Active ingredient (in each soft gelatin capsule)
Guaifenesin USP 400mg
Dextromethorphan HBr USP 20mg
Guaifenesin USP 400mg
Dextromethorphan HBr USP 20mg
Purposes
Expectorant
Cough suppressant
Uses
Warnings
Do not use
Ask a doctor before use if you have
Stop use and ask a doctor if
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Directions
Other information
Inactive ingredients
gelatin, glycerin, polyethylene glycol 400, povidone k-30,propylene glycol, purified water, sorbitol sorbitan solution
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| 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 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 35916-0759-3 | Guaifenesin,Dextromethorphan Hbr | 2000 in 1 POUCH | CAPSULE, LIQUID FILLED | 2000 | 4 | |
| 35916-0759-3 | Guaifenesin,Dextromethorphan Hbr | 2 in 1 BOX | CAPSULE, LIQUID FILLED | 2 | 4 | |
| 35916-0759-4 | Guaifenesin,Dextromethorphan Hbr | 2 in 1 BOX | CAPSULE, LIQUID FILLED | 2 | 4 | |
| 35916-0759-4 | Guaifenesin,Dextromethorphan Hbr | 1500 in 1 BAG | CAPSULE, LIQUID FILLED | 1500 | 4 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 35916-0759 | 35916-0759-3, 35916-0759-4 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GLYCERIN | PDC6A3C0OX | IACT |
| WATER | 059QF0KO0R | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| GELATIN | 2G86QN327L | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| SORBITOL | 506T60A25R | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 3 | 2026-01-14 | monthly-update | 2026-06-03 17:52:57 |
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,Dextromethorphan Hbr | GUAIFENESIN,DEXTROMETHORPHAN HBR | Softgel Healthcare Pvt Ltd | 3e5d978f-cc70-60a5-e063-6394a90a67d3 | 2026-04-27 | Warnings | 35916-0759-3 35916-0759-4 35916-0759 35916075903 35916075904 50032ae7-88ff-59ad-e063-6394a90a45c2 3e5d978f-cc70-60a5-e063-6394a90a67d3 |
Adverse event summaries are temporarily unavailable. Other product information remains available.