CHILDRENS TYLENOL - acetaminophen suspension 
McNeil Consumer Healthcare Div. McNeil-PPC, Inc

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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Drug Facts

Active ingredient (in each 5 mL = 1 teaspoon)

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

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

Taking more than the recommended dose (overdose) may cause liver damage. 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 (tsp or mL)
under 24under 2 yearsask a doctor
24-352-3 years1 tsp or 5 mL
36-474-5 years1 1/2 tsp or 7.5 mL
48-596-8 years2 tsp or 10 mL
60-719-10 years2 1/2 tsp or 12.5 mL
72-9511 years3 tsp or 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, butylparaben, FD&C red #40, 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 1-877-895-3665

PRINCIPAL DISPLAY PANEL

See New Warnings Information

NDC 50580-493-04

Children's
TYLENOL
®

Acetaminophen
Oral Suspension
Fever Reducer, Pain Reliever

AGES 2-11

Pediatricians'
1st Choice

Alcohol Free
Aspirin Free
Ibuprofen Free

very berry
STRAWBERRY

FLAVOR

4 FL OZ (120mL)
80 mg per 1/2 teaspoon (160 mg per 5 mL)

PRINCIPAL DISPLAY PANEL

CHILDRENS TYLENOL 
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-493
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid 
butylparaben 
FD&C red no. 40 
glycerin 
high fructose corn syrup 
cellulose, microcrystalline 
carboxymethylcellulose sodium 
propylene glycol 
water 
sodium benzoate 
sorbitol 
sucralose 
xanthan gum 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:50580-493-011 BOTTLE, PLASTIC ( BOTTLE) in 1 CARTONcontains a BOTTLE, PLASTIC
130 mL in 1 BOTTLE, PLASTICThis package is contained within the CARTON (50580-493-01)
2NDC:50580-493-041 BOTTLE, PLASTIC ( BOTTLE) in 1 CARTONcontains a BOTTLE, PLASTIC
2120 mL in 1 BOTTLE, PLASTICThis package is contained within the CARTON (50580-493-04)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34312/01/200412/31/2011

Labeler - McNeil Consumer Healthcare Div. McNeil-PPC, Inc (878046358)

Revised: 04/2012 McNeil Consumer Healthcare Div. McNeil-PPC, Inc