OTC Medication Information: Childrens TYLENOL

CHILDRENS TYLENOL- acetaminophen tablet, chewable
Johnson & Johnson Consumer Inc.

Drug Facts

Active ingredient (in each chewable tablet)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
    • the common cold
    • flu
    • headache
    • sore throat
    • toothache
  • temporarily reduces fever

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)
  • chew or crush tablets completely before swallowing; do not swallow tablets whole
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
Weight (lb) Age (yr) Dose (tablets) *
*
or as directed by a doctor
under 24 under 2 years ask a doctor
24-35 2-3 years 1 tablet
36-47 4-5 years 1½ tablets
48-59 6-8 years 2 tablets
60-71 9-10 years 2½ tablets
72-95 11 years 3 tablets

Other information

  • store between 20-25°C (68-77°F). Avoid high humidity. Protect from light.
  • do not use if neck band or foil inner seal imprinted with “TYLENOL” is broken or missing

Inactive ingredients

anhydrous citric acid, cellulose acetate, crospovidone, D&C red no. 7 calcium lake, dextrose, flavor, magnesium stearate, povidone, sucralose

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

NDC 50580-521-24

Children’s
TYLENOL ®

Acetaminophen
Pain Reliever
Fever Reducer

Ibuprofen Free

Aspirin Free

Pain+Fever Ages 2-11

Chewables

Chew or crush tablets completely

before swallowing


160 mg
Per Tablet

24 Chewable Tablets
160 mg each

Actual Size

Bubble Gum Flavor

Childrens Tylenol_521
(click image for full-size original)
CHILDRENS TYLENOL
acetaminophen tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-521
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 160 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
CELLULOSE ACETATE
D&C RED NO. 7
DEXTROSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
POVIDONE, UNSPECIFIED
SUCRALOSE
CROSPOVIDONE
Product Characteristics
Color pink Score 2 pieces
Shape ROUND Size 16mm
Flavor BUBBLE GUM Imprint Code TY;160;HALF;HALF
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50580-521-24 1 BOTTLE in 1 CARTON contains a BOTTLE
1 24 TABLET, CHEWABLE in 1 BOTTLE This package is contained within the CARTON (50580-521-24)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M013 02/27/2017
Labeler — Johnson & Johnson Consumer Inc. (878046358)

Revised: 03/2024 Johnson & Johnson Consumer Inc.

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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