CHILDRENS TYLENOL- acetaminophen 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

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

Childrens Tylenol

Drug Facts

Active ingredient (in each chewable tablet)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

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

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

  • skin reddening
  • blisters
  • rash

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

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

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

Weight (lb)Age (yr)Dose (tablets) *
*
or as directed by a doctor
under 24under 2 yearsask a doctor
24-35 lbs2-3 years1 tablet
36-47 lbs4-5 years1½ tablets
48-59 lbs6-8 years2 tablets
60-71 lbs9-10 years2½ tablets
72-95 lbs11 years3 tablets

Other information

Inactive ingredients

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

Questions or comments?

call 1-800-458-1635 (toll-free) or 215-273-8755 (collect)

Childrens Tylenol

Drug Facts

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily:

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

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

  • skin reddening
  • blisters
  • rash

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

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

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

Weight (lb)Age (yr)Dose (mL) *
*
or as directed by a doctor
under 24under 2 yearsask a doctor
24-35 lbs2-3 years5 mL
36-47 lbs4-5 years7.5 mL
48-59 lbs6-8 years10 mL
60-71 lbs9-10 years12.5 mL
72-95 lbs11 years15 mL

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

Other information

Inactive ingredients

anhydrous citric acid, D&C red no. 33, FD&C blue no. 1, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Questions or comments?

call 1-800-458-1635 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

NDC 50580-460-01

Children's
TYLENOL
®

Acetaminophen (160 mg per 5 mL)
Oral Suspension

Pain Reliever-Fever Reducer

Pain+Fever
Ages 2-11 Years

Ibuprofen Free
Alcohol Free
Aspirin Free

No Parabens

4 fl oz (120 mL)
160 mg per 5 mL


Grape
Flavor

BE READY

AT HOME

OR

ON-THE-GO

Use products only as directed

NDC 50580-460-01

Children's
TYLENOL
®

Acetaminophen
Pain Reliever
Fever Reducer

Pain+Fever
Ages 2-11
Chewables

Chew or crush tablets completely
before swallowing


Ibuprofen Free

Aspirin Free


160 mg
Per Tablet

24
Chewable
Tablets

Actual Size

160 mg each

Grape Flavor

Childrens Tylenol-1

CHILDRENS TYLENOL 
acetaminophen kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-460
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-460-011 in 1 PACKAGE05/07/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 24 
Part 21 BOTTLE 120 mL
Part 1 of 2
CHILDRENS TYLENOL 
acetaminophen tablet, chewable
Product Information
Item Code (Source)NDC:50580-522
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg
Inactive Ingredients
Ingredient NameStrength
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
CELLULOSE ACETATE (UNII: 3J2P07GVB6)  
CROSPOVIDONE (UNII: 2S7830E561)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
Product Characteristics
ColorpurpleScore2 pieces
ShapeROUNDSize16mm
FlavorGRAPEImprint Code TY;160;HALF;HALF
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-522-241 in 1 CARTON
124 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34302/27/2017
Part 2 of 2
CHILDRENS TYLENOL 
acetaminophen suspension
Product Information
Item Code (Source)NDC:50580-612
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorpurpleScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-612-011 in 1 CARTON
1120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34308/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34305/07/2018
Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)

Revised: 12/2022
Document Id: f05285a5-f6fc-778f-e053-2995a90a5a77
Set id: babcb210-6a47-46ef-b4ea-bdde80411cd3
Version: 7
Effective Time: 20221221
 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division