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Children's Tylenol Plus Cold & Cough Suspension Liquid and Chewable Tablets, Childrens Tylenol Plus Cold Chewable Tablets, Concentrated Tylenol Infants Drops Plus Cold, Concentrated Tylenol Infants Drops Plus Cold and Cough, Childrens Tylenol Plus Cold N (McNeil Consumer)
DESCRIPTION
Concentrated TYLENOL® Infants' Drops Plus Cold are alcohol-free, aspirin-free, BubbleGum-flavored and red in color. Each 1.6 mL contains acetaminophen 160 mg and pseudoephedrine HCl 15 mg. Concentrated TYLENOL® Infants' Drops Plus Cold & Cough are alcohol-free, aspirin-free, Cherry-flavored and red in color. Each 1.6 mL contains acetaminophen 160 mg, dextromethorphan HBr 5 mg, and pseudoephedrine HCl 15 mg. Children's TYLENOL® Plus Cold Nighttime Suspension Liquid is Grape-flavored and contains no alcohol or aspirin. Each teaspoon (5 mL) contains acetaminophen 160 mg, chlorpheniramine maleate 1 mg and pseudoephedrine HCl 15 mg. Children's TYLENOL® Plus Cold Chewable Tablets are Grape-flavored and each tablet contains acetaminophen 80 mg, chlorpheniramine maleate 0.5 mg and pseudoephedrine HCl 7.5 mg. Children's TYLENOL® Plus Cold & Cough Suspension Liquid is 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® Plus Cold & Cough Chewable Tablets are 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.
Children's TYLENOL® Plus Cold Daytime Non-Drowsy Suspension Liquid is Fruit flavored and contains no alcohol or aspirin. Each teaspoon (5 mL) contains acetaminophen 160 mg and pseudoephedrine HCl 15 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
Concentrated TYLENOL® Infants' Drops Plus Cold: temporarily relieves these cold symptoms:
· minor aches and pains
· nasal congestion · headaches
· temporarily reduces fever
Concentrated TYLENOL® Infants' Drops Plus Cold & Cough: temporarily relieves these cold symptoms:
· coughs · nasal congestion
· minor aches and pains
· sore throat · headaches
· temporarily reduces fever
Children's TYLENOL® Plus Cold Nighttime Suspension Liquid: temporarily relieves these cold symptoms:
· nasal congestion · sore throat · runny nose · sneezing · headache · minor aches and pains
· temporarily reduces fever
Children's TYLENOL® Plus Cold Chewable Tablets: temporarily relieves these cold symptoms:
· nasal congestion · sore throat · runny nose · sneezing · headache · minor aches and pains
· temporarily reduces fever
Children's TYLENOL® Plus Cold & Cough Suspension Liquid and Chewable Tablets: temporarily relieves these cold symptoms:
· nasal congestion · sore throat · runny nose · sneezing · headache · minor aches and pains · coughs
· temporarily reduces fever
Children's Tylenol® Plus Cold Daytime Non-Drowsy Suspension Liquid: temporarily relieves: · sinus congestion · stuffy nose · sinus pressure · minor aches, pains and headache · temporarily reduces fever
DIRECTIONS
See Table 1: Children's Tylenol Dosing Chart on pg. ___
WARNINGS
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied by or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly (does not apply to Concentrated TYLENOL® Infants' Drops Plus Cold or Children's TYLENOL® Plus Cold Daytime Non-Drowsy )
Do not use
- in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
- with any other products containing acetaminophen
Ask a doctor before use if the child has
Concentrated TYLENOL® Infants' Drops Plus Cold and Children's TYLENOL® Plus Cold Daytime Non Drowsy Suspension Liquid
· heart disease · high blood pressure · thyroid disease · diabetes
Concentrated TYLENOL® Infants' Drops Plus Cold & Cough
- heart disease · high blood pressure
- cough that occurs with too much phlegm (mucus)
- thyroid disease · diabetes
- chronic cough that lasts as occurs with asthma
Children's TYLENOL® Plus Cold Nighttime Suspension Liquid and Children's TYLENOL® Plus Cold Chewable Tablets
- heart disease · high blood pressure · thyroid disease
- diabetes · glaucoma
- a breathing problem such as chronic bronchitis
Children's TYLENOL® Plus Cold & Cough Suspension Liquid and Chewable Tablets
- heart disease · high blood pressure
- chronic cough that lasts as occurs with asthma
- thyroid disease · diabetes · glaucoma
- cough that occurs with too much phlegm (mucus)
When using this product
- do not exceed recommended dosage (see overdose warning)
Children's TYLENOL® Plus Cold Nighttime Suspension Liquid, Children's TYLENOL® Plus Cold Chewable Tablets and Children's TYLENOL® Plus Cold & Cough Suspension Liquid and Chewable Tablets
- drowsiness may occur
- excitability may occur, especially in children
Stop use and ask a doctor if
- new symptoms occur
- redness or swelling is present
- pain gets worse or lasts for more than 5 days *for Children's TYLENOL® Plus Cold Daytime Non Drowsy and Nighttime Suspension Liquid: pain or nasal congestion gets worse or lasts more than 5 days *for Children's TYLENOL® Plus Cold & Cough Suspension Liquid: pain, cough, or nasal congestion gets worse or lasts more than 5 days.
- fever gets worse or lasts for more than 3 days
- nervousness, dizziness or sleeplessness occurs
- cough lasts for more than 7 days, comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. ( Concentrated TYLENOL® Infants' Drops Plus Cold & Cough and Children's TYLENOL® Plus Cold & Cough Chewable Tablets only)
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. (Children's Tylenol® Plus Cold & Cough Suspension Liquid only)
Keep out of reach of children
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.
Other Information:
Concentrated TYLENOL® Infants' Drops Plus Cold, Concentrated TYLENOL® Infants' Drops Plus Cold & Cough
- do not use if plastic carton wrap or bottle wrap imprinted "Safety Seal®" is broken or missing
- store at room temperature
- see bottom panel for lot number and expiration date
Children's TYLENOL® Plus Cold & Cough Suspension Liquid, Children's TYLENOL® Plus Cold Nighttime Suspension Liquid and Children's TYLENOL® Plus Cold Daytime Non-Drowsy
- do not use if plastic carton wrap or bottle wrap imprinted "Safety Seal®" is broken or missing
- store between 20°-25°C (68°-77°F)
- see bottom panel for lot number and expiration date
Children's TYLENOL® Plus Cold Chewable Tablets
- phenylketonurics: contains phenylalanine 6 mg per tablet
- do not use if carton is opened or if blister unit is broken
- store at room temperature
- see side panel for lot number and expiration date.
Children's TYLENOL® Plus Cold & Cough Chewable Tablets
- phenylketonurics: contains phenylalanine 4 mg per tablet
- do not use if carton is opened or if blister unit is broken
- store at room temperature
- see side panel for lot number and expiration date
PROFESSIONAL INFORMATION :
OVERDOSAGE INFORMATIONFor overdosage information, please refer to pgs. ___-___
Inactive Ingredients:
Concentrated TYLENOL® Infants' Drops Plus Cold: citric acid, corn syrup, FD&C Red #40, flavors, polyethylene glycol, propylene glycol, sodium benzoate, sodium saccharin.
Concentrated TYLENOL® Infants' Drops Plus Cold & Cough: acesulfame potassium, citric acid, corn syrup, FD&C Red #40, flavors, polyethylene glycol, propylene glycol, sodium benzoate.
Children's TYLENOL® Plus Cold: Nighttime Suspension Liquid: acesulfame potassium, carboxymethylcellulose sodium, cellulose, citric acid, corn syrup, D&C red #33, FD&C blue #1, FD&C red #40, flavors, glycerin, purified water, sodium benzoate, sorbitol, xanthan gum. Chewable Tablets: aspartame, basic polymethacrylate, cellulose, cellulose acetate, citric acid, D&C Red #7, FD&C Blue #1, flavors, hypromellose, magnesium stearate, mannitol.
Children's TYLENOL® Plus Cold & Cough: Suspension Liquid: acesulfame potassium, cellulose, citric acid, corn syrup, D&C Red #33, FD&C Red #40, flavors, glycerin, sodium benzoate, sorbitol, xanthan gum. Chewable Tablets: aspartame, basic polymethacrylate, cellulose, cellulose acetate, D&C Red #7, flavors, hypromellose, magnesium stearate, mannitol.
Children's Tylenol® Plus Cold Daytime Non-Drowsy
acesulfame potassium, carboxymethyl cellulose sodium, cellulose, citric acid, corn syrup, D&C red #33, FD&C red #40, flavors, glycerin, purified water, sodium benzoate, sorbitol, xanthan gum.
HOW SUPPLIED
Concentrated TYLENOL® Infants' Drops Plus Cold: Red colored, Bubble Gum flavored drops in child resistant tamper-evident bottles of 1 / 2 fl. oz.
Concentrated TYLENOL® Infants' Drops Plus Cold & Cough: Red colored, Cherry Flavored drops in Child resistant tamper evident bottles of 1 / 2 fl. oz.
Children's TYLENOL® Plus Cold: Nighttime Suspension Liquid: Purple-colored-bottles of 4 fl. oz. Store between 20°-25°C (68°-77°F). Chewable Tablets: Purple-colored, imprinted "TYLENOL COLD" on one side and "TC" on opposite side- blisters of 24.
Children's TYLENOL® Plus Cold & Cough: Suspension Liquid: Red colored, Cherry flavored liquid in child resistant tamper-evident bottles of 4 fl. oz.
Chewable Tablets: Red-colored, imprinted TYLENOL C/C" on one side and "TC/C" on the opposite side- blisters of 24.
Cold Daytime 4oz is in white (opaque) bottle
Children's Tylenol® Plus Cold Daytime Non-Drowsy
Red-colored, Fruit flavored liquid in child resistant tamper-evident bottles of 4 fl. oz.
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