do not take more than 8 softgels in any 24-hour period this adult product is not intended for use in children under 12 years of age adults and children 12 years and over take 2 capsules every 6 to 8 hours, as needed children under 12 years do not use
store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F) protect from light
Drug Facts
Dextromethorphan HBr, USP 15mg
Cough suppressant
temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.
Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product
Stop use and ask doctor if cough lasts for more than 7 days, comes back, 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. In case of overdose, get medical help orcontact a Poison Control Center right away.
| adults and children 12 years and over | take 2 capsules every 6 to 8 hours, as needed |
| children under 12 years | do not use |
FD&C red no. 40, gelatin, glycerin, polyethylene glycol 400, propylene glycol, povidone, sorbitol sorbitan, titanium dioxide
1-888-333-9792
Distributed By:
SPIRIT PHARMACEUTICALS LLC.
RONKONKOMA, NY 11779
Compare to the Active Ingredient of
ROBITUSSIN ® LONG ACTING COUGH GELS ©*
VALUMEDS™
ADULT LONG-LASTING
Cough Relief FOR AGES 12 & OVER
Dextromethorphan HBr, 15 mg
Cough suppressant
Relieves cough for up to 8 hours
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68210-0106-1 | DEXTROMETHORPHAN HYDROBROMIDE | 15 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 15 | 8 | |
| 68210-0106-1 | DEXTROMETHORPHAN HYDROBROMIDE | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | 8 | |
| 68210-0106-2 | DEXTROMETHORPHAN HYDROBROMIDE | 240 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 240 | 8 | |
| 68210-0106-2 | DEXTROMETHORPHAN HYDROBROMIDE | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | 8 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68210-0106 | DEXTROMETHORPHAN HYDROBROMIDE CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS LLC] | 8 | Legacy NDC, 4 package rows | 20241215_ac4d581b-4f09-40a0-a75f-d23d9c6fc0b9.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68210-0106 | 68210-0106-1, 68210-0106-2 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| GELATIN | 2G86QN327L | IACT |
| SORBITOL | 506T60A25R | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | 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 |
|---|---|---|---|---|---|---|
| 292d3e11-ff81-09e5-e063-6394a90a0194 | ac4d581b-4f09-40a0-a75f-d23d9c6fc0b9 | 2024-12-13 | Warnings | 292d3e11-ff81-09e5-e063-6394a90a0194 ac4d581b-4f09-40a0-a75f-d23d9c6fc0b9 |
Adverse event summaries are temporarily unavailable. Other product information remains available.