temporarily relieves common cold/flu symptoms: • nasal congestion • sinus congestion & pressure • cough due to minor throat & bronchial irritation • cough to help you sleep • minor aches & pains • headache • fever • sore throat • runny nose & sneezing • reduces swelling of nasal passages • temporarily restores freer breathing through the nose • promotes nasal and/or sinus drainage
•take only as directed • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 2 caplets 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
Phenylephrine HCL 5 Mg
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
temporarily relieves common cold/flu symptoms: • nasal congestion • sinus congestion & pressure • cough due to minor throat & bronchial irritation • cough to help you sleep • minor aches & pains • headache • fever • sore throat • runny nose & sneezing • reduces swelling of nasal passages • temporarily restores freer breathing through the nose • promotes nasal and/or sinus drainage
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
• more than 4 doses in 24 hours, which is the maximum daily amount for this product
•with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product
Allergy Alert: acetaminophen may cause severe skin reactions. Symptoms may include:
• Skin reddening • Blisters • Rash
If a skin reaction occurs, stop ues 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.
• liver disease • heart disease • high blood pressure • thyroid disease • diabetes • glaucoma • cough that occurs with too much phlegm (mucus) • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema • trouble urinating due to enlarged prostate gland
Ask a doctor or pharmacist before ues if you are • taking sedatives or tranquilizers • taking the blood thinning drug warfarin
• do not use more than directed • excitability may occur, especially in children • marked drowsiness may occur • avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery • alcohol, sedatives, and tranquilizers may increase drowsiness
• you get nervous, dizzy or sleepless • pain, nasal congestion, or cough gets worse or lasts more than 7 days • fever gets wore 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.
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.
•take only as directed • do not exceed 4 doses per 24 hrs
| adults & children 12 yrs & over | 2 caplets with water every 4 hrs |
| children 4 to under 12 yrs | ask a doctor |
| children under 4 yrs | do not use |
• store at room temperature
crospovidone, D&C Yellow No.10, FD&C Blue No.1, FD&C Yellow No.6, Magnesium stearate,mica, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide
1-800-362-1683
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 50269-813 | 50269-813-02 |
| 37000-813 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| 33d7d1b8-b372-17d2-e054-00144ff8d46c | 3c4753a1-9663-4203-87aa-e6c1e99fdaf9 | 2016-05-27 | Warnings | 33d7d1b8-b372-17d2-e054-00144ff8d46c 3c4753a1-9663-4203-87aa-e6c1e99fdaf9 |
Adverse event summaries are temporarily unavailable. Other product information remains available.