INFANTS TYLENOL- acetaminophen suspension

Drug Labeling and Warnings

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpose

Purpose

Pain reliever/fever reducer

Uses

Uses temporarily:

■ reduces fever

■ relieves minor aches and pains due to:

-the common cold

-flu

-headache

-sore throat

-toothache

Warnings

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 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

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.

■ push air out of syringe. Insert syringe tip into bottle opening

■ flip bottle upside down. Pull yellow part of syringe to correct dose

■ dispense liquid slowly into child’s mouth, toward inner cheek

■ repeat dose every 4 hours while symptoms last

■ do not give more than 5 times in 24 hours

■ replace cap tightly to maintain child resistance

Dosing Chart

Weight (lb)	Age (yr)	Dose (mL)*
under 24	under 2 years	ask a doctor
24-35 lbs	2-3 years	5 mL

* or as directed by a doctor

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

Other information

Other information

■ each 5 mL contains: potassium 5 mg
■ store between 20-25°C (68-77°F)

■ do not use if carton is opened

■ do not use if bottle wrap imprinted with “TYLENOL” is broken or missing

Inactive ingredients

anhydrous citric acid, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, potassium sorbate, purified water, sorbitol solution, sucralose, sucrose, xanthan gum

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

NEW

NDC: 50580-154-02

Infant's TYLENOL ®

For children

Acetaminophen (160 mg per 5 mL)

Oral Suspension

Pain Reliever-Fever Reducer

Pain+Fever

Infants

DYE-FREE

Free Of:

Dyes
Alcohol
Ibuprofen
Aspirin
Parabens
High Fructose Corn Syrup
Artificial Flavoring

Natural Apple
Flavor with Other
Natural Flavors

2 fl oz (60 mL) 160 mg per 5 mL*

*Same as Children’s TYLENOL®

SimpleMeasure®

Specially designed for younger children
Use Only Enclosed Syringe

INGREDIENTS AND APPEARANCE

INFANTS TYLENOL  
acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50580-154
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
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)
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: 50580-154-02	1 in 1 CARTON	04/13/2026
1		60 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	04/13/2026

Labeler - Kenvue Brands LLC (118772437)