FDA.reportPublic FDA data

Leader 44-449

Manufacturer
Cardinal Health 110, LLC. DBA Leader | LNK International, Inc.
Effective date
2026-04-02
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-06-01 01:52:37

Label at a glance#

ProductChewable Acetaminophen Childrens
Active ingredientACETAMINOPHEN
Label structure9 sections

Indications and uses

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

Dosage and administration

this product does not contain directions or complete warnings for adult use do not give more than directed find the right dose on chart below. If possible, use weight to dose; otherwise, use age. chew or crush tablets completely before swallowing; do not swallow tablets whole repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (chewable tablets)* Under ...

Storage and handling

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) avoid high humidity see end flap for expiration date and lot number

Label contents#

Full prescribing information#

Active ingredient (in each chewable tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 160 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if your child has

OTC - ASK DOCTOR SECTION

liver disease.

Ask a doctor or pharmacist before use if your child is

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • any new symptoms appear

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed
  • find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • chew or crush tablets completely before swallowing; do not swallow tablets whole
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
Weight (lb)Age (yr)Dose (chewable tablets)*
Under 24Under 2Ask a doctor
24-352-31 tablet
36-474-51 1/2 tablets
48-596-82 tablets
60-719-102 1/2 tablets
72-95113 tablets

*or as directed by a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • avoid high humidity
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavors, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER™

NDC 70000-0309-1

Children's
Chewable Acetaminophen
160 mg Chewable Tablets | Pain Reliever / Fever Reducer

Grape Flavor
Ages 2 - 11
Aspirin-Free
Ibuprofen-Free
Chew or crush tablets
completely before swallowing.

24 CHEWABLE TABLETS

ACTUAL SIZE

COMPARE TO CHILDREN’S
TYLENOL® CHEWABLES
active ingredient†

100% Money Back Guarantee

TAMPER EVIDENT: DO NOT USE IF
IMPRINTED SAFETY SEAL UNDER
CAP IS BROKEN OR MISSING

100% Money Back Guarantee
Return to place of purchase if not satisfied.

CIN 5335328          REV. 02/25

†This product is not manufactured or distributed by Kenvue
Inc., owner of the registered trademark Children’s Tylenol®
Chewables.      50844       REV0424C44908

©2025 Cardinal Health. CARDINAL HEALTH, the Cardinal Health
LOGO, LEADER, and the LEADER LOGO are trademarks or
registered trademarks of Cardinal Health. All other marks are
the property of their respective owners.

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com
1-800-200-6313

Leader 44-449
Leader 44-449

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313820acetaminophen 160 MG Chewable TabletPSN12
313820acetaminophen 160 MG Chewable TabletSCD12
313820APAP 160 MG Chewable TabletSY12

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130096295132243GTIN-13: 0096295132243
EAN-13: 0096295132243
GTIN-12: 096295132243
UPC-A: 096295132243
GTIN storage (14 digits): 00096295132243		leader-44-449-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0309-1Chewable AcetaminophenChildrens24 in 1 BOTTLE, PLASTICTABLET, CHEWABLE2412
70000-0309-1Chewable AcetaminophenChildrens1 in 1 CARTONTABLET, CHEWABLE112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0309-1EA - Each70000-0309106fca47-a1f5-4572-9822-c4ca5e80845912019-06-19

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-030970000-0309-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CROSPOVIDONE, UNSPECIFIED2S7830E561IACT
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
D&C RED NO. 30 ALUMINUM LAKEGE75M6YV5WIACT
DEXTROSE MONOHYDRATELX22YL083GIACT
ETHYLCELLULOSE, UNSPECIFIED7Z8S9VYZ4BIACT
FD&C BLUE NO. 1 ALUMINUM LAKEJ9EQA3S2JMIACT
MAGNESIUM STEARATE70097M6I30IACT
MANNITOL3OWL53L36AIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
STEARIC ACID4ELV7Z65APIACT
SUCRALOSE96K6UQ3ZD4IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Chewable Acetaminophen ChildrensACETAMINOPHENCardinal Health 110, LLC. DBA Leader8a18565c-b84e-43f8-8e96-e1dbcc39f08b2026-04-02WarningsExact identifier
ndc (package): 70000-0309-1
ndc (product): 70000-0309
ndc11 (package): 70000030901
spl id: d856ac50-a8ec-430c-b137-1791002e28c8
spl set id: 8a18565c-b84e-43f8-8e96-e1dbcc39f08b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.