CHILDRENS TYLENOL- acetaminophen suspension 
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 5 mL = 1 teaspoonful)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily:

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

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

  • 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; tsp = teaspoonful
  • 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 tsp) *
*
or as directed by a doctor
under 24under 2 yearsask a doctor
24-352-3 years5 mL (1 tsp)
36-474-5 years7.5 mL (1½ tsp)
48-596-8 years10 mL (2 tsp)
60-719-10 years12.5 mL (2½ tsp)
72-9511 years15 mL (3 tsp)

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

Other information

  • each 5 mL (1 tsp) contains: sodium 2 mg
  • store between 20-25°C (68-77°F)
  • do not use if carton tape imprinted "TYLENOL" or bottle wrap imprinted "TYLENOL" is broken or missing

Inactive ingredients

anhydrous citric acid, butylparaben, D&C red no. 33, FD&C blue no. 1, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, 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 50580-296-50
See New Warning

Children's
TYLENOL®

Acetaminophen Oral Suspension
Pain Reliever-Fever Reducer

Pain + Fever
Ages 2-11

Ibuprofen Free
Alcohol Free
Aspirin Free

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

Grape
Flavor

Principal Display Panel
CHILDRENS TYLENOL 
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-296
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)  
butylparaben (UNII: 3QPI1U3FV8)  
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)  
propylene glycol (UNII: 6DC9Q167V3)  
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:50580-296-501 in 1 CARTON11/26/201206/30/2019
1120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
2NDC:50580-296-512 in 1 PACKAGE01/16/201306/30/2019
21 in 1 CARTON
2120 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 FINALpart34307/01/200406/30/2019
Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)

Revised: 9/2020
 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division