Indications and uses
• temporarily relieves these symptoms due to a cold or flu: • minor aches and pains • headache • cough •sore throat • nasal and sinus congestion •temporarily reduces fever
• temporarily relieves these symptoms due to a cold or flu: • minor aches and pains • headache • cough •sore throat • nasal and sinus congestion •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 10 capsules in 24 hours or as directed by a doctor. children under 12 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 these symptoms due to a cold or flu:
• minor aches and pains • headache • cough
•sore throat • nasal and sinus congestion
•temporarily reduces fever
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
• more than 4,000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:
• skin reddening • blisters • rash • hives
• facial swelling • asthma (wheezing) • shock
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.
● 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.
● if you have ever had an allergic reaction to this product or any of its ingredients
● in children under 12 years of age
● liver disease ● heart disease ● high blood pressure
● thyroid disease ● diabetes
● cough with excessive phlegm (mucus)
● difficulty in urination due to enlargement of the prostate gland
● persistent or chronic cough such as occurs with smoking, asthma, or emphysema
taking the blood thinning drug warfarin
When using this product do not exceed recommended dosage
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.
● store at room temperature. Avoid excessive heat above 40ºC (104ºF).
FD&C yellow no.5, FD&C yellow no.6, gelatin, glycerin, mica, polyethylene glycol 400, povidone K 30, purified water, sorbitol sorbitan solution, titanium dioxide
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1086997 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 5 |
| 1086997 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 5 |
| 1086997 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SY | 5 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN 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 |
|---|---|---|---|---|---|---|
| 35916-0188-1 | Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg | 1000 in 1 BAG | CAPSULE, LIQUID FILLED | 1000 | 5 | |
| 35916-0188-2 | Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg | 3000 in 1 POUCH | CAPSULE, LIQUID FILLED | 3000 | 5 | |
| 35916-0188-2 | Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg | 2 in 1 BOX | CAPSULE, LIQUID FILLED | 2 | 5 | |
| 35916-0188-3 | Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg | 2000 in 1 POUCH | CAPSULE, LIQUID FILLED | 2000 | 5 | |
| 35916-0188-3 | Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg | 2 in 1 BOX | CAPSULE, LIQUID FILLED | 2 | 5 | |
| 35916-0188-4 | Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg | 2 in 1 BOX | CAPSULE, LIQUID FILLED | 2 | 5 | |
| 35916-0188-4 | Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg | 1500 in 1 BAG | CAPSULE, LIQUID FILLED | 1500 | 5 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 35916-0188 | 35916-0188-1, 35916-0188-2, 35916-0188-3, 35916-0188-4 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITAN | 6O92ICV9RU | IACT |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| MICA | V8A1AW0880 | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| SORBITOL | 506T60A25R | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| GELATIN | 2G86QN327L | IACT |
| FD&C YELLOW NO. 5 | I753WB2F1M | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 4 | 2026-01-16 | monthly-update | 2026-06-03 17:52:58 |
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 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg | ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL | Softgel Healthcare Private Limited | 30ab39f3-27cc-5728-e063-6394a90a9cbe | 2026-04-27 | Warnings | 35916-0188-2 35916-0188-4 35916-0188-3 35916-0188-1 35916-0188 35916018802 35916018804 35916018801 35916018803 5003542f-a0ff-cd67-e063-6294a90aee97 30ab39f3-27cc-5728-e063-6394a90a9cbe |
Adverse event summaries are temporarily unavailable. Other product information remains available.