CHILDRENS TYLENOL- acetaminophen tablet, chewable 
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

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
24-352-3 years1 tablet
36-474-5 years1½ tablets
48-596-8 years2 tablets
60-719-10 years2½ tablets
72-9511 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)

PRINCIPAL DISPLAY PANEL

NDC 50580-522-24

Children's

TYLENOL ®

Acetaminophen

Pain Reliever
Fever Reducer

Ibuprofen Free

Aspirin Free

Pain+Fever

Ages 2-11

Chewables

Chew or crush tablets completely

before swallowing


160 mg

Per Tablet

24 Chewable Tablets

160 mg each

Actual Size

Grape Flavor

Childrens Tylenol_522

CHILDRENS TYLENOL 
acetaminophen tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem 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
CROSPOVIDONE (UNII: 2S7830E561)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CELLULOSE ACETATE (UNII: 3J2P07GVB6)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
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)  
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 CARTON02/27/2017
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
Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)

Revised: 12/2021
Document Id: d393fdbe-e8ba-eb6c-e053-2a95a90a99fe
Set id: 9782fe86-d72a-4231-b1ba-d3f3b4ee49e3
Version: 5
Effective Time: 20211220
 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division