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.
Product Labeling Index
Active Ingredients (in each packet) PurposeAcetaminophen 650 mg.........................................Pain reliever/Fever reducerDiphenhydramine Hydrochloride 25 mg.............Antihistamine/Cough SuppressantPhenylephrine Hydrochloride 10 mg......................................Nasal decongestant
- Temporarily relieves these symptoms due to cold:minor aches and pains headacheminor sore throat painnasal and sinus congestioncough due to minor throat and bronchial irritationrunny nosesneezingitchy, watery eyes due to hay feveritchy nose or throatTemporarily reduces fever
- Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:more than 6 packets in 24 hours, which is the maximum daily amountwith other drugs containing acetaminophen3 or more alcoholic drinks every day while using this product.Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may includeskin reddeningblistersrashIf 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.
Do Not Use
- In a child under 12 years of ageif you are allergic to acetaminophenwith any other drug containing acetaminophen (prescription and non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on the skin 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 a MAOI, ask a doctor or pharmacist before taking this product.
When Using This Product
- Do not exceed recommended dosageavoid alcoholic drinksmarked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsinessbe careful when driving a motor vehicle or operating machineryexcitability may occur, especially in children.
Stop Use And Ask A Doctor If
- Nervousness, dizziness, or sleeplessness occurs fever gets worse or lasts more than 3 daysredness or swelling is presentnew symptoms occurpain, cough or nasal congestion gets worse or lasts more than 7 dayscough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
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.
- Do not use more than directedtake every 4 hours, while symptoms persist.Do not take more than 6 packets in 24 hours unless directed by a doctor.AgeDoseadults and children 12 years and overone packetchildren under 12 yearsdo not usedissolve 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.
Information For Patients
- Other Informationeach packet contains: potassium 10 mg, sodium 23 mg.phenylketonurics: contains phenylalanine 10 mg per packet.store at controlled room temperature 20-25°C (68 -77°F). Protect from heat and moisture.
Acesulfame potassium, aspartame, calcium phosphate dibasic, citric acid, D&C Yellow #10, maltodextrin, flavors, silicon dioxide, sodium citrate dihydrate.
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