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.
Distributed by:Pfizer, Madison, NJ 07940 USA
Otc - Purpose
Active ingredients (in each 10 ml)PurposesAcetaminophen, USP 320 mgPain reliever/Fever reducerDiphenhydramine HCl, USP 12.5 mgAntihistamine/Cough suppressantPhenylephrine HCl, USP 5 mgNasal decongestant
Indications & Usage
- Usestemporarily relieves these symptoms associated with a cold, or flu: headachesore throatfeverminor aches and painstemporarily relieves nasal congestion, and cough due to minor throat and bronchial irritation occurring with a coldtemporarily relieves these symptoms due to hay fever or other upper respiratory allergies:sneezingitching of the nose or throatitchy, watery eyesrunny nosetemporarily restores freer breathing through the nose
- This product contains acetaminophen. Severe liver damage may occur if user takesmore than 5 doses 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 sleepyin a child under 6 years of ageif user is 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 any other pain reliever/fever reducertaking sedatives or tranquilizers
When Using This Product
- Do not use more than directedmarked 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
- User gets nervous, dizzy, or sleeplesspain, 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 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 5 doses in any 24-hour perioddo 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 hourschildren 6 to 12 years 10 ml every 4 hourschildren under 6 years do not use
Storage And Handling
- Other informationeach 10 ml contains: sodium 7 mgstore at 20-25°C (68-77°F)
Inactive ingredientsanhydrous 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
Otc - Questions
Questions or comments?Call weekdays from 9 AM to 5 PM EST at 1-800-762-4675For most recent product information, visit www.dimetapp.com
* Please review the disclaimer below.