Indications and uses
helps loosen phelgm (mucus) and thin bronchial secretions to make coughs more productive to rid the bronchial passageway of bothersome mucus
987 Guaifenesin 400mg tablet
- Manufacturer
- Medline Industries, LP
- Effective date
- 2021-11-16
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:27:07
Label at a glance#
ProductGuaifenesin 400mg
Active ingredientGUAIFENESIN
Label structure9 sections
Dosage and administration
adults and children 12 years of age and older: take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours. Children under 12 years of age: do not use
Label contents#
Full prescribing information#
Active ingredient (in each immediate-release tablet)
Guaifenesin 400 mg
Purpose
Expectorant
Uses
- helps loosen phelgm (mucus) and thin bronchial secretions to make coughs more productive to rid the bronchial passageway of bothersome mucus
Warnings
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 excessive phlegm (mucus)
When using this product
- do not exceed recommend dosage
- do not use for more than 7 days
Stop use and ask a doctor if
- cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
If pregnant or breast-feeding,
ask a healthcare professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- adults and children 12 years of age and older: take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.
- Children under 12 years of age: do not use
Other information
- store at 25 degrees Celsius (77 degrees Fahrenheit) excursions permitted between 15 degrees to 30 degrees Celsius (fifty nine degrees to eighty six degrees Fahrenheit)
- keep in a dry place and do not expose to excessive heat
Inactive ingredients
collodial silicon dioxide, magnesium stearate, maltodextrin, microcrystallline cellulose, povidone, silicon dioxide, sodium starch glycolate, stearic acid
Questions or comments?
Call toll free 1-800-MEDLINE (633-5463)
Monday-Friday 9AM-5PM CST
Package Label
Products#
Every source-derived product name is available through these pages.
- Guaifenesin 400mg
- guaifenesin
- MICROCRYSTALLINE CELLULOSE
- STEARIC ACID
- SILICON DIOXIDE
- MAGNESIUM STEARATE
- MALTODEXTRIN
- POVIDONE
- SODIUM STARCH GLYCOLATE TYPE A POTATO
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 53329-987 | 53329-987-62 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| POVIDONE | FZ989GH94E | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
Source Document#
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 |
|---|---|---|---|---|---|---|
| d0ebaa5d-81d4-15a6-e053-2995a90a24f3 | 6cd11814-c707-1b74-e053-2991aa0a0619 | 2021-11-16 | Warnings | d0ebaa5d-81d4-15a6-e053-2995a90a24f3 6cd11814-c707-1b74-e053-2991aa0a0619 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.