Indications and uses
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Guaifenesin Extended-Release Tablets, 600 mg and 1200 mg
- Manufacturer
- Granules India Ltd | Ganules India Limited
- Effective date
- 2026-10-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 9
- Source
- daily-update
- Hydrated at
- 2026-10-10 01:03:41
Label at a glance#
ProductGUAIFENESIN
Active ingredientGUAIFENESIN
Label structure15 sections
Dosage and administration
do not crush, chew, or break extended-release tablet take with a full glass of water this product can be administered without regard for 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 (For 600 mg) adults and children 12 years of age and over: 1 extended-release tablet every 12 hours. Do not exceed 2 ...
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients (in each extended-release tablet)
Guaifenesin 600 mg (for 600 mg)
Guaifenesin 1200 mg (for 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
Warnings
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
- cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.
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)
Directions
- do not crush, chew, or break extended-release tablet
- take with a full glass of water
- this product can be administered without regard for 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 (For 600 mg)
- 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. (For 1200 mg)
- children under 12 years of age: do not use
Other information
- 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)
Inactive ingredients
carbomer homopolymer type B; hypromellose; magnesium stearate; microcrystalline cellulose; sodium starch glycolate
Questions?
Contact 1-877-770-3183
Mon-Fri 8:00 AM EST to 5:00 PM PST.
PRINCIPAL DISPLAY PANEL - 600 mg Blister Carton Label
NDC 62207-
839-72
Compare to the active ingredient
of Mucinex
®
Guaifenesin
Extended-Release Tablets 600 mg
Guaifenesin 600 mg - Expectorant
RELIEVES CHEST CONGESTION
12HR FOR DAY •
Relieves Chest Congestion
OR NIGHT •
Thins and Loosens Mucus
•
Immediate and Extended Release
90 (9 x 10) EXTENDED-RELEASE TABLETS
PRINCIPAL DISPLAY PANEL - 1200 mg Blister Carton Label
NDC 62207-
840-71
Compare to the active ingredient
of Mucinex
®
Guaifenesin
Extended-Release Tablets 1200 mg
Maximum strength
Guaifenesin 1200 mg - Expectorant
RELIEVES CHEST CONGESTION
12HR FOR DAY • Relieves Chest Congestion
OR NIGHT • Thins and Loosens Mucus
• Immediate and Extended Release
70 (7 x 10) EXTENDED-RELEASE TABLETS
PRINCIPAL DISPLAY PANEL
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0362207839723 | GTIN-13: 0362207839723 EAN-13: 0362207839723 GTIN-12: 362207839723 UPC-A: 362207839723 GTIN storage (14 digits): 00362207839723 | guaifenesin-600mg-carton.jpg |
| Barcode | EAN-13 | 0362207840712 | GTIN-13: 0362207840712 EAN-13: 0362207840712 GTIN-12: 362207840712 UPC-A: 362207840712 GTIN storage (14 digits): 00362207840712 | guaifenesin-1200mg-carton.jpg |
Products#
Every source-derived product name is available through these pages.
- GUAIFENESIN
- HYPROMELLOSE 2910 (5 MPA.S)
- CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- HYPROMELLOSE 2910 (10000 MPA.S)
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 62207-839 | 62207-839-72 |
| 62207-840 | 62207-840-71, 62207-840-99, 62207-840-93 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 8 | 2025-12-02 | full-release | 2026-06-01 01:19:10 |
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A213420-001 | GUAIFENESIN | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | ||
| A213420-002 | GUAIFENESIN | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 |
Observed Orange Book product history#
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 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | 4b0b4de00fa7… |
openFDA label cross-check#
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 |
|---|---|---|---|---|---|---|
| 44f3065d-0001-622b-e063-6394a90a2775 | e3531e9e-2ae7-4188-b95a-90f35613fc05 | 2025-12-02 | Warnings | e3531e9e-2ae7-4188-b95a-90f35613fc05 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.