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.