Active ingredient (in each soft gelatin capsule)
Dextromethorphan HBr USP 10mg
Guaifenesin USP 200mg
Dextromethorphan HBr USP 10mg
Guaifenesin USP 200mg
Purposes
Cough suppresent
Expectorant
Uses
Warnings
Do not use
Ask a doctor before use if you have
When using this product do not use more than directed
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 overdose, get medical help or contact a poison control center right away.
Directions
Other information
Inactive ingredients
D&C yellow 10, FD&C blue 1, gelatin, glycerin, polyethylene glycol 400, povidone k-30, purified water, sorbitol sorbitan solution, titanium dioxide
| 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 |
| 6084a4f4-5437-c9a5-caec-5361ee075a59 | Product name | 1 | 20140508 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
| 90c5639a-61b0-88d6-ddcf-21888e94869a | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 35916-0760-1 | Dextromethorphan Hbr,Guaifenesin | 1000 in 1 BAG | CAPSULE, LIQUID FILLED | 1000 | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 35916-0760 | 35916-0760-1 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GLYCERIN | PDC6A3C0OX | IACT |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| SORBITOL | 506T60A25R | IACT |
| WATER | 059QF0KO0R | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| GELATIN | 2G86QN327L | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
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 |
|---|---|---|---|---|---|---|
| Dextromethorphan Hbr,Guaifenesin | DEXTROMETHORPHAN HBR,GUAIFENESIN | SOFTGEL HEALTHCARE PRIVATE LIMITED | 2fbbfc7c-81a9-b647-e063-6394a90a55ac | 2026-01-27 | Warnings | 35916-0760-1 35916-0760 35916076001 47b53021-eb30-c736-e063-6294a90ae369 2fbbfc7c-81a9-b647-e063-6394a90a55ac |
Adverse event summaries are temporarily unavailable. Other product information remains available.