CHEWABLE ACETAMINOPHEN CHILDRENS- acetaminophen tablet, chewable 
Cardinal Health 110, LLC. DBA Leader

----------

Leader 44-449

Active ingredient (in each chewable tablet)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

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 dosage.

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.

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

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

Inactive ingredients

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?

1-800-426-9391

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®

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 5335326    REV. 9/22

**This product is not manufactured or distributed by Johnson & Johnson
Corporation, owner of the registered trademark Children’s Tylenol®.
50844       REV0522B44908

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

©2022 CARDINAL HEALTH, LEADER, and
LOGOs are trademarks of Cardinal
Health. All other marks are the property
of their respective owners.

Leader 44-449

Leader 44-449

CHEWABLE ACETAMINOPHEN  CHILDRENS
acetaminophen tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0309
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorpurpleScore2 pieces
ShapeROUNDSize16mm
FlavorGRAPEImprint Code 44;449
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0309-11 in 1 CARTON01/28/2005
124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01301/28/2005
Labeler - Cardinal Health 110, LLC. DBA Leader (063997360)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(70000-0309)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837manufacture(70000-0309) , pack(70000-0309)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(70000-0309)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.117025878manufacture(70000-0309)

Revised: 10/2023
Document Id: 28eefc42-57cb-449b-bedb-5ee2ff2744a8
Set id: 8a18565c-b84e-43f8-8e96-e1dbcc39f08b
Version: 9
Effective Time: 20231018
 
Cardinal Health 110, LLC. DBA Leader