OTC Medication Information: Childrens TYLENOL

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.

Drug Facts

Active ingredient (in each 5 mL)

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
  • 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 as directed by a doctor
    under 24under 2 yearsask a doctor
    24-35 lbs2-3 years5 mL
    36-47 lbs4-5 years7.5 mL
    48-59 lbs6-8 years10 mL
    60-71 lbs9-10 years12.5 mL
    72-95 lbs11 years15 mL

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 contains: potassium 5 mg
  • store between 20-25°C (68-77°F)
  • do not use if carton tape or 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 or comments?

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

PRINCIPAL DISPLAY PANEL

NDC 50580-170-01

Children’s TYLENOL ®

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

DYE-FREE

Pain + Fever

Ages 2-11 Years

Free of:

  • Dyes
  • Alcohol
  • Ibuprofen
  • Aspirin
  • Parabens
  • High Fructose

Corn Syrup

Cherry Flavor

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

tylenol-01
(click image for full-size original)
CHILDRENS TYLENOL
acetaminophen suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-170
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 160 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
GLYCERIN
MICROCRYSTALLINE CELLULOSE
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
POTASSIUM SORBATE
WATER
SORBITOL SOLUTION
SUCRALOSE
SUCROSE
XANTHAN GUM
Product Characteristics
Color white Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50580-170-01 1 BOTTLE in 1 CARTON contains a BOTTLE
1 120 mL in 1 BOTTLE This package is contained within the CARTON (50580-170-01)
2 NDC:50580-170-03 2 CARTON in 1 PACKAGE contains a CARTON
2 1 BOTTLE in 1 CARTON This package is contained within the PACKAGE (50580-170-03) and contains a BOTTLE
2 120 mL in 1 BOTTLE This package is contained within a CARTON and a PACKAGE (50580-170-03)
3 NDC:50580-170-02 1 BOTTLE in 1 CARTON contains a BOTTLE
3 240 mL in 1 BOTTLE This package is contained within the CARTON (50580-170-02)
4 NDC:50580-170-04 3 CARTON in 1 PACKAGE contains a CARTON
4 1 BOTTLE in 1 CARTON This package is contained within the PACKAGE (50580-170-04) and contains a BOTTLE
4 120 mL in 1 BOTTLE This package is contained within a CARTON and a PACKAGE (50580-170-04)
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: 11/2021 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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