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)Acetaminophen 500 mgChlorpheniramine Maleate 4 mgPhenylephrine HCl 10 mg
Otc - Purpose
PURPOSEPain Reliever/Fever ReducerAntihistamineNasal decongestant
Indications & Usage
- Uses:temporarily relieves these symptoms of hay fever or other respiratory allergies:headachesinus congestion & pressurenasal congestionrunny nose and sneezingminor aches & paintemporarily relieves these additional symptoms of hay fever:itching of the nose or throatitchy, watery eyeshelps clear nasal passageshelps decongest sinus opening and passages
- WarningsLiver warning: This product contains acetaminophen. Severe liver damage may occur if you take :
- More than 6 tablets in 24 hours, which is the maximum daily amount for this productwith other drugs contains acetaminophen3 or more alcoholic drinks every day while using this product.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.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 doctor promptly
Otc - Do Not Use
- Do not use:with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacistif 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.if you have ever had an allergic reaction to this product or any of its ingredientsto make a child sleepy
Otc - Ask Doctor
- Ask a doctor before use if you have:liver diseaseheart diseasehigh blood pressurethyroid diseaseglaucomadiabetestrouble urinating due to enlarged prostate glanda breathing problem such as emphysema or chronic bronchitis
Otc - Ask Doctor/Pharmacist
- Ask a doctor or pharmacist before use if you are:taking the blood thinning drug warfarintaking sedatives or tranquilizers
Otc - When Using
- When using this product: do not use more than directedexcitability may occur, especially in childrendrowsiness may occuralcohol, sedatives and tranquilizers may increase drowsinessavoid alcoholic drinksbe careful when driving a motor vehicle or operating machinery
Otc - Stop Use
- Stop use and ask a doctor if:nervousness, dizziness, or sleeplessness occurpain or nasal congestion gets worse or lasts more than 7 daysfever gets worse or last more than 3 daysredness or swelling is presentnew symptoms occurThese 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.Overdose warning: Taking more tahn directed can cause serious health problems. 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 take more than directed - see overdose warningSwallow whole; do not crush, chew or dissolveDo not exceed 6 tablets per 24 hoursAdults and children 12 years of age & over1 tablet with water every 4-6 hours as neededChildren 4 to 12 years of ageAsk a doctorChildren under 4 years of ageDo not use
Storage And Handling
- Other information:Store at room temperature between 20-25°C (68-77ºF)Avoid excessive heat and humidity
Inactive ingredients: Microcrystalline cellulose, Polyvinylpyrollidone, Crospovidone, Magnesium Stearate, Colloidal Silicon Dioxide, Purified Talc
Otc - Questions
Questions or comments?Call: (619) 600-5632 (Mon-Fri 9am-5pm EST) or https://www.opmx.us
TAMPER EVIDENT: DO NOT USE IF POUCH IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERINGExclusively distributed by:OPMXSan Diego, CA 92154Phone: 619-600-5632
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