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.


Children's TYLENOL ®

Drug Facts

Active ingredient (in each 5 mL)

Acetaminophen 160 mg


Pain reliever/fever reducer




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.


Weight (lb) Age (yr) Dose (mL) *
or as directed by a doctor
under 24 under 2 years ask a doctor
24-35 2-3 years 5 mL
36-47 4-5 years 7.5 mL
48-59 6-8 years 10 mL
60-71 9-10 years 12.5 mL
72-95 11 years 15 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)


NDC 50580-579-02


Acetaminophen (160 mg per 5 mL)
Oral Suspension
Pain Reliever-Fever Reducer


Ages 2-11 Years

For In-Patient Use Only
Not For Retail Sale

Ibuprofen Free
Alcohol Free
Aspirin Free

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


acetaminophen suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-579
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 160 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
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)
carboxymethylcellulose sodium, unspecified form (UNII: K679OBS311)
water (UNII: 059QF0KO0R)
sodium benzoate (UNII: OJ245FE5EU)
sorbitol (UNII: 506T60A25R)
sucralose (UNII: 96K6UQ3ZD4)
xanthan gum (UNII: TTV12P4NEE)
Product Characteristics
Color PURPLE Score
Shape Size
Flavor GRAPE Imprint Code
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50580-579-02 1 in 1 CARTON 01/16/2017
1 120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 01/16/2017
Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)

Revised: 12/2017
Document Id: 23731061-2dc3-4b44-8a10-aa359170ed23
Set id: ce0a1fbc-7345-462b-b0da-c7149bdc288c
Version: 3
Effective Time: 20171226
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division