CHEWABLE ACETAMINOPHEN CHILDRENS- acetaminophen tablet, chewable

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
Available from:
Cardinal Health
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer - temporarily relieves minor aches and pains due to: headache sore throat flu toothache the common cold - headache - sore throat - flu - toothache - the common cold - temporarily reducer fever
Authorization status:
OTC monograph not final
Authorization number:
70000-0310-1

CHEWABLE ACETAMINOPHEN CHILDRENS- acetaminophen tablet, chewable

Cardinal Health

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 44-450

Active ingredient (in each chewable tablet)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:

headache

sore throat

toothache

the common cold

temporarily reducer 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 pr 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 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

do not give for more than 5 days unless directed by a doctor

Weight (lb)

Age (yr)

Dose (chewable tablets)*

Under 24

Under 2

Ask a doctor

24-35

1 tablet

36-47

1 1/2 tablets

48-59

2 tablets

60-71

9-10

2 1/2 tablets

72-95

3 tablets

* or as directed by a doctor

Other information

store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

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, flavor, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose

Questions or comments?

1-800-426-9391

Principal display panel

LEADER™

NDC 70000-0310-1

Children's | Ages 2-11

Chewable Acetaminophen

160 mg Chewable Tablets ι Pain Reliever / Fever Reducer

Bubblegum

Flavor

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

All LEADER™ Brand Products Have A

100% Money Back Guarantee

Return to place of purchase if not satisfied.

CIN 5335336 REV. 1/19

†This product is not manufactured or distributed by Johnson &

Johnson Corporation, owner of the registered trademark Children's

Tylenol

. 50844 REV1018A45008

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OH 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 4 4 -4 50

CHEWABLE ACETAMINOPHEN CHILDRENS

acetaminophen tablet, chewable

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 0 0 0 -0 310

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

16 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

CRO SPO VIDO NE, UNSPECIFIED (UNII: 2S78 30 E56 1)

D&C RED NO . 2 7 ALUMINUM LAKE (UNII: ZK6 4F7XSTX)

D&C RED NO . 3 0 (UNII: 2S42T28 0 8 B)

ETHYLCELLULO SE, UNSPECIFIED (UNII: 7Z8 S9 VYZ4B)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MANNITO L (UNII: 3OWL53L36 A)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

HIGH DENSITY PO LYETHYLENE (UNII: UG0 0 KM4WR7)

DEXTRO SE MO NO HYDRATE (UNII: LX22YL0 8 3G)

Product Characteristics

Color

PINK

S core

2 pieces

S hap e

ROUND

S iz e

16 mm

Flavor

BUBBLE GUM

Imprint Code

44;450

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:70 0 0 0 -0 310 -1

1 in 1 CARTON

0 2/25/20 0 5

1

24 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH NOT FINAL part343

0 2/25/20 0 5

Labeler -

Cardinal Health (097537435)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

0 38 15446 4

PACK(70 0 0 0 -0 310 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 9 4

MANUFACTURE(70 0 0 0 -0 310 )

Cardinal Health

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 37

PACK(70 0 0 0 -0 310 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

9 6 76 26 30 5

PACK(70 0 0 0 -0 310 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 6 8 7340 8 8

PACK(70 0 0 0 -0 310 )

Revised: 10/2019

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