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 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 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.
• 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
• pain, cough, or nasal congestion gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
• nervousness, dizziness, or sleeplessness occurs
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.
• 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
• 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
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 35916-0187 | 35916-0187-1 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MICA | V8A1AW0880 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| SORBITOL | 506T60A25R | IACT |
| FD&C YELLOW NO. 5 | I753WB2F1M | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| WATER | 059QF0KO0R | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| POVIDONE K30 | U725QWY32X | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| GELATIN | 2G86QN327L | IACT |
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 |
|---|---|---|---|---|---|---|
| 2faa56ce-2823-713c-e063-6394a90abdc2 | 2ef584ba-018b-793d-e063-6394a90a2af0 | 2025-03-06 | Warnings | 2ef584ba-018b-793d-e063-6394a90a2af0 |
Adverse event summaries are temporarily unavailable. Other product information remains available.