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
- Manufacturer
- GRANULES USA, INC.
- Effective date
- 2025-12-22
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- full-release
- Hydrated at
- 2026-06-01 01:27:58
Label at a glance#
ProductGuaifenesin
Active ingredientGUAIFENESIN
Label structure13 sections
Dosage and administration
do not crush, chew, or break 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 tablet every 12 hours. Do not exceed 2 tablets in 24 hours children under 12 years of age: do not use
Storage and handling
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)
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients (in each extended-release bi-layer tablet)
Guaifenesin 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
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 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 tablet every 12 hours. Do not exceed 2 tablets in 24 hours
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
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
DailyMed Product Concepts#
| 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69848-018-16 | Guaifenesin | 14 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 14 | 7 |
Products#
Every source-derived product name is available through these pages.
- Guaifenesin
- SODIUM STARCH GLYCOLATE TYPE A
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- HYPROMELLOSE 2910 (5 MPA.S)
- CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69848-018 | 69848-018-16 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM STARCH GLYCOLATE TYPE A | H8AV0SQX4D | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| HYPROMELLOSE 2910 (5 MPA.S) | R75537T0T4 | IACT |
| CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) | Z135WT9208 | IACT |
| GUAIFENESIN | 495W7451VQ | ACTIB |
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 |
|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 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… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A213420-001 | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A213420-002 | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE / ORAL | 2020-05-08 | bb7c543d1eb4… |
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 | GRANULES USA, INC. | a62e2045-8ec2-1771-e053-2995a90a03b4 | 2025-12-22 | Warnings | 69848-018-16 69848-018 69848001816 469099a1-3de3-d107-e063-6294a90adf16 a62e2045-8ec2-1771-e053-2995a90a03b4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.