Label: CHILDRENS TYLENOL- acetaminophen suspension
- NDC Code(s): 50580-139-04, 50580-139-08
- Packager: Kenvue Brands LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 23, 2025
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
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Warnings
Liver warning
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 acetaminophenAllergy 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 -
Directions
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
■ 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 hoursWeight (lb) Age (yr) Dose (mL)* under 24 under 2 years ask a doctor 24-35 lbs 2-3 years 5 mL 36-47 lbs 4-5 years 7.5 mL 48-59 lbs 6-8 years 10 mL 60-71 lbs 9-10 years 12.5 mL 72-95 lbs 11 years 15 mL
* or as directed by a doctor
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device. - Other information
- Inactive ingredients
- QUESTIONS
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PRINCIPAL DISPLAY PANEL
NDC 50580-139-04
NEW
Children's TYLENOL ®
Acetaminophen (160 mg per 5 mL)
Oral Suspension
Pain Reliever-Fever Reducer
Pain+Fever
Ages 2-11 Years
DYE-FREE
Free Of:
• Dyes
• Alcohol
• Ibuprofen
• Aspirin
• Parabens
• High Fructose Corn Syrup
• Artificial Flavoring
Natural Apple
Flavor with Other
Natural Flavors4 fl oz (120 mL) 160 mg per 5 mL
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INGREDIENTS AND APPEARANCE
CHILDRENS TYLENOL
acetaminophen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-139 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 SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCROSE (UNII: C151H8M554) XANTHAN GUM (UNII: TTV12P4NEE) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SUCRALOSE (UNII: 96K6UQ3ZD4) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) SORBITOL SOLUTION (UNII: 8KW3E207O2) SODIUM BENZOATE (UNII: OJ245FE5EU) WATER (UNII: 059QF0KO0R) Product Characteristics Color white (White to off-white) Score Shape Size Flavor APPLE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50580-139-04 1 in 1 CARTON 04/28/2025 1 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:50580-139-08 1 in 1 CARTON 06/30/2025 2 240 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 04/28/2025 Labeler - Kenvue Brands LLC (118772437)