Concentrated tylenol infants' drops plus cold and cough

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.

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

DIRECTIONS

See Table 1: Children's Tylenol Dosing Chart on pg. ___

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 )

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

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.

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 Tyl. Plus Cold N.T. liquid: pain or nasal congestion gets worse or lasts more than 5 days *for Children's TYLENOL cold plus cough suspension liquid:--pain, cough, or nasal congestion gets worse or lasts more than 5 days.--comes back or occurs with rash or headache that lasts. These could be signs of a serious condition
• 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 Products only)

Concentrated TYLENOL Infants' Drops Plus Cold,

Ask a doctor before use if the child has

· heart disease · high blood pressure · thyroid disease · diabetes

When using this product

• do not exceed recommended dosage (see overdose warning)

Concentrated TYLENOL Infants' Drops Plus Cold & Cough

Ask a doctor before use if the child has

• heart disease · high blood pressure
• cough that occurs with too much phlegm (mucus) · thyroid disease · diabetes · chronic cough that lasts as occurs with asthma

When using this product

• do not exceed recommended dosage (see Overdose warning)

Children's TYLENOL Plus Cold Nighttime Suspension Liquid and Plus Cold Chewable Tablets

Ask a doctor before use if the child has

• heart disease · thyroid disease · glaucoma · high blood pressure · diabetes
• a breathing problem such as chronic bronchitis

When using this product

• do not exceed recommended dosage (see overdose warning)
• drowsiness may occur
• excitability may occur, especially in children

Children's TYLENOL Plus Cold & Cough Nighttime Suspension Liquid and Chewable Tablets

Ask a doctor before use if the child has

• heart disease · thyroid disease · glaucoma · high blood pressure · diabetes
• cough that occurs with too much phlegm (mucus)
• chronic cough that lasts as occurs with asthma

When using this product

• do not exceed recommended dosage (see overdose warning)
• drowsiness may occur
• excitability may occur, especially in children

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

Children's TYLENOL Plus Cold & Cough Suspension Liquid, Children's TYLENOL Plus Cold Nighttime Suspension Liquid

• do not use if bottle wrap or foil inner seal imprinted "Safety Seal" is broken or missing
• store between 20°-25°C (68°-77°F)

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

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

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, propylene glycol, 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, carboxymethylcellulose sodium, cellulose, citric acid, corn syrup, D&C Red #33, FD&C Red #40, flavors, glycerin, purified water, sodium benzoate, sorbitol, xanthan gum. Chewable Tablets: aspartame, basic polymethacrylate, cellulose, cellulose acetate, D&C Red #7, flavors, hypromellose, magnesium stearate, mannitol.

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.

Check cold bottle color - clear or white (opaque)

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. 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.