Description: Infants' TYLENOL® Cold Decongestant & Fever Reducer Concentrated Drops are alcohol-free, aspirin-free, BubbleGum Blast-flavored and red in color. Each 1.6 mL (2 dropperfuls) contains acetaminophen 160 mg and pseudoephedrine HCl 15 mg. 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. Children's TYLENOL® Cold Suspension Liquid is Great Grape-flavored and contains no alcohol or aspirin. Each teaspoonful (5 mL) contains acetaminophen 160 mg, chlorpheniramine maleate 1 mg and pseudoephedrine HCl 15 mg. Children's TYLENOL® Cold Chewable Tablets are Great Grape-flavored and each tablet contains acetaminophen 80 mg, chlorpheniramine maleate 0.5 mg and pseudoephedrine HCl 7.5 mg. Children's TYLENOL® Cold Plus Cough Suspension Liquid is Wild-Cherry-flavored and contains no alcohol or aspirin. Each teaspoonful (5 mL) contains acetaminophen 160 mg, chlorpheniramine maleate 1 mg, dextromethorphan HBr 5 mg and pseudoephedrine HCl 15 mg. Children's TYLENOL® Cold Plus Cough Chewable Tablets are Wild-Cherry-flavored and each tablet contains acetaminophen 80 mg, chlorpheniramine maleate 0.5 mg, dextromethorphan HBr 2.5 mg, and pseudoephedrine HCl 7.5 mg.
Actions: 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.
Chlorpheniramine maleate is an antihistamine that provides temporary relief of runny nose, sneezing and watery and itchy eyes.
Dextromethorphan hydrobromide is a cough suppressant which helps relieve coughs.
Uses: Infants' TYLENOL® Cold Decongestant & Fever Reducer Concentrated Drops: For the reduction of fever. For the temporary relief of these cold symptoms: minor aches and pains, nasal congestion, headaches.
Infants' TYLENOL® Cold Decongestant & Fever Reducer Concentrated Drops Plus Cough: For the reduction of fever. For the temporary relief of these cold symptoms: coughs, nasal congestion, minor aches and pains, sore throat, headaches. Children's TYLENOL® Cold Suspension Liquid and Chewable Tablets: For the temporary relief of these cold symptoms: nasal congestion, runny nose, sore throat, sneezing, minor aches and pains, headaches and fever. Children's TYLENOL® Cold Plus Cough Suspension Liquid and Chewable Tablets: For the temporary relief of these cold symptoms: minor aches and pains, sore throat, coughs, nasal congestion, headaches, fever, sneezing, runny nose.
Directions: See Table 1: Children's Tylenol Dosing Chart on pg. ___
Precautions: If a rare sensitivity reaction occurs, the drug should be discontinued.
Warnings: 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 nervousness, dizziness, or sleeplessness occur, discontinue use and consult 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.
Drug Interaction Precaution: Do not give this product to a child who is taking a prescription monamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions or Parkinson' disease), 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.
Infants' TYLENOL® Cold Decongestant & Fever Reducer Concentrated Drops:
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. Do not use if plastic carton wrap or bottle wrap imprinted "Safety Seal®" is broken or missing.
Infants' TYLENOL® Cold Decongestant & Fever Reducer Concentrated Drops Plus Cough: 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 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 use if plastic carton wrap or bottle wrap imprinted "Safety Seal®" is broken or missing.
Children's TYLENOL® Cold Suspension Liquid and Chewable Tablets: 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. May cause excitability especially in children. Do not give this product to children who have a breathing problem such as chronic bronchitis, or who have glaucoma, heart disease, high blood pressure, thyroid disease, or diabetes without first consulting the child's doctor. May cause drowsiness. Sedatives and tranquilizers may increase the drowsiness effect. Do not give this product to children who are taking sedatives or tranquilizers, without first consulting the child's doctor. Suspension Liquid: Do not use if plastic carton wrap, bottle wrap, or foil inner seal imprinted "Safety Seal®" is broken or missing. Chewable Tablets: Do not use if carton is opened or if blister unit is broken. Phenylketonurics: contains phenylalanine 6 mg per tablet.
Children's TYLENOL ® Cold Plus Cough Suspension Liquid and Chewable Tablets: 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. May cause excitability especially in children. Do not give this product to children who have a breathing problem such as chronic bronchitis, or who have glaucoma, heart disease, high blood pressure, thyroid disease, or diabetes without first consulting the child's doctor. May cause drowsiness. Sedatives and tranquilizers may increase the drowsiness effect. Do not give this product to children who are taking sedatives or tranquilizers, 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. Liquid: Do not use if plastic carton wrap, bottle wrap, or foil inner seal imprinted "Safety Seal®" is broken or missing. Tablets: Do not use if carton is opened or if blister unit is broken. Phenylketonurics: contains phenylalanine 4 mg per tablet.
For overdosage information, please refer to pgs. ___-___
Infants' TYLENOL® Cold Decongestant & Fever Reducer Concentrated Drops: Citric Acid, Corn Syrup, FD&C Red #40, Flavors, Polyethylene Glycol, Propylene Glycol, Saccharin, Sodium Benzoate.
Infants' TYLENOL® Cold Decongestant & Fever Reducer Concentrated Drops Plus Cough: Acesulfame Potassium, Citric Acid, Corn Syrup, FD&C Red #40, Flavors, Polyethylene Glycol, Propylene Glycol, Sodium Benzoate.
Children's TYLENOL® Cold: Suspension Liquid: acesulfame potassium, butylparaben, cellulose, citric acid, corn syrup, D&C Red #33, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium carboxymethylcellulose, sorbitol, xanthan gum. Chewable Tablets: Aspartame, Basic Polymethacrylate, Cellulose, Cellulose Acetate, Citric Acid, D&C Red #7, FD&C Blue #1, Flavors, Hydroxypropyl Methylcellulose, Magnesium Stearate, Mannitol.
Children's TYLENOL® Cold Plus Cough: Suspension Liquid: Acesulfame K, Butylparaben, Cellulose, Citric Acid, Corn Syrup, D&C Red #33, FD&C Red #40, Flavors, Glycerin, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Carboxymethylcellulose, Sorbitol, Xanthan Gum: Chewable Tablets: Aspartame, Basic Polymethacrylate, Cellulose, Cellulose Acetate, D&C Red #7, Flavors, Hydroxypropyl Methylcellulose, Magnesium Stearate, Mannitol.
How Supplied: Infants' TYLENOL® Cold Decongestant & Fever Reducer Concentrated Drops, Infants' TYLENOL® Cold Decongestant & Fever Reducer Concentrated Drops Plus Cough: Red-colored drops in bottles of 1 / 2 fl. oz. Store at room temperature.
Children's TYLENOL® Cold: Suspension Liquid: Purple-colored-bottles of 4 fl. oz. Store at room temperature. Chewable Tablets: Purple-colored, imprinted "TYLENOL COLD" on one side and "TC" on opposite side- blisters of 24. Store at room temperature.
Children's TYLENOL® Cold Plus Cough: Suspension Liquid: Red-colored suspension-bottles of 4 fl. oz. Store at room temperature.
Chewable Tablets: Red-colored, imprinted TYLENOL C/C" on one side and "TC/C" on the opposite side- blisters of 24. Store at room temperature.
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