Indications and uses
temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation sore throat minor aches & pains headache fever
temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation sore throat minor aches & pains headache fever
take only as directed do not exceed 8 softgels per 24 hrs adults & children 12 yrs & over : 2 softgels with water every 4 hrs children 4 to under 12 yrs : ask a doctor children under 4 yrs : do not use
Acetaminophen USP 325 mg
Dextromethorphan HBr USP 10 mg
Pain reliever/Fever reducer
Cough suppressant
temporarily relieves common cold/flu symptoms:
Liver warning:
This product contains acetaminophen.Severe liver damage may occur if you take
Allergy Alert:
Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away
Sore throat warning:
If sore throat is severe, persists for more than 2 days,is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.
● with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
● 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.
These could be signs of a serious condition.
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away.
Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
FD&C blue no. 40, FD&C Yellow no.6, gelatin, glycerin, polyethylene glycol 400, povidone K-30, propylene glycol, purified water, sorbitol sorbitan solution
Store at 20-25 ºC (68-77ºF)
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 35916-2211 | 35916-2211-1 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITAN | 6O92ICV9RU | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| SORBITOL | 506T60A25R | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| GELATIN | 2G86QN327L | IACT |
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 1 | 2026-06-06 | daily-update | 2026-06-11 05:11:05 |
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 |
|---|---|---|---|---|---|---|
| Acetominophen, Dextromethorphan hydrobromide | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Softgel Healthcare Private Limited | 5302bc6d-d947-31c3-e063-6294a90a09f3 | 2026-08-03 | Warnings | 35916-2211-1 35916-2211 35916221101 5821ad21-a279-cbd8-e063-6394a90ada5f 5302bc6d-d947-31c3-e063-6294a90a09f3 |
Adverse event summaries are temporarily unavailable. Other product information remains available.