Storage and handling
Other information store at 20-25°C (68-77°F)
Kroger Guaifenesin Extended Release Tablets 1200 mg
- Manufacturer
- KROGER COMPANY | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
- Effective date
- 2024-05-25
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 00:12:59
Label at a glance#
ProductMaximum Strength Mucus Relief
Active ingredientGUAIFENESIN
Label structure9 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each extended-release tablet)
Guaifenesin, USP 1200 mg
OTC - PURPOSE SECTION
Purpose
Expectorant
INDICATIONS & USAGE SECTION
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Warnings
OTC - DO NOT USE SECTION
Do not use
- for children under 12 years of age
OTC - ASK DOCTOR SECTION
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)
OTC - STOP USE SECTION
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.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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.
DOSAGE & ADMINISTRATION SECTION
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
STORAGE AND HANDLING SECTION
Other information
- store at 20-25°C (68-77°F)
INACTIVE INGREDIENT SECTION
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.
OTC - QUESTIONS SECTION
Questions or comments? Call 1-800-632-6900
PACKAGE LABEL.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 |
|---|---|---|---|---|---|---|
| 41226-724-89 | Maximum Strength Mucus Relief | 14 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 14 | 2 | |
| 41226-724-89 | Maximum Strength Mucus Relief | 1 in 1 CARTON | TABLET, EXTENDED RELEASE | 1 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Maximum Strength Mucus Relief
- Guaifenesin
- HYPROMELLOSE, UNSPECIFIED
- MICROCRYSTALLINE CELLULOSE 102
- STEARIC ACID
- FD&C BLUE NO. 1 ALUMINUM LAKE
- SODIUM STARCH GLYCOLATE TYPE A
- MALTODEXTRIN
- POVIDONE K30
- SILICON DIOXIDE
- COPOVIDONE K25-31
- MAGNESIUM STEARATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 41226-724 | 41226-724-89 |
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 |
|---|---|---|---|---|---|---|---|
| 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 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 | 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 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 |
|---|---|---|---|---|---|---|
| Maximum Strength Mucus Relief | GUAIFENESIN | KROGER COMPANY | 100ff8e2-88ed-0e8c-e063-6294a90a5716 | 2024-05-25 | Warnings | 41226-724-89 41226-724 41226072489 194317de-d799-b556-e063-6394a90acff7 100ff8e2-88ed-0e8c-e063-6294a90a5716 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.