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 ingredient (in each packet)Acetaminophen, 650 mgPheniramine maleate, 20 mgPhenylephrine HCl, 10 mg
Otc - Purpose
PurposesPain reliever / fever reducerAntihistamineNasal decongestant
Indications & Usage
Uses• temporarily relieves these symptoms due to a cold:• minor aches and pains • minor sore throat pain • headache • nasal and sinus congestion • runny nose • sneezing • itchy nose or throat • itchy, watery eyes due to hay fever • temporarily reduces fever
WarningsLiver 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 reactions. Symptoms may include:• skin reddening • blisters • rashIf a skin 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.
Otc - Ask Doctor
Ask a doctor before use if you have• liver disease • heart disease • high blood pressure • thyroid disease • diabetes • glaucoma • trouble urinating due to an enlarged prostate gland • a breathing problem such as emphysema, or chronic bronchitis • a sodium-restricted dietAsk a doctor or pharmacist before use if you are• taking sedatives or tranquilizers • taking the blood thinning drug warfarinWhen using this product• do not exceed recommended dosage•avoid alcoholic drinks•may cause drowsiness• alcohol, sedatives, and tranquilizers may increase drowsiness• be careful when driving a motor vehicle or operating machinery• excitability may occur, especially in childrenStop use and ask a doctor if• nervousness, dizziness, or sleeplessness occurs • pain or nasal congestion gets worse or lasts more than 7 days • fever gets worse or lasts more than 3 days • new symptoms occur • redness or swelling is present. These could be signs of a serious condition.If pregnant or breast-feeding,ask a health care professional before use.
Otc - Do Not Use
Do not use• in a child under 12 years of age • if you are allergic to acetaminophen• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a 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.
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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Dosage & Administration
Directions• do not use more than directed• take every 4 hours, while symptoms persist. Do not take more than 5 packets in 24 hours unless directed by a doctorAGEDOSEAdults and children 12 years of age and overOne packetChildren under 12 years of ageDo not use• dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10 - 15 minutes.• if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat.
Other Safety Information
Other information■each packet contains: Sodium 9.37 mg■ Protect from heat and moisture.■ Do not use if printed packet is torn or punctured.■ Store between 68-77°F (20-25°C)
Inactive ingredientsCalcium phosphate, Citric acid, Lemon flavour, Malic acid, Sodium citrate, Sucrose, Titanium dioxide
Otc - Questions
Questions?Call 1-888-(OK-HERBION) 654-3724, Monday through Friday, 9am - 5pm EST
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