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Childrens TYLENOL


SPL UNCLASSIFIED SECTION

Drug Facts


Active ingredient (in each 5 mL)

Acetaminophen 160 mg


Purpose

Pain reliever/fever reducer


Uses

temporarily:

  • reduces fever
  • relieves minor aches and pains due to: the common coldfluheadachesore throattoothache

Warnings


Liver warning

This product contains acetaminophen. Severe liver damage may occur if your child takes

  • more than 5 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen

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Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

  • skin reddening
  • blisters
  • rash

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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

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if your child is allergic to acetaminophen or any of the inactive ingredients in this product

OTC - ASK DOCTOR SECTION

Ask a doctor before use if your child has liver disease


OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin


OTC - WHEN USING SECTION

When using this product do not exceed recommended dose (see overdose warning)


Stop use and ask a doctor if

These could be signs of a serious condition.

  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.


Overdose warning

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


Directions

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

  • this product does not contain directions or complete warnings for adult use.
  • do not give more than directed (see overdose warning)
  • shake well before using
  • mL = milliliter
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • remove the child protective cap and squeeze your child's dose into the dosing cup
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours Weight (lb)Age (yr)Dose (mL) or as directed by a doctorunder 24under 2 yearsask a doctor24-35 lbs2-3 years5 mL36-47 lbs4-5 years7.5 mL48-59 lbs6-8 years10 mL60-71 lbs9-10 years12.5 mL72-95 lbs11 years15 mL

Other information

  • each 5 mL contains: potassium 5 mg
  • store between 20-25°C (68-77°F)
  • do not use if carton is opened
  • do not use if bottle wrap imprinted with “TYLENOL” is broken or missing

Inactive ingredients

anhydrous citric acid, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, potassium sorbate, purified water, sorbitol solution, sucralose, sucrose, xanthan gum


Directions

Weight (lb) Age (yr) Dose (mL) *

under 24 under 2 years ask a doctor

24-35 lb 2-3 years 5 mL 36-47 lb 4-5 years 7.5 mL 48-59 lb 6-8 years 10 mL 60-71 lb 9-10 years 12.5 mL 72-95 lb 11 years 15 mL

*or as directed by a doctor