Children's Tylenol Plus Cold & Allergy Suspension Liquid (McNeil Consumer)

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DESCRIPTION

Children's TYLENOL® Plus Cold & Allergy is Bubble Gum flavored and contains no alcohol or aspirin. Each teaspoon (5 mL) contains acetaminophen 160 mg, diphenhydramine HCl 12.5 mg and pseudoephedrine HCl 15 mg.

ACTIONS

Children's TYLENOL® Plus Cold & Allergy combines the analgesic-antipyretic acetaminophen with the antihistamine diphenhydramine hydrochloride and the decongestant pseudoephedrine hydrochloride to provide fast, effective, temporary relief of all your child's symptoms associated with hay fever and other respiratory allergies including sneezing, sore throat, itchy throat, itchy/watery eyes, runny nose, stuffy nose and nasal congestion. Acetaminophen is equal to aspirin in analgesic and antipyretic effectiveness and it is unlikely to produce the side effects often associated with aspirin or aspirin-containing products.

USES

• temporarily relieves:
  
  • runny nose
  • sneezing
  • itchy watery eyes
  • stuffy nose
  • sore throat
  • minor aches and pains
  • 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 or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

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 product containing acetaminophen.
• with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if the child has

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

When using this product

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

Stop use and ask a doctor if

• pain or nasal congestion gets worse or lasts for more than 5 days
• fever gets worse or lasts for more than 3 days
• redness or swelling is present
• new symptoms occur
• nervousness, dizziness or sleeplessness occurs

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 (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Other Information:

• 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 of carton for lot number and expiration date

PROFESSIONAL INFORMATION :
OVERDOSAGE INFORMATION

For overdosage information, please refer to pgs. ___ - ___.

Inactive Ingredients:

carboxymethylcellulose sodium, cellulose, citric acid, corn syrup, D&C red #33, FD&C red #40, flavors, glycerin, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

HOW SUPPLIED

Pink-colored, Bubble Gum flavored liquid in child resistant tamper-evident bottles of 4 fl. oz.

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