Guaifenesin Tablets, USP 400 mg
- Manufacturer
- Health Pharma USA LLC | Elysium Pharmaceuticals Ltd. | HHH Pharmaceuticals
- Effective date
- 2025-12-05
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 01:20:14
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each caplet)
Guaifenesin 400 mg
OTC - PURPOSE SECTION
Purpose
Expectorant
INDICATIONS & USAGE SECTION
Uses
- Temporary symptomatic relief from congested chests and cough.
WARNINGS SECTION
Warnings
A persistent cough may be 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.
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 excessive phlegm (mucus).
OTC - WHEN USING SECTION
When using this product
- Do not exceed recommended dosage.
- Do not consume alcohol, benzodiazepines or opioids.
OTC - STOP USE SECTION
Stop use and ask a doctor if
cough lasts for more than 7 days please consult your physician or healthcare provider.
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
- Adults and children 12 years of age and over:take 1 caplet a day.
- Children under 12 years:Do not use.
- Do not exceed 4 doses in 24 hours.
OTHER SAFETY INFORMATION
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 INGREDIENT SECTION
Inactive ingredients
Croscarmellose sodium, Maltodextrin, PVP K30, Silicon dioxide, Microcrystalline cellulose, stearic acid, Purified water.
OTC - QUESTIONS SECTION
Questions or comments?
Call toll free 1-844-832-1138 Monday through Friday 9AM – 5PM EST
PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0371679309023 | GTIN-13: 0371679309023 EAN-13: 0371679309023 GTIN-12: 371679309023 UPC-A: 371679309023 GTIN storage (14 digits): 00371679309023 | 71679-309-02-MucusRelief-Guai 400mg-200s-FINAL.jpg |
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 71679-309-00 | 2025-12-05 | C162847 | 48780-1 | 3b156c62-32c5-fb37-e063-e6dba90a4e07 | Guaifenesin Tablets, USP 400 mg |
| 71679-309-02 | 2025-12-05 | C162847 | 48780-1 | 3b156c62-32c5-fb37-e063-e6dba90a4e07 | Guaifenesin Tablets, USP 400 mg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71679-309-00 | Guaifenesin | 38500 in 1 BOTTLE | TABLET | 38500 | 5 | |
| 71679-309-02 | Guaifenesin | 200 in 1 BOTTLE | TABLET | 200 | 5 |
Products#
Every source-derived product name is available through these pages.
- Guaifenesin
- MALTODEXTRIN
- CROSCARMELLOSE SODIUM
- WATER
- SILICON DIOXIDE
- CELLULOSE, MICROCRYSTALLINE
- STEARIC ACID
- POVIDONE K30
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 71679-309 | 71679-309-00, 71679-309-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| WATER | 059QF0KO0R | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| GUAIFENESIN | 495W7451VQ | ACTIB |
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 |
|---|---|---|---|---|---|---|
| Guaifenesin | GUAIFENESIN | Health Pharma USA LLC | 31755594-3e1c-b290-e063-6394a90aba61 | 2025-12-05 | Warnings | 71679-309-00 71679-309-02 71679-309 71679030900 71679030902 45395c54-4eb3-fd26-e063-6294a90a9f93 31755594-3e1c-b290-e063-6394a90aba61 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

