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Chewable Acetaminophen Childrens

Dosage form: tablet, chewable
Ingredients: ACETAMINOPHEN 160mg
Labeler: Cardinal Health
NDC Code: 70000-0309

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.

Leader 44-449

Active ingredient (in each tablet)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses
  • temporarily relieves minor aches and pains due to:
  • headache
  • sore throat
  • flu
  • toothache
  • the common cold
  • 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 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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
  • 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 before swallowing; this product will soften in mouth for ease of chewing
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • do not give for more than 5 days unless directed by a doctor
Weight (lb)Age (yr)Dose (tablets)*
Under 24Under 2Ask a doctor
24-352-31
36-474-51 1/2
48-596-82
60-719-102 1/2
72-95113

*or as directed by a doctor

Other information
  • 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

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 | Ages 2-11

Chewable Acetaminophen
Acetaminophen, 160 mg | Pain Reliever / Fever Reducer

Grape
Flavor

Aspirin Free
Ibuprofen Free

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 5335328                           REV. 5/17

This product is not manufactured or distributed by Johnson & Johnson
Corporation, owner of the registered trademark Children’s Tylenol®.
50844 ORG101644908

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

CARDINAL HEALTH, the Cardinal Health LOGO, LEADER,
and the Leader LOGO are trademarks or registered
trademarks of Cardinal Health.

Leader 44-449 ORG1016

CHEWABLE ACETAMINOPHEN  CHILDRENS
acetaminophen tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0309
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN160 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
CROSPOVIDONE, UNSPECIFIED 
D&C RED NO. 27 
D&C RED NO. 30 
ETHYLCELLULOSE, UNSPECIFIED 
FD&C BLUE NO. 1 
MAGNESIUM STEARATE 
MANNITOL 
STEARIC ACID 
SUCRALOSE 
Product Characteristics
ColorPURPLEScore2 pieces
ShapeROUNDSize16mm
FlavorGRAPEImprint Code44;449
Contains    
Packaging
#Item CodePackage Description
1NDC:70000-0309-11 BOTTLE, PLASTIC in 1 CARTON
124 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34301/28/2005
Labeler - Cardinal Health (097537435)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(70000-0309)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(70000-0309)

Revised: 05/2017
 
Cardinal Health

← See all Chewable Acetaminophen Childrens brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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