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
- Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddeningblistersrash
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 sleeplesspain, nasal congestion or cough gets worse or last more than 7 daysfever 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 useIf taking Daytime and Nighttime softgels carefully read each label to insure correct dosing
- Store at room temperature 15°-30°C (59°-86°F) and avoid excessive heatthis product does not contain phenylpropanolamine
FD&C Red No. 40, FD&C Yellow No.6. gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide
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