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.
Otc - Purpose
Active ingredients (in each softgel)PurposeAcetaminophen 325 mgPain reliever/fever reducerDextromethorphan Hydrobromide 10 mgCough suppressantPhenylephrine HCl 5 mgNasal decongestant
- Temporarily relieves common cold/flu symptoms:nasal congestioncough due to minor throat & bronchial irritationsore throatheadacheminor aches/painsfever
- 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 productwith other drugs containing acetaminophen3 or more alcoholic drinks every day while using this product
Sore Throat Warning
If 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.
Otc - Do Not Use
- 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 enlarged prostate glandcough that occurs with too much phlegm (mucus)persistent or chronic cough as occurs with smoking, asthma, or emphysema
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking the blood-thinning drug Warfarin.
When Using This Product
- Do not use more than directed.
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 lastsThese could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
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 and for children, even if you do not notice any signs or symptoms.
- Take only as directed—see
- Overdose warning.
- Do not exceed 4 doses per 24 hours.adults and children 12 years of age and overswallow 2 softgels with water every 4 hourschildren 4 to under 12 years of ageask a doctorchildren under 4 years of agedo not useWhen using other Daytime or Nighttime products, carefully read each label to ensure correct dosing
- Store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
FD&C Red# 40, FD&C Yellow# 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide
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