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 packet) PurposeAcetaminophen 650 mg ........................................Pain reliever/Fever reducerDiphenhydramine hydrochloride 25 mg .........Anitihistamine/Cough suppressantPhenylephrine hydrochloride 10 mg...................................Nasal decongestant.
Otc - Purpose
Uses- temporarily relieves: - minor aches and pains - headache - minor sore throat pain - nasal and sinus congestion - cough due to minor throat and bronchial irritation - runny nose - sneezing - itchy, watery eyes due to hay fever - itchy nose and throat- temporarily reduces fever.
WarningsLiver 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 amount - with other drugs containing acetaminophen - 3 or more alcoholic drinks every day while using this product.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 - Do Not Use
Do not use- with any other drug containing acetaminophen (prescription and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.- with any other product containing diphenhydramine, even one used on the skin- If you are now taking a prescription monoamine oxidase (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.
Otc - Ask Doctor
Ask a doctor before use if you have- liver
disease - heart disease - high blood pressure - thyroid disease
- glaucoma - diabetes - trouble urinating due to an enlarged
prostate gland - a breathing problem such as emphysema, asthma, or
chronic bronchitis - cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma or
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are- taking sedatives or tranquilizers- taking the blood thinning drug warfarin.
Indications & Usage
When using this product- do not exceed recommended dosage- avoid alcoholic drinks- marked drowsiness may occur- alcohol, sedatives and tranquilizers may increase drowsiness- be careful when driving a motor vehicle or operating machinery- excitability may occur, especially in children.
Otc - Stop Use
Stop use and ask a doctor if- nervousness, dizziness, or sleeplessness occurs- fever gets worse or lasts more than 3 days- redness or swelling is present- new symptoms occur- symptoms do not get better or worsen- pain, cough or nasal congestion gets worse or lasts more than 7 days- cough comes back or occurs with fever, 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 care 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. 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; not to exceed 6 packets in 24 hours or as directed by a doctor.- adults and children 12 years of age and over: dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.- children under 12 years of age: consult a doctor.- 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 information- each packet contains: potassium 7 mg, sodium 46 mg- phenylketonurics: contains phenylalanine 13 mg per packet- store at controlled room temperature 20-25C (68-77F). Protect from excessive heat and moisture.
Acesulfame K, Aspartame, Caramel Color, Citric Acid, D and C Yellow 10, Maltodextrin, Natural Flavors, Sodium Citrate, Starch and Sugar.
* Please review the disclaimer below.