do not take more than 8 capsules 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. (1-800-222-1222)
| 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 solution, titanium dioxide
1-844-384-3723
Safrel Dextromethorphan Softgels 15 mg - 100 ct
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 71309-601-10 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-892f-d83d-e063-dadaa90ab31f | Safrel Cough Relief Dextromethorphan HBr 15 mg |
| 71309-601-30 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-892f-d83d-e063-dadaa90ab31f | Safrel Cough Relief Dextromethorphan HBr 15 mg |
| 71309-601-60 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-892f-d83d-e063-dadaa90ab31f | Safrel Cough Relief Dextromethorphan HBr 15 mg |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71309-601-10 | Safrel Cough Relief | 100 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 100 | 1 | |
| 71309-601-30 | Safrel Cough Relief | 30 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 30 | 1 | |
| 71309-601-60 | Safrel Cough Relief | 60 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 60 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 71309-601 | 71309-601-30, 71309-601-10, 71309-601-60 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| POVIDONE, UNSPECIFIED | FZ989GH94E | IACT |
| WATER | 059QF0KO0R | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | 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 |
|---|---|---|---|---|---|---|
| f4cc6aa7-fa19-1d62-e053-2995a90a59e8 | f4cc6a9d-c093-4373-e053-2a95a90a1ca6 | 2023-01-01 | Warnings | f4cc6aa7-fa19-1d62-e053-2995a90a59e8 f4cc6a9d-c093-4373-e053-2a95a90a1ca6 |
Adverse event summaries are temporarily unavailable. Other product information remains available.
