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.
Active Ingredients (In Each 20 Ml)
Acetaminophen, USP 650 mgDiphenhydramine HCl, USP 25 mgPhenylephrine HCl, USP 10 mg
Pain reliever/Fever reducerAntihistamine/CoughsuppressantNasal decongestant
- •temporarily relieves these symptoms occurring with a cold or flu, hay fever, or other respiratory allergies: •cough due to minor throat and bronchial irritation •nasal congestion •headache •sore throat •minor aches and pains •runny nose •sneezing •itchy, watery eyes •itching of the nose and throat •temporarily reduces fever
- This product contains acetaminophen. Severe liver damage may occur if you take •more than 6 doses in any 24-hour period, which is the maximum daily amount •with other drugs containing acetaminophen •3 or more alcoholic drinks every day while using this productAllergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: •skin reddening •blisters •rashIf 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 a doctor promptly.
Otc - Do Not Use
- Do not use •to sedate a child or to make a child sleepy •if 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 You Have
- •liver disease •heart disease •high blood pressure •thyroid disease •diabetes •trouble urinating due to an enlarged prostate gland •glaucoma •a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema •cough that occurs with too much phlegm (mucus)
Ask A Doctor Or Pharmacist Before Use If You Are
- •taking the blood thinning drug warfarin •taking any other oral nasal decongestant or stimulant •taking any other pain reliever/fever reducer •taking sedatives or tranquilizers
When Using This Product
- •do not use more than directed •marked drowsiness may occur •avoid alcoholic drinks •alcohol, sedatives, and tranquilizers may increase drowsiness •be careful when driving a motor vehicle or operating machinery •excitability may occur, especially in children
Stop Use And Ask A Doctor If
- •you get nervous, dizzy, or sleepless •pain, cough, or nasal congestion gets worse or lasts more than 7 days •fever gets worse or lasts more than 3 days •redness or swelling is present •new symptoms occur •cough comes back or occurs with 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 take more than 6 doses in any 24-hour period •do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage. •measure only with dosing cup provided •keep dosing cup with product •ml = milliliter •this adult product is not intended for use in children under 12 years of ageagedoseadults and children 12 years and over20 ml every 4 hourschildren under 12 yearsdo not use
Storage And Handling
- Other information •each 20 ml contains: sodium 15 mg •store 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
Distributed by: Pfizer, Madison, NJ 07940 USA
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