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: Pfizer, Madison, NJ 07940 USA
Otc - Purpose
Active ingredients (in each liquid-filled capsule)PurposesAcetaminophen, USP 325 mgPain reliever/Fever reducerDextromethorphan HBr, USP 15 mgCough suppressantDoxylamine Succinate, USP 6.25 mgAntihistamine
Indications & Usage
- Usestemporarily relieves these symptoms occurring with a cold or flu, hay fever, or other upper respiratory allergies:headachesore throatcoughminor aches and painsrunny nosesneezingitchy, watery eyesitching of the nose or throattemporarily reduces fever
- This product contains acetaminophen. Severe liver damage may occur if you takemore than 8 capsules in any 24-hour period, which is the maximum daily amountwith other drugs containing acetaminophen3 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 sleepyif 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.
Ask A Doctor Before Use If You Have
- Liver diseaseglaucomatrouble urinating due to an enlarged prostate glandcough 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 You Are
- Taking the blood thinning drug warfarintaking any other pain reliever/fever reducertaking sedatives or tranquilizers
When Using This Product
- Marked drowsiness may occuravoid 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
- Pain or cough gets worse or lasts more than 7 daysfever gets worse or lasts more than 3 daysredness or swelling is presentcough comes back or occurs with rash or headache that lasts.These could be signs of a serious condition.new symptoms occur
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.
Dosage & Administration
- Directionsdo not take more than 8 capsules in any 24-hour perioddo not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.this adult product is not intended for use in children under 12 years of ageagedoseadults and children 12 years and over2 capsules every 6 hourschildren under 12 yearsdo not use
Storage And Handling
- Other informationstore at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).
Inactive ingredientsD&C yellow no. 10, FD&C blue no. 1, gelatin, glycerin, mineral oil, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution
Otc - Questions
Questions or comments?Call weekdays from 9 AM to 5 PM EST at 1 800-762-4675
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