CHILDRENS TYLENOL- acetaminophen powder 
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 powder)

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 (powder)*
*
or as directed by a doctor
under 48under 6 yearsdo not use
48-596-8 years2 powders
60-719-10 years2 powders
72-9511 years3 powders

Other information

Inactive ingredients

citric acid, ethylcellulose, flavor, magnesium stearate, maltodextrin, sodium bicarbonate, sucralose, xylitol

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

NDC 50580-555-05

Children's
TYLENOL®

Acetaminophen
Pain Reliever-Fever Reducer

Ibuprofen Free
Aspirin Free

Pain+Fever Ages 6-11

DISSOLVE PACKS

NO WATER NEEDED
DISSOLVES IN SECONDS
DYE-FREE

18 Packets*
160 mg each packet

Wild Berry
Flavor
*Packets of Powder

PRINCIPAL DISPLAY PANEL
CHILDRENS TYLENOL 
acetaminophen powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-555
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen160 mg
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid (UNII: XF417D3PSL)  
ethylcellulose, unspecified (UNII: 7Z8S9VYZ4B)  
magnesium stearate (UNII: 70097M6I30)  
maltodextrin (UNII: 7CVR7L4A2D)  
sodium bicarbonate (UNII: 8MDF5V39QO)  
sucralose (UNII: 96K6UQ3ZD4)  
xylitol (UNII: VCQ006KQ1E)  
Product Characteristics
ColorWHITE (off white) Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-555-0430 in 1 CARTON07/15/2019
11 in 1 PACKET; Type 0: Not a Combination Product
2NDC:50580-555-0518 in 1 CARTON07/15/2019
21 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34307/15/2019
Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)

Revised: 7/2020
Document Id: d35cd5db-4fc9-4639-946b-ed29214125a9
Set id: 79669930-f744-4bb1-8325-b75951489b64
Version: 2
Effective Time: 20200709
 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division