Indications and uses
temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation cough to help you sleep minor aches & pains headache fever sore throat runny nose & sneezing
temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation cough to help you sleep minor aches & pains headache fever sore throat runny nose & sneezing
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 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Pain reliever/Fever reducer
Cough suppressant
Antihistamine
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.
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.
| 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 |
D&C yellow no. 10, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol 400, povidone K-30, propylene glycol, purified water, sorbitol sorbitan solution
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1426334 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | 5 |
| 1426334 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | 5 |
| 1426334 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | 5 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| DOXYLAMINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 35916-0185-2 | Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate | 3000 in 1 POUCH | CAPSULE, LIQUID FILLED | 3000 | 5 | |
| 35916-0185-3 | Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate | 2000 in 1 POUCH | CAPSULE, LIQUID FILLED | 2000 | 5 | |
| 35916-0185-3 | Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate | 2 in 1 BOX | CAPSULE, LIQUID FILLED | 2 | 5 | |
| 35916-0185-4 | Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate | 2 in 1 BOX | CAPSULE, LIQUID FILLED | 2 | 5 | |
| 35916-0185-4 | Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate | 1500 in 1 BAG | CAPSULE, LIQUID FILLED | 1500 | 5 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 35916-0185 | 35916-0185-2, 35916-0185-3, 35916-0185-4 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SORBITOL | 506T60A25R | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| WATER | 059QF0KO0R | IACT |
| GELATIN | 2G86QN327L | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DOXYLAMINE SUCCINATE | V9BI9B5YI2 | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 4 | 2026-01-16 | monthly-update | 2026-06-03 17:52:46 |
| 3 | 2025-12-12 | monthly-update | 2026-06-03 17:45:50 |
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 HBr and Doxylamine Succinate | ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE | Softgel Healthcare Private Limited | 353f71f7-81e0-08c2-e063-6294a90acb49 | 2026-04-27 | Warnings | 35916-0185-2 35916-0185-4 35916-0185-3 35916-0185 35916018502 35916018503 35916018504 50036e03-a441-a430-e063-6394a90a72c7 353f71f7-81e0-08c2-e063-6294a90acb49 |
Adverse event summaries are temporarily unavailable. Other product information remains available.