CHILDRENS TYLENOL- acetaminophen tablet, chewable 
McNeil Consumer Healthcare Div. McNeil-PPC, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Children's TYLENOL®

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 80 mg

Purpose

Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
    • the common cold
    • flu
    • headache
    • sore throat
    • toothache
  • temporarily reduces fever

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

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

Ask a doctor before use if your child has liver disease

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

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

Stop use and ask a doctor if

  • 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

These could be signs of a serious condition.

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. (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

  • this product does not contain directions or complete warnings for adult use.
  • do not give more than directed (see overdose warning)
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • chew before swallowing; this product will soften in mouth for ease of chewing
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
Weight (lb)Age (yr)Dose (tablets)*
*
or as directed by a doctor
under 24under 2 yearsask a doctor
24-352-3 years2 tablets
36-474-5 years3 tablets
48-596-8 years4 tablets
60-719-10 years5 tablets
72-9511 years6 tablets

Other information

  • store between 20-25°C (68-77°F). Avoid high humidity.
    Protect from light.
  • do not use if carton is opened, or if neck wrap or foil inner seal imprinted with "SAFETY SEAL®" is broken or missing
  • see end panel for lot number and expiration date

Inactive ingredients

anhydrous citric acid, cellulose acetate, crospovidone, D&C red no. 7 calcium lake, D&C red no. 30 aluminum lake, dextrose excipient, FD&C blue no. 1 aluminum lake, flavor, magnesium stearate, povidone, sucralose

Questions or comments?

call 1-877-895-3665

PRINCIPAL DISPLAY PANEL

NDC 50580-518-30

Children's
TYLENOL®

Pain Reliever
Fever Reducer

Acetaminophen

AGES
2-6

MEDICINE PER TABLET
80
mg

Meltaways™

30 Chewable Tablets

Aspirin Free • Ibuprofen Free

Grape Punch
flavor

PRINCIPAL DISPLAY PANEL
CHILDRENS TYLENOL 
acetaminophen tablet, chewable
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50580-518
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen80 mg
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid 
cellulose acetate 
crospovidone 
D&C red no. 30 
aluminum oxide 
FD&C blue no. 1 
magnesium stearate 
povidones 
sucralose 
Product Characteristics
ColorPURPLEScoreno score
ShapeROUNDSize13mm
FlavorGRAPE (Grape Punch) Imprint Code TY;80
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-518-301 in 1 CARTON
130 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34308/01/200402/13/2014
Labeler - McNeil Consumer Healthcare Div. McNeil-PPC, Inc (878046358)

Revised: 6/2014
Document Id: b06c66b2-2b1a-4af3-93bc-d72dac313727
Set id: 7503b882-a815-4a8a-a845-a1d7e40757b2
Version: 2
Effective Time: 20140610
 
McNeil Consumer Healthcare Div. McNeil-PPC, Inc