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.
Distributed By: J.P Business EnterpriseLake Grove, NY 11755
Otc - Purpose
Active ingredients (in each softgel)PurposeAcetaminophen 325 mgPain reliever/fever reducerDextromethorphan Hydrobromide 15 mgCough suppressantDoxylamine Succinate 6.25 mgAntihistamine
- Temporarily relieves common cold/flu symptoms:cough due to minor throat and bronchial irritationsore throatheadacheminor aches/painsfeverrunny nose and sneezing
- 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 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, or occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.
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.to make a child sleep
Ask A Doctor Before Use If You Have
- Liver diseaseglaucomacough that occurs with too much phlegm (mucus)a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysematrouble urinating due to enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
- Taking sedatives or tranquilizerstaking the blood-thinning drug warfarin.
When Using This Product
- Do not use more than directedexcitability may occur especially in childrenmarked drowsiness may occuravoid alcoholic drinksbe careful with driving a motor vehicle or operating machineryalcohol, sedatives and tranquilizers may increase drowsiness
Stop Use And Ask A Doctor If
- Pain or cough gets worse or lasts 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 lasts.These 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 the recommended dose 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 as well as for children, even if you do not notice any signs or symptoms.
- Take only as recommended—see Overdose warning.do not exceed 4 doses per 24 hoursadults and children 12 years of age and overswallow 2 softgels with water every 6 hourschildren 4 to under 12 years of ageask a doctorchildren under 4 years of agedo not useIf taking Nighttime and Daytime 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
D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide
* Please review the disclaimer below.