The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Product Labeling Index
Active Ingredients (In Each Softgel)
Acetaminophen 325 mgDextromethorphan HBr 10 mgPhenylephrine HCl 5 mg
Pain reliever/fever reducerCough suppressantNasal decongestant
- Temporarily relieves common cold/flu symptoms:nasal congestioncough due to minor throat & bronchial irritationsore throatheadacheminor aches & painsfever
- Liver warningThis product contains acetaminophen. Severe liver damage may occur if you takemore than 4 doses in 24 hrs, which is the maximum daily amount for this productwith other drugs containing acetaminophen3 or more alcoholic drinks daily while using this productSore throat warningIf sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:skin reddeningblistersrashIf a skin reaction occurs, stop use and seek medical help right away.
Do Not Use
- 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.
Ask A Doctor Before Use If You Have
- Liver diseaseheart diseasethyroid diseasediabeteshigh blood pressuretrouble urinating due to an enlarged prostate glandcough that occurs with excessive phlegm (mucus)persistent or chronic cough as occurs with smoking, asthma, or emphysema
Stop Use And Ask A Doctor If
- You get nervous, dizzy or sleeplesssymptoms get worse or last more than 5 days (children) or 7 days (adults)fever gets worse or lasts more than 3 daysredness or swelling is presentnew symptoms occurcough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition.
Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.
- Take only as directed - see Overdose warningdo not exceed 4 doses per 24 hrs adults & children 12 yrs & over 2 softgels with water every 4 hrschildren 4 to under 12 yrs ask a doctorchildren under 4 yrs do not usewhen using other Daytime or Nighttime products, carefully read each label to insure correct dosing
- Store at room temperature 15°-30°C (59°-86°F)
FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, white edible ink
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