Indications and uses
Temporarily relieves common cold/flu symptoms: nasal congestion cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever
Temporarily relieves common cold/flu symptoms: nasal congestion cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever
take only as directed do not exceed 8 Softgels per 24 hrs adults & children 12 years & over 2 Softgels with water every 4 hours children 4 to under 12 years ask a doctor children under 4 years do not use
Acetaminophen USP 325 mg
Dextromethorphan HBr USP 10 mg
Phenylephrine HCl USP 5 mg
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
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.
taking the blood thinning drug warfarin.
do not use more than directed.
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.
| adults & children 12 years & over | 2 Softgels with water every 4 hours |
| children 4 to under 12 years | ask a doctor |
| children under 4 years | do not use |
D&C yellow no. 10, gelatin, glycerin, polyethylene glycol 400, povidone k 30, propylene glycol, purified water, sorbitol sorbitan solution
label
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68210-5053 | 68210-5053-1 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| SORBITOL | 506T60A25R | IACT |
| WATER | 059QF0KO0R | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 3 | 2026-07-18 | daily-update | 2026-07-21 05:10:12 |
| 2 | 2025-12-31 | full-release | 2026-06-01 01:30:05 |
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 |
|---|---|---|---|---|---|---|
| Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE | Prodose, Inc. | 3afc88c7-388a-dbd9-e063-6294a90a4faf | 2026-07-24 | Warnings | 68210-5053-1 68210-5053 68210505301 575a1070-780c-5032-e063-6294a90a642a 3afc88c7-388a-dbd9-e063-6294a90a4faf |
Adverse event summaries are temporarily unavailable. Other product information remains available.