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 - Active Ingredient
Active ingredients (in each tablet) PurposesAcetaminophen 325 mg…………….………...Pain reliever/fever reducerChlorpheniramine maleate 2 mg……………………..……..AntihistamineDextromethorphan hydrobromide 10 mg……………Cough suppressantPhenylephrine hydrochloride 5 mg………………….Nasal decongestant
- Temporarily relieves these symptoms due to a cold or flu:minor aches and painsheadachecoughsore throatrunny nosesneezingnasal congestion · sinustemporarily reduces fever
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
· more than 4,000 mg of acetaminophen in 24 hours· with other drugs containing acetaminophen· 3 or more alcoholic drinks every day while using this productAllergy alert: Acetaminophen may cause severe skin or severe
allergic reactions. Symptoms may include:· skin reddening · blisters · rash · hives · facial swelling · asthma (wheezing) · shock If a skin or general allergic reaction occurs, stop use 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.Do not use to sedate children.
Otc - Do Not Use
- Do not usewith 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 emotionalconditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drugcontains an MAOI, ask a doctor or pharmacist before taking this productif you have ever had an allergic reaction to this product or any of its ingredientsin children under 12 years of age
Otc - Ask Doctor/Pharmacist
- Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarintaking sedatives or tranquilizers
Otc - When Using
- When using this productdo not exceed recommended dosagemay cause marked drowsinessavoid alcoholic drinksalcohol, sedatives, and tranquilizers may increase drowsinessbe careful when driving a motor vehicle or operating machineryexcitability may occur, especially in children
Otc - Stop Use
- Stop use and ask a doctor ifpain, cough, or nasal congestion 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. Thesecould be signs of a serious condition.nervousness, dizziness, or sleeplessness occurs
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. 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.
Dosage & Administration
- Directionsdo not take more than the recommended doseadults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 10 tablets in 24 hours or as directed by a doctor.children under 12 years: do not use
Other Safety Information
Other informationeach tablet contains: potassium 78 mg; sodium 356 mg
store at room temperature. Avoid excessive heat.
Inactive ingredients anhydrous citric acid, calcium silicate, dimethicone, flavors, magnesium stearate, maltodextrin, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose
Otc - Questions
Questions or comments? 1-800-986-0369 (Mon-Fri 9AM - 5PM EST)
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