OTC - ACTIVE INGREDIENT SECTION
Dextromethorphan HBr 20mg
Guaifenesin 400mg
Dextromethorphan HBr 20mg
Guaifenesin 400mg
Cough suppressant
Expectorant
FD&C yellow #10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide.
Do not take more than directed – See overdose warning
Do not use for more than 7 days
Do not take more than 6 doses in 24 hours
Adults and children 12 years of age and over: take 1 softgel every 4 hours with a full glass of water while symptoms persist
Children under 12 years of age: do not use
Helps loosen phlegm (mucus)
Helps thin bronchial secretions to make coughs more productive
Do not use:
Ask a doctor before use if you have:
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 health professional before use.
Keep out of reach of children.
Keep out of reach of children
OVERDOSE WARNING: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
store at room temperature between 20-25°C (68-77ºF)
avoid excessive heat and humidity
| 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 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69729-781-02 | 2024-04-02 | C162847 | 48780-1 | d6a99b39-b1b9-a426-e053-dadaa90af4c2 | Pentrexcilina Expectorant & Cough Suppressant |
| 69729-781-02 | 2024-01-30 | C162847 | 48780-1 | d6a99b39-b1b9-a426-e053-dadaa90af4c2 | Pentrexcilina Expectorant & Cough Suppressant |
| 69729-781-02 | 2022-04-12 | C162847 | 48780-1 | d6a99b39-b1b9-a426-e053-dadaa90af4c2 | Pentrexcilina Expectorant & Cough Suppressant |
| 69729-781-02 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-b1b9-a426-e053-dadaa90af4c2 | Pentrexcilina Expectorant & Cough Suppressant |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69729-781-02 | DEXTROMETHORPHAN HBR, GUAIFENESIN | 20 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 20 | 7 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69729-781 | 69729-781-02 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SORBITOL | 506T60A25R | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| GELATIN | 2G86QN327L | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| SORBITAN | 6O92ICV9RU | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| GUAIFENESIN | 495W7451VQ | 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 | OPMX LLC | 9a16e7f3-78aa-0b01-e053-2a95a90ab19c | 2024-04-05 | Warnings | 69729-781-02 69729-781 69729078102 155b8919-8006-caa9-e063-6394a90a876b 9a16e7f3-78aa-0b01-e053-2a95a90ab19c |
Adverse event summaries are temporarily unavailable. Other product information remains available.