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
store between 20° to 25°C (68° to 77°F) Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing
(in each extended-release tablet)
Guaifenesin USP 1200 mg
Expectorant
Do not use
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).
colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinised starch (maize)
1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) You may also report side effects to this phone number.
DISTRIBUTED BY:
MIDWOOD BRANDS, LLC
500 VOLVO PARKWAY, CHESAPEAKE,
VA 23320
Code: AP/DRUGS/04/2016
Made in India
COMPARE TO THE ACTIVE INGREDIENT
IN MAXIMUM STRENGTH MUCINEX®*
NDC 55319-902-64
FAMILY
Wellness™
MAXIMUM STRENGTH
Mucus Relief
GUAIFENESIN EXTENDED-RELEASE TABLETS
1200 mg, EXPECTORANT
12 69
HOUR ACTUAL SIZE
√ RELIEVES CHEST CONGESTION
√ THINS AND LOOSENS MUCUS
7 EXTENDED-RELEASE TABLETS

Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 55319-902 | 55319-902-64 |
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 |
|---|---|---|---|---|---|---|---|
| A210453-001 | GUAIFENESIN | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2019-10-21 | ||
| A210453-002 | GUAIFENESIN | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2019-10-21 |
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 | A210453-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2019-10-21 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A210453-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2019-10-21 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A210453-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2019-10-21 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A210453-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2019-10-21 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A210453-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2019-10-21 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A210453-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2019-10-21 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210453-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2019-10-21 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210453-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2019-10-21 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A210453-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2019-10-21 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A210453-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2019-10-21 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210453-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2019-10-21 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210453-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2019-10-21 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210453-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2019-10-21 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210453-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2019-10-21 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210453-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2019-10-21 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210453-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2019-10-21 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210453-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2019-10-21 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210453-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2019-10-21 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210453-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2019-10-21 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210453-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2019-10-21 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210453-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2019-10-21 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210453-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2019-10-21 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A210453-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2019-10-21 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A210453-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2019-10-21 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210453-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2019-10-21 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210453-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2019-10-21 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210453-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2019-10-21 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210453-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2019-10-21 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210453-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2019-10-21 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210453-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2019-10-21 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A210453-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2019-10-21 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A210453-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2019-10-21 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210453-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2019-10-21 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210453-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2019-10-21 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A210453-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2019-10-21 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A210453-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2019-10-21 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A210453-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2019-10-21 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A210453-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2019-10-21 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A210453-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2019-10-21 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A210453-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2019-10-21 | 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 |
|---|---|---|---|---|---|---|
| d1d68162-cef0-4ca1-9393-97e0db363d97 | ffb01058-d8b3-4c37-a8bb-bf0302364eb5 | 2022-10-29 | Warnings | d1d68162-cef0-4ca1-9393-97e0db363d97 ffb01058-d8b3-4c37-a8bb-bf0302364eb5 |
Adverse event summaries are temporarily unavailable. Other product information remains available.