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 or 2 tablets every 12 hours. Do not exceed 4 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 600 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: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
| Class | Version | Type | Effective |
|---|---|---|---|
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| 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 |
|---|---|---|---|---|---|
| 0363-0071-20 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-4c76-a910-e053-dadaa90a0b85 | Mucus Extended Release |
| 0363-0071-40 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-4c76-a910-e053-dadaa90a0b85 | Mucus Extended Release |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-0071-20 | Mucus | 20 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 20 | 3 | |
| 0363-0071-20 | Mucus | 1 in 1 CARTON | TABLET, EXTENDED RELEASE | 1 | 3 | |
| 0363-0071-40 | Mucus | 2 in 1 CARTON | TABLET, EXTENDED RELEASE | 2 | 3 | |
| 0363-0071-40 | Mucus | 20 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 20 | 3 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0363-0071-20 | EA - Each | 0363-0071 | d9a27ee8-83b0-4eb0-9296-570f9d54268e | 1 | 2020-02-13 |
| 0363-0071-40 | EA - Each | 0363-0071 | dd03f476-3813-4b87-ace6-0ec10daacf7f | 1 | 2022-06-06 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0363-0071 | 0363-0071-20, 0363-0071-40 |
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 |
|---|---|---|---|---|---|---|
| ba020a95-8c4d-4481-9968-c8ed080b25ce | 06b64931-82ac-4d40-acab-17befbe7e868 | 2018-11-05 | Warnings | ba020a95-8c4d-4481-9968-c8ed080b25ce 06b64931-82ac-4d40-acab-17befbe7e868 |
Adverse event summaries are temporarily unavailable. Other product information remains available.