Storage and handling
Other information • store at 20-25°C (68-77°F)
Other information • store at 20-25°C (68-77°F)
For 600 mg:
Active ingredient (in each extended-release tablet)
Guaifenesin, USP 600 mg
For 1200 mg:
Active ingredient (in each extended-release tablet)
Guaifenesin, USP 1200 mg
Purpose
Expectorant
Uses
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Do not use
• for children under 12 years of age
Ask a doctor before use if you have
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• cough accompanied by too much phlegm (mucus)
Stop use and ask a doctor if
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 (1-800-222-1222) right away.
Directions
For 600 mg
• 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 12 years of age and over: 1 or 2 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
For 1200 mg
• 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 12 years of age and over: 1 extended - release tablet every 12 hours. Do not exceed 2 extended - release tablets in 24 hours.
• children under 12 years of age: do not use
Other information
• store at 20-25°C (68-77°F)
Inactive ingredients colloidal silicon dioxide, copovidone, FD&C Blue No. 1 Aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone (K-30), sodium starch glycolate, stearic acid
Questions or comments?
Call 1-877-376-4271 (weekdays 9 AM to 5 PM)
You may also report side effects to this phone number.
Manufactured for:
Time-Cap Labs, Inc.
7 Michael Avenue,
Farmingdale,
NY 11735, USA
Manufactured by:
Marksans Pharma Ltd.
Plot No. L-82, L-83
Verna Indl. Estate
Verna, Goa-403722, India
NDC: 25000-042-55
Guaifenesin Extended-Release Tablets 600 mg
20's count (2 x 10's blister) Carton

NDC: 25000-042-01
Guaifenesin Extended-Release Tablets 600 mg
20's count Bottle Label

NDC: 25000-042-01
Guaifenesin Extended-Release Tablets 600 mg
20's count Bottle Carton

NDC: 25000-042-12
Guaifenesin Extended-Release Tablets 600 mg
500's count Bottle Label

NDC: 25000-042-99
Guaifenesin Extended-Release Tablets 600 mg
40's count (2 x 20's blister) Carton

NDC: 25000-041-75
Guaifenesin Extended-Release Tablets 1200 mg
12's count (2 x 6's blister) Carton

NDC: 25000-041-12
Guaifenesin Extended-Release Tablets 1200 mg
500's count Bottle Label

NDC: 25000-041-34
Guaifenesin Extended-Release Tablets 1200 mg
28's count (2 x 14's blister) Carton
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 310621 | guaiFENesin 1200 MG 12HR Extended Release Oral Tablet | PSN | 6 |
| 636522 | guaiFENesin 600 MG 12HR Extended Release Oral Tablet | PSN | 6 |
| 310621 | 12 HR guaifenesin 1200 MG Extended Release Oral Tablet | SCD | 6 |
| 636522 | 12 HR guaifenesin 600 MG Extended Release Oral Tablet | SCD | 6 |
| 310621 | guaifenesin 1200 MG 12 HR Extended Release Oral Tablet | SY | 6 |
| 636522 | guaifenesin 600 MG 12 HR Extended Release Oral Tablet | SY | 6 |
| Class | Version | Type | Effective |
|---|---|---|---|
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0325000041120 | GTIN-13: 0325000041120 EAN-13: 0325000041120 GTIN-12: 325000041120 UPC-A: 325000041120 GTIN storage (14 digits): 00325000041120 | guaifenesin-1200mg-bottle-label-500s.jpg |
| Barcode | EAN-13 | 0325000041342 | GTIN-13: 0325000041342 EAN-13: 0325000041342 GTIN-12: 325000041342 UPC-A: 325000041342 GTIN storage (14 digits): 00325000041342 | guaifenesin-1200mg-blisters-ifc-28s.jpg |
| Barcode | EAN-13 | 0325000041755 | GTIN-13: 0325000041755 EAN-13: 0325000041755 GTIN-12: 325000041755 UPC-A: 325000041755 GTIN storage (14 digits): 00325000041755 | guaifenesin-1200mg-12s-blisterifc.jpg |
| Barcode | EAN-13 | 0325000042011 | GTIN-13: 0325000042011 EAN-13: 0325000042011 GTIN-12: 325000042011 UPC-A: 325000042011 GTIN storage (14 digits): 00325000042011 | guaifenesin-600mg-bottle-ifc-20s.jpg |
| Barcode | EAN-13 | 0325000042127 | GTIN-13: 0325000042127 EAN-13: 0325000042127 GTIN-12: 325000042127 UPC-A: 325000042127 GTIN storage (14 digits): 00325000042127 | guaifenesin-600mg-bottle-label-500s.jpg |
| Barcode | EAN-13 | 0325000042554 | GTIN-13: 0325000042554 EAN-13: 0325000042554 GTIN-12: 325000042554 UPC-A: 325000042554 GTIN storage (14 digits): 00325000042554 | guaifenesin-600mg-blister-ifc20s.jpg |
| Barcode | EAN-13 | 0325000042998 | GTIN-13: 0325000042998 EAN-13: 0325000042998 GTIN-12: 325000042998 UPC-A: 325000042998 GTIN storage (14 digits): 00325000042998 | guaifenesin-600mg-blister-ifc-40s.jpg |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 25000-041-12 | Guaifenesin 1200 mg | 500 in 1 BOTTLE | TABLET | 500 | 6 | |
| 25000-041-34 | Guaifenesin 1200 mg | 2 in 1 CARTON | TABLET | 2 | 6 | |
| 25000-041-34 | Guaifenesin 1200 mg | 14 in 1 BLISTER PACK | TABLET | 14 | 6 | |
| 25000-041-75 | Guaifenesin 1200 mg | 2 in 1 CARTON | TABLET | 2 | 6 | |
| 25000-041-75 | Guaifenesin 1200 mg | 6 in 1 BLISTER PACK | TABLET | 6 | 6 | |
| 25000-042-01 | Guaifenesin 600 mg | 20 in 1 BOTTLE | TABLET | 20 | 6 | |
| 25000-042-01 | Guaifenesin 600 mg | 1 in 1 CARTON | TABLET | 1 | 6 | |
| 25000-042-12 | Guaifenesin 600 mg | 500 in 1 BOTTLE | TABLET | 500 | 6 | |
| 25000-042-55 | Guaifenesin 600 mg | 2 in 1 CARTON | TABLET | 2 | 6 | |
| 25000-042-55 | Guaifenesin 600 mg | 10 in 1 BLISTER PACK | TABLET | 10 | 6 | |
| 25000-042-99 | Guaifenesin 600 mg | 2 in 1 CARTON | TABLET | 2 | 6 | |
| 25000-042-99 | Guaifenesin 600 mg | 20 in 1 BLISTER PACK | TABLET | 20 | 6 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 25000-041 | 25000-041-75, 25000-041-12, 25000-041-34 |
| 25000-042 | 25000-042-55, 25000-042-01, 25000-042-12, 25000-042-99 |
Every source-derived ingredient row is available through these pages.
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 4 | 2025-03-18 | full-release | 2026-06-01 00:59:45 |
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 |
|---|---|---|---|---|---|---|---|
| A217780-001 | GUAIFENESIN | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2023-08-21 | ||
| A217780-002 | GUAIFENESIN | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2023-08-21 |
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 | A217780-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2023-08-21 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A217780-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2023-08-21 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A217780-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2023-08-21 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A217780-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2023-08-21 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A217780-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2023-08-21 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A217780-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2023-08-21 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217780-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2023-08-21 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217780-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2023-08-21 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A217780-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2023-08-21 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A217780-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2023-08-21 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217780-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2023-08-21 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217780-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2023-08-21 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217780-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2023-08-21 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217780-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2023-08-21 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217780-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2023-08-21 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217780-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2023-08-21 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217780-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2023-08-21 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217780-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2023-08-21 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217780-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2023-08-21 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217780-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2023-08-21 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217780-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2023-08-21 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217780-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2023-08-21 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A217780-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2023-08-21 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A217780-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2023-08-21 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217780-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2023-08-21 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217780-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2023-08-21 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217780-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2023-08-21 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217780-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2023-08-21 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217780-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2023-08-21 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217780-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2023-08-21 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A217780-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2023-08-21 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A217780-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2023-08-21 | 8072bd15b7f6… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A217780-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2023-08-21 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A217780-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2023-08-21 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A217780-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2023-08-21 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A217780-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2023-08-21 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A217780-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2023-08-21 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A217780-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2023-08-21 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A217780-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2023-08-21 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A217780-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2023-08-21 | a72a2bbeb626… |
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 1200 mg | GUAIFENESIN 1200 MG | MARKSANS PHARMA LIMITED | fedf43d0-d6d1-4f50-bbab-396701e45cb2 | 2025-10-17 | Warnings | 25000-041-75 25000-041-34 25000-041-12 25000-042-55 25000-042-99 25000-042-12 25000-042-01 25000-042 25000-041 25000004112 25000004134 25000004212 25000004299 25000004175 25000004255 25000004201 0af3bdb4-c1f3-4941-a1de-6e08c49849cb fedf43d0-d6d1-4f50-bbab-396701e45cb2 |
Adverse event summaries are temporarily unavailable. Other product information remains available.