Infants' TYLENOL® COLD Decongestant & Fever Reducer Concentrated Drops PLUS COUGH are alcohol-free, aspirin-free, Wild Cherry-flavored and red in color. Each 1.6 mL (2 dropperfuls) contains acetaminophen 160 mg, dextromethorphan HBr 5 mg, and pseudoephedrine HCl 15 mg.
Acetaminophen is a clinically proven analgesic/antipyretic. Acetaminophen produces analgesia by elevation of the pain threshold and antipyresis through action on the hypothalamic heat regulating center. Acetaminophen is equal to aspirin in analgesic and antipyretic effectiveness and it is unlikely to produce many of the side effects associated with aspirin and aspirin-containing products. Pseudoephedrine hydrochloride is a sympathomimetic amine which provides temporary relief of nasal congestion. Dextromethorphan hydrobromide is a cough suppressant which helps relieve coughs.
For the reduction of fever. For the temporary relief of these cold symptoms: coughs, nasal congestion, minor aches and pains, sore throat, headaches.
Infants' Tylenol® Cold Decongestant and Fever Reducer Drops are more concentrated than Children's Tylenol® Cold Liquid Products. For accurate dosing, follow the dosing instructions on the label. If possible, use weight to dose; otherwise use age. All dosages may be repeated every 4-6 hours, if needed. Do not use more than 4 times in 24 hours. Under 2 years (under 24 lbs), consult a physician. A calibrated dropper is provided for accurate dosing. Attention: This product has been specially designed for use only with the enclosed dropper. Do not use any other dosing device with this product.
Infants' TYLENOL® COLD Decongestant & Fever Reducer Concentrated Drops PLUS COUGH: 2-3 years (24-35 lbs) 2 dropperfuls (2 x 0.8 mL).
Professional Dosage Schedule: If possible, use weight to dose; otherwise use age. 0-3 months (6-11 lbs): 1 / 2 dropperful (0.4 mL); 4-11 months (12-17 lbs): 1 dropperful (0.8 mL); 12-23 months (18-23 lbs): 1 1 / 2 dropperfuls (1.2 mL). All dosages may be repeated every 4-6 hours, if needed. Do not use more than 4 times in 24 hours.
If a rare sensitivity reaction occurs, the drug should be discontinued.
Do not use if plastic carton wrap or bottle wrap imprinted "Safety Seal®" is broken or missing. Do not take for pain for more than 5 days or for fever for more than 3 days unless directed by a doctor. If pain or fever persists, or gets worse, if new symptoms occur, or if redness or swelling is present, consult a doctor because these could be signs of a serious condition. 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. If nervousness, dizziness or sleeplessness occur, discontinue use and consult a doctor. Do not give this product to children who have heart disease, high blood pressure, thyroid disease, or diabetes without first consulting the child's doctor. A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur or is accompanied by fever, rash or persistent headache, consult a doctor. Do not give this product for persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. Do not exceed recommended dosage. Taking more than the recommended dose (overdose) may not provide more relief and could cause serious health problems. Keep this and all drugs out of the reach of children. In case of accidental overdose, contact a doctor or poison control center immediately. Prompt medical attention is critical even if you do not notice any signs or symptoms. Do not use with other products containing acetaminophen.
Do not give this product to a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions), or for 2 weeks after stopping the MAOI drug. If you are uncertain whether your child's prescription drug contains an MAOI, consult a health professional before giving this product.
Acetaminophen in massive overdosage may cause hepatic toxicity in some patients. In adults and adolescents (>/= 12 years of age), hepatic toxicity may occur following ingestion of greater than 7.5 to 10 grams over a period of 8 hours or less. Fatalities are infrequent (less than 3-4% of untreated cases) and have rarely been reported with overdoses of less than 15 grams. In children (< 12 years of age), an acute overdosage of less than 150 mg/kg has not been associated with hepatic toxicity.
Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours postingestion. In adults and adolescents, any individual presenting with an unknown amount of acetaminophen ingested or with a questionable or unreliable history about the time of ingestion should have a plasma acetaminophen level drawn and be treated with N -acetylcysteine. For full prescribing information, refer to the N -acetylcysteine package insert. Do not await results of assays for plasma acetaminophen levels before initiating treatment with N -acetylcysteine. The following additional procedures are recommended: Promptly initiate gastric decontamination of the stomach. A plasma acetaminophen assay should be obtained as early as possible, but no sooner than four hours following ingestion. If an acetaminophen extended release product is involved, it may be appropriate to obtain an additional plasma acetaminophen level 4-6 hours following the initial acetaminophen level. If either acetaminophen level plots above the treatment line on the acetaminophen overdose nomogram, N -acetylcycsteine treatment should be continued for a full course of therapy. Liver function studies should be obtained initially and repeated at 24-hour intervals.
Serious toxicity or fatalities have been extremely infrequent following an acute acetaminophen overdose in young children, possibly because of differences in the way they metabolize acetaminophen. In children, the maximum potential amount ingested can be more easily estimated. If more than 150 mg/kg or an unknown amount was ingested, obtain a plasma acetaminophen level as soon as possible, but no sooner than 4 hours following ingestion. If an acetaminophen extended release product is involved, it may be appropriate to obtain an additional plasma acetaminophen level 4-6 hours following the initial acetaminophen level. If either acetaminophen level plots above the treatment line on the acetaminpohen overdose nomogram, N -acetylcysteine treatment should be initiated and continued for a full course of therapy. If an assay cannot be obtained and the estimated acetaminophen ingestion exceeds 150 mg/kg, dosing with N -acetylcysteine should be initiated and continued for a full course of therapy.
For additional emergency information, call your regional poison center or call the Rocky Mountain Poison Center toll-free, (1-800-525-6115).
Symptoms from pseudoephedrine overdose consist most often of mild anxiety, tachycardia and/or mild hypertension. Symptoms usually appear within 4 to 8 hours of ingestion and are transient, usually requiring no treatment.
Acute dextromethorphan overdose usually does not result in serious signs and symptoms unless massive amounts have been ingested. Signs and symptoms of a substantial overdose may include nausea and vomiting, visual disturbances, CNS disturbances and urinary retention.
Acesulfame Potassium, Citric Acid, Corn Syrup, FD&C Red #40, Flavors, Polyethylene Glycol, Propylene Glycol, Sodium Benzoate.
Red-colored drops in bottles of ½ fl. oz. Store at room temperature.
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