIBUTED BY:
SAM'S WEST, INC.
BENTONVILLE, AR 72716
Compare to Maximum Strength
Mucinex® active ingredient*
NDC 68196-072-56
Member's Mark™
12
HOUR
Maximum Strength
Mucus Relief
Guaifenesin 1200 mg
Extended-Release Tablets,
Expectorant
actual size
56
Extended-
Release
Tablets

| Class | Version | Type | Effective |
|---|---|---|---|
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68196-072-56 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-5692-a910-e053-dadaa90a0b85 | GUAIFENESIN EXTENDED-RELEASE TABLETS, 1200 mg |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68196-072-56 | Guaifenesin Extended Release | 4 in 1 CARTON | TABLET, EXTENDED RELEASE | 4 | 5 | |
| 68196-072-56 | Guaifenesin Extended Release | 14 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 14 | 5 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68196-072 | 68196-072-56 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|---|
| N021282-001 | MUCINEX | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2002-07-12 | |
| N021282-002 | MUCINEX | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2002-12-18 |
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 | N021282-001 | MUCINEX | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2002-07-12 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021282-002 | MUCINEX | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2002-12-18 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021282-001 | MUCINEX | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2002-07-12 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021282-002 | MUCINEX | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2002-12-18 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021282-001 | MUCINEX | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2002-07-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021282-002 | MUCINEX | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2002-12-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021282-001 | MUCINEX | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2002-07-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021282-002 | MUCINEX | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2002-12-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021282-001 | MUCINEX | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2002-07-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021282-002 | MUCINEX | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2002-12-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021282-001 | MUCINEX | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2002-07-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021282-002 | MUCINEX | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2002-12-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021282-001 | MUCINEX | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2002-07-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021282-002 | MUCINEX | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2002-12-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021282-001 | MUCINEX | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2002-07-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021282-002 | MUCINEX | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2002-12-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021282-001 | MUCINEX | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2002-07-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021282-002 | MUCINEX | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2002-12-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021282-001 | MUCINEX | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2002-07-12 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021282-002 | MUCINEX | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2002-12-18 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021282-001 | MUCINEX | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2002-07-12 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021282-002 | MUCINEX | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2002-12-18 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021282-001 | MUCINEX | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2002-07-12 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021282-002 | MUCINEX | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2002-12-18 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021282-001 | MUCINEX | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2002-07-12 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021282-002 | MUCINEX | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2002-12-18 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021282-001 | MUCINEX | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2002-07-12 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021282-002 | MUCINEX | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2002-12-18 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021282-001 | MUCINEX | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2002-07-12 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021282-002 | MUCINEX | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2002-12-18 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021282-001 | MUCINEX | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2002-07-12 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021282-002 | MUCINEX | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2002-12-18 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021282-001 | MUCINEX | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2002-07-12 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021282-002 | MUCINEX | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2002-12-18 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021282-001 | MUCINEX | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2002-07-12 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021282-002 | MUCINEX | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2002-12-18 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021282-001 | MUCINEX | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2002-07-12 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021282-002 | MUCINEX | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2002-12-18 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021282-001 | MUCINEX | 600MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2002-07-12 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021282-002 | MUCINEX | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2002-12-18 | 74a2ff9319b5… |
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021282-001 | 6372252 | 2020-04-28 | U-489 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021282-001 | 6955821 | 2020-04-28 | U-489 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021282-001 | 7838032 | 2020-04-28 | Drug product | 2010-12-21 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021282-002 | 6372252 | 2020-04-28 | U-489 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021282-002 | 6955821 | 2020-04-28 | U-489 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021282-002 | 7838032 | 2020-04-28 | Drug product | 74a2ff9319b5… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021282-001 | 6372252 | 2020-04-28 | U-489 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021282-001 | 6955821 | 2020-04-28 | U-489 | Drug product | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | N021282-001 | 7838032 | 2020-04-28 | Drug product | 2010-12-21 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | N021282-002 | 6372252 | 2020-04-28 | U-489 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021282-002 | 6955821 | 2020-04-28 | U-489 | Drug product | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | N021282-002 | 7838032 | 2020-04-28 | Drug product | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021282-001 | 6372252 | 2020-04-28 | U-489 | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021282-001 | 6955821 | 2020-04-28 | U-489 | Drug product | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | N021282-001 | 7838032 | 2020-04-28 | Drug product | 2010-12-21 | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | N021282-002 | 6372252 | 2020-04-28 | U-489 | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021282-002 | 6955821 | 2020-04-28 | U-489 | Drug product | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | N021282-002 | 7838032 | 2020-04-28 | Drug product | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021282-001 | 6372252 | 2020-04-28 | U-489 | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021282-001 | 6955821 | 2020-04-28 | U-489 | Drug product | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021282-001 | 7838032 | 2020-04-28 | Drug product | 2010-12-21 | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021282-002 | 6372252 | 2020-04-28 | U-489 | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021282-002 | 6955821 | 2020-04-28 | U-489 | Drug product | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021282-002 | 7838032 | 2020-04-28 | Drug product | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021282-001 | 6372252 | 2020-04-28 | U-489 | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021282-001 | 6955821 | 2020-04-28 | U-489 | Drug product | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N021282-001 | 7838032 | 2020-04-28 | Drug product | 2010-12-21 | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N021282-002 | 6372252 | 2020-04-28 | U-489 | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021282-002 | 6955821 | 2020-04-28 | U-489 | Drug product | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N021282-002 | 7838032 | 2020-04-28 | Drug product | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021282-001 | 6372252 | 2020-04-28 | U-489 | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021282-001 | 6955821 | 2020-04-28 | U-489 | Drug product | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | N021282-001 | 7838032 | 2020-04-28 | Drug product | 2010-12-21 | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | N021282-002 | 6372252 | 2020-04-28 | U-489 | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021282-002 | 6955821 | 2020-04-28 | U-489 | Drug product | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | N021282-002 | 7838032 | 2020-04-28 | Drug product | ea99ee380514… |
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 |
|---|---|---|---|---|---|---|
| 4c4c6cdb-d31b-4f1c-abc0-678278a1f078 | f363cd68-ef6c-4de3-8e9d-2ae4a4fc2fda | 2018-11-15 | Warnings | 4c4c6cdb-d31b-4f1c-abc0-678278a1f078 f363cd68-ef6c-4de3-8e9d-2ae4a4fc2fda |
Adverse event summaries are temporarily unavailable. Other product information remains available.