Indications and uses
Temporary symptomatic relief from congested chests and cough.
Guaifenesin Caplets, 400 mg
- Manufacturer
- Zennova LLC | Zennova Pharmaceuticals (chengdu) Co.,ltd.
- Effective date
- 2026-10-14
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- daily-update
- Hydrated at
- 2026-10-20 03:02:53
Label at a glance#
ProductGuaifenesin
Active ingredientGUAIFENESIN
Label structure11 sections
Dosage and administration
Adults and children 12 years of age and over: take 1 tablet a day. children under 12 years : do not use. Do not exceed 4 doses in 24 hours.
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each tablet)
Guaifenesin 400 mg
Purpose
Expectorant
Uses
Temporary symptomatic relief from congested chests and cough.
Warnings
A persistent cough maybe a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache, consult a doctor.
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
if cough lasts more than 7 days, please consult your physician or healthcare provider.
When using this product
- Do not exceed recommended dosage.
- Do not consume alcohol, benzodiazepines or opioids.
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.
IF PREGNANT OR BREAST-FEEDING
ask a health professional before use
Directions:
- Adults and children 12 years of age and over: take 1 tablet a day.
- children under 12 years: do not use.
- Do not exceed 4 doses in 24 hours.
Questions or Comments
Call toll free 1-888-572-7085, 8.30 am-4.30 pm ET, Monday - Friday
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
OTHER INFORMATION
- Store at 25°C (77°F) excursions between 15°-30°C (59°-86°F).
- Keep in a dry place and do not expose to heat.
- Read all product information before use.
- TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Inactive ingredients
Maltodextrin, Povidone K30, Colloidal Silicon Dioxide, Silicon Dioxide, Stearic Acid
Principal Display Panel
100 ct Labeling
300 ct labeling
Products#
Every source-derived product name is available through these pages.
- Guaifenesin
- Guaifenesin 400 mg
- MALTODEXTRIN
- POVIDONE K30
- SILICON DIOXIDE
- STEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 81993-002 | 81993-002-01, 81993-002-02, 81993-002-03, 81993-002-04, 81993-002-05 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GUAIFENESIN | 495W7451VQ | ACTIB |
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 2 | 2026-09-25 | daily-update | 2026-10-06 02:04:40 |
| 1 | 2026-09-22 | daily-update | 2026-09-25 02:01:38 |
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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.