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 INFORMATION

For 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.

PRODUCT PHOTO(S):

NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size.

The product samples shown here have been supplied by the manufacturer and reproduced in full color by PDR as a quick-reference identification aid. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected overdosage, the drug's identity should be verified by chemical analysis.