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.
- Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:skin reddeningblistersrashIf a skin reaction occurs, stop use and seek medical help right away.
Distributed by:Foundation Consumer Brands, LLCPittsburgh, PA 15212
Otc - Purpose
Active ingredients (in each 10 mL)PurposesAcetaminophen, 320 mgPain reliever/fever reducerDiphenhydramine HCl, 12.5 mgAntihistamine/cough suppressantPhenylephrine HCl, 5 mgNasal decongestant
- Temporarily relieves these common cold and flu symptoms:minor aches and painsheadachenasal congestionsore throatcoughrunny noseitching of the nose or throatsneezingtemporarily reduces fevertemporarily restores freer breathing through the nose
- This product contains acetaminophen. Severe liver damage may occur ifadult takes more than 6 doses in 24 hours, which is the maximum daily amountchild takes more than 5 doses in 24 hourstaken with other drugs containing acetaminophenadult has 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.
Do Not Use
- To sedate a child or to make a child sleepyin a child under 6 years of ageif 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.with any other drug containing acetaminophen (prescription or nonprescription). 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 skin
Ask A Doctor Before Use If User Has
- Liver diseaseheart diseasehigh blood pressurethyroid diseasediabetestrouble urinating due to an enlarged prostate glandglaucomacough that occurs with too much phlegm (mucus)a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask A Doctor Or Pharmacist Before Use If User Is
- Taking the blood thinning drug warfarintaking any other oral nasal decongestant or stimulanttaking sedatives or tranquilizers
When Using This Product
- Do not use more than directedmay 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
Stop Use And Ask A Doctor If
- Nervousness, dizziness or sleeplessness occurspain, cough, or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults)fever gets worse or lasts more than 3 daysredness or swelling is presentnew symptoms occurcough 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 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.
- Do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.measure only with dosage cup providedkeep dosage cup with productmL = milliliteragedoseadults and children 12 years and over20 mL every 4 hours do not take more than 6 doses in any 24-hour periodchildren 6 to 12 years10 mL every 4 hours do not give more than 5 doses in any 24-hour periodchildren under 6 yearsdo not use
- Each 10 mL contains: sodium 7 mg and potassium 6 mgstore at 20-25°C (68-77°F)read and keep carton
Anhydrous citric acid, artificial flavor, edetate disodium, FD&C red no. 40, glycerin, menthol, polyethylene glycol, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose
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