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 - Aurohealth LLC | APL HEALTHCARE LIMITED
- Manufacturer
- Aurohealth LLC | APL HEALTHCARE LIMITED
- Effective date
- 2026-07-03
- Label type
- Human OTC Drug Label
- Version
- 1
- Source
- weekly-update
- Hydrated at
- 2026-07-17 21:43:18
Label at a glance#
ProductGuaifenesin
Active ingredientGUAIFENESIN
Label structure13 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 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
Storage and handling
store between 20° to 25°C (68° to 77°F)
Contacts and useful links#
Label contents#
Full prescribing information#
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
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 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 between 20° to 25°C (68° to 77°F)
Inactive ingredients
colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinised starch (maize)
Questions?
1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)
Distributed by:
AUROHEALTH LLC.
279 Princeton-Hightstown Road,
East Windsor, NJ 08520
Made in India
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg Blister Carton (84 (6 x 14) Tablets)
Healthy Living™
Maximum Strength
GUAIFENESIN
extended-release tablets 1200 mg
Guaifenesin 1200 mg - Expectorant
RELIEVES CHEST CONGESTION
- Relieves Chest Congestion
- Thins & Loosens Mucus
12 Hour
*Compare
to the Active
Ingredient in
Maximum
Strength
Mucinex®
84 Extended-Release Tablets
Products#
Every source-derived product name is available through these pages.
- Guaifenesin
- SILICON DIOXIDE
- HYPROMELLOSE 2208 (15000 MPA.S)
- HYPROMELLOSE 2910 (10000 MPA.S)
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE 101
- MICROCRYSTALLINE CELLULOSE 102
- POVIDONE K90
- POVIDONE K25
- STARCH, CORN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58602-857 | 58602-857-93 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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 |
|---|---|---|---|---|---|---|---|
| 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 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 | A210453-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2019-10-21 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A210453-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2019-10-21 | c2088c7a36db… | ||
| 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… |
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 |
|---|---|---|---|---|---|---|
| Guaifenesin | GUAIFENESIN | Aurohealth LLC | 062e3d83-8495-4c8f-b1e6-5eb37fd53224 | 2026-07-03 | Warnings | 58602-857-93 58602-857 58602085793 062e3d83-8495-4c8f-b1e6-5eb37fd53224 062e3d83-8495-4c8f-b1e6-5eb37fd53224 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.