Indications and uses
temporarily relieves these symptoms due to cold/flu: minor aches and pains headache nasal and sinus congestion cough sore throat runny nose sneezing temporarily reduces fever
temporarily relieves these symptoms due to cold/flu: minor aches and pains headache nasal and sinus congestion cough sore throat runny nose sneezing temporarily reduces fever
do not take more than the recommended dose adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 4 capsules in 12 hours or as directed by a doctor. children under 12 years: do not use
Acetaminophen USP 325 mg
Dextromethorphan Hydrobromide USP 10 mg
Doxylamine Succinate USP 6.25 mg
Phenylephrine Hydrochloride USP 5 mg
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
temporarily relieves these symptoms due to cold/flu:
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 or general allergic 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.
Do not use to sedate children.
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 or contact a Poison control center right away. Quick medical medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
directed by a doctor.
Store at 15ºC- 25ºC (59º-77ºF)
candurin silver sheen, candurin silver sparkle, D&C yellow no.10, FD&C blue no.1, gelatin, glycerin, polyethylene glycol 400, povidone K 30, purified water, sorbitol sorbitan solution
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1297288 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 4 |
| 1297288 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 4 |
| 1297288 | APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule | SY | 4 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| DOXYLAMINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 35916-0186-1 | Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride | 3000 in 1 POUCH | CAPSULE, LIQUID FILLED | 3000 | 4 | |
| 35916-0186-1 | Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride | 2 in 1 BOX | CAPSULE, LIQUID FILLED | 2 | 4 | |
| 35916-0186-2 | Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride | 2000 in 1 POUCH | CAPSULE, LIQUID FILLED | 2000 | 4 | |
| 35916-0186-2 | Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride | 2 in 1 BOX | CAPSULE, LIQUID FILLED | 2 | 4 | |
| 35916-0186-3 | Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride | 1500 in 1 BAG | CAPSULE, LIQUID FILLED | 1500 | 4 | |
| 35916-0186-3 | Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride | 2 in 1 BOX | CAPSULE, LIQUID FILLED | 2 | 4 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 35916-0186 | 35916-0186-1, 35916-0186-2, 35916-0186-3 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| MICA | V8A1AW0880 | IACT |
| WATER | 059QF0KO0R | IACT |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| GELATIN | 2G86QN327L | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| SORBITOL | 506T60A25R | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| DOXYLAMINE SUCCINATE | V9BI9B5YI2 | ACTIB |
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 3 | 2026-01-12 | monthly-update | 2026-06-03 17:52:46 |
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, Doxylamine Succinate and Phenylephrine Hydrochloride | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE | Softgel Healthcare Pvt Ltd | 36ced59c-12dc-441f-e063-6294a90a3239 | 2026-04-27 | Warnings | 35916-0186-3 35916-0186-1 35916-0186-2 35916-0186 35916018603 35916018601 35916018602 50034840-bd05-aa85-e063-6394a90ac570 36ced59c-12dc-441f-e063-6294a90a3239 |
Adverse event summaries are temporarily unavailable. Other product information remains available.