Indications and uses
Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bronchial mucus and make coughs more productive
Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bronchial mucus and make coughs more productive
do not crush, chew or break extended-release tablet take with a full glass of water this product can be administered without regard for the timing of meals adults and children over 12 years of age and over: one or two extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours. children under 12 years of age: do not use. Other information store between 20-25°C (68-77°F) TAMPER EVI...
(in each extended-release tablet)
Guaifenesin, USP
Expectorant
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Do not use
Ask a doctor before use if you have
Stop use and ask a doctor if
If pregnant or breast-feeding,ask a health professional before use.
Other information
colloidal silicon dioxide, FD&C blue # 2, aluminum lake, hypromellose, magnesium stearate, povidone.
call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984.
Keep the carton. It contains important information. See end panel for expiration date.
†OHM and OHM Logo are trademarks of Ohm Laboratories, Inc. All other trademarks are the property of their respective owners.
Distributed by:
Ohm Laboratories Inc.
New Brunswick, NJ 08901
PRODUCT OF INDIA
R0425
CODE No.: PB/DRUGS/1809-0SP
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 310621 | guaiFENesin 1200 MG 12HR Extended Release Oral Tablet | PSN | 4 |
| 636522 | guaiFENesin 600 MG 12HR Extended Release Oral Tablet | PSN | 4 |
| 310621 | 12 HR guaifenesin 1200 MG Extended Release Oral Tablet | SCD | 4 |
| 636522 | 12 HR guaifenesin 600 MG Extended Release Oral Tablet | SCD | 4 |
| 310621 | guaifenesin 1200 MG 12 HR Extended Release Oral Tablet | SY | 4 |
| 636522 | guaifenesin 600 MG 12 HR Extended Release Oral Tablet | SY | 4 |
| 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 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51660-566-21 | Guaifenesin | 20 in 1 CARTON | TABLET, EXTENDED RELEASE | 20 | 4 | |
| 51660-566-41 | Guaifenesin | 40 in 1 CARTON | TABLET, EXTENDED RELEASE | 40 | 4 | |
| 51660-566-68 | Guaifenesin | 68 in 1 CARTON | TABLET, EXTENDED RELEASE | 68 | 4 | |
| 51660-567-54 | Guaifenesin | 14 in 1 CARTON | TABLET, EXTENDED RELEASE | 14 | 4 | |
| 51660-567-58 | Guaifenesin | 56 in 1 CARTON | TABLET, EXTENDED RELEASE | 56 | 4 | |
| 51660-567-86 | Guaifenesin | 28 in 1 CARTON | TABLET, EXTENDED RELEASE | 28 | 4 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51660-566-21 | EA - Each | 51660-566 | 4620bf8a-cf82-4184-a8c7-09086b0012f5 | 1 | 2023-08-08 |
| 51660-567-86 | EA - Each | 51660-567 | f0b32da4-bab4-45e9-be5c-a1d7d159d4ef | 1 | 2025-09-12 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 51660-566 | 51660-566-41, 51660-566-21, 51660-566-68 |
| 51660-567 | 51660-567-54, 51660-567-86, 51660-567-58 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| FD&C BLUE NO. 2 | L06K8R7DQK | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| POVIDONE, UNSPECIFIED | FZ989GH94E | IACT |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| FD&C BLUE NO. 2 | L06K8R7DQK | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| POVIDONE, UNSPECIFIED | FZ989GH94E | IACT |
| GUAIFENESIN | 495W7451VQ | ACTIB |
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 |
|---|---|---|---|---|---|---|---|
| A209254-001 | GUAIFENESIN | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-16 | ||
| A209254-002 | GUAIFENESIN | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-16 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A209254-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-16 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A209254-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-16 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A209254-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-16 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A209254-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-16 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A209254-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A209254-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-16 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A209254-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A209254-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-16 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209254-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209254-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-16 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A209254-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-16 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A209254-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-16 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209254-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-16 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209254-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-16 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209254-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-16 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209254-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-16 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209254-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-16 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209254-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-16 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209254-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-16 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209254-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-16 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209254-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-16 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209254-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-16 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209254-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-16 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209254-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-16 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A209254-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-16 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A209254-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-16 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209254-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-16 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209254-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-16 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209254-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-16 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209254-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-16 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209254-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-16 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209254-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-16 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A209254-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-16 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A209254-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-16 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209254-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-16 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209254-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-16 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A209254-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-16 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A209254-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-16 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A209254-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2018-07-16 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A209254-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2018-07-16 | 4b0b4de00fa7… |
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 |
|---|---|---|---|---|---|---|
| Guaifenesin | GUAIFENESIN | Ohm Laboratories, Inc. | 7076e42a-17ff-4c42-9963-2dc02c0a5e49 | 2026-02-12 | Warnings | 51660-567-86 51660-567-54 51660-566-41 51660-566-68 51660-567-58 51660-566-21 51660-566 51660-567 51660056758 51660056641 51660056621 51660056786 51660056668 51660056754 4aa4fb35-6f33-6e33-e063-6394a90a495e 7076e42a-17ff-4c42-9963-2dc02c0a5e49 |
Adverse event summaries are temporarily unavailable. Other product information remains available.