Childrens Pain Reliever

Manufacturer: CARDINAL HEALTH | LNK International, Inc.
Effective date: 2017-08-30
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: legacy-cache
Hydrated at: 2026-08-02 01:12:31

Label at a glance#

ProductChildrens Pain Reliever

Active ingredientACETAMINOPHEN

Label structure9 sections

Indications and uses

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

Dosage and administration

this product does not contain directions or complete warnings for adult use dissolve in mouth or chew before swallowing find the right dose on chart. If possible, use weight to dose; otherwise, use age. if needed, 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) Tablets under 24 under 2 ...

Storage and handling

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

Contacts and useful links#

PhoneLabel contact1-800-426-9391

PhoneLabel contact1-800-200-6313

Websitewww.myleader.com

www.myleader.com

Label contents#

Full prescribing information#

Active ingredient(in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 80 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever / fever reducer

Uses

INDICATIONS & USAGE SECTION

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

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.
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

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.

When using this product

OTC - WHEN USING SECTION

do not exceed recommended dosage.

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
new symptoms occur
redness or swelling is present

These could be signs of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical 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
dissolve in mouth or chew before swallowing
find the right dose on chart. If possible, use weight to dose; otherwise, use age.
if needed, 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)	Tablets
under 24	under 2	Ask a doctor
24-35	2-3	2
36-47	4-5	3
48-59	6-8	4
60-71	9-10	5
72-95	11	6

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrose, ethylcellulose, flavors, magnesium stearate, mannitol, polyethylene, povidone, stearic acid, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER®

NDC 37205-516-65

AGES 2-6

Compare to Children's Tylenol® Meltaways® active ingredient*

CHILDREN'S
Pain Reliever

Acetaminophen 80 mg
Pain Reliever/Fever Reducer

Ibuprofen Free
Aspirin Free Rapid Melts

30 TABLETS

Bubble Gum Flavor

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

50844 REV0412C44701

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017

CIN 3674793
www.myleader.com
1-800-200-6313

All Leader® Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.
Leader 44-447

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0096295113594	GTIN-13: 0096295113594 EAN-13: 0096295113594 GTIN-12: 096295113594 UPC-A: 096295113594 GTIN storage (14 digits): 00096295113594	leader-44-447-1.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
37205-516-65	EA - Each	37205-516	ecb71cb1-9ae8-4663-99af-4eff38d5bce5	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	1
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	1
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	1
DEXTROSE	INACTIVE INGREDIENT	IY9XDZ35W2	1
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	1

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

Childrens Pain Reliever
Acetaminophen
CITRIC ACID MONOHYDRATE
D&C RED NO. 27
D&C RED NO. 30
ETHYLCELLULOSES
MAGNESIUM STEARATE
MANNITOL
POVIDONE
STEARIC ACID
SUCRALOSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
37205-516	37205-516-65

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ACETAMINOPHEN	362O9ITL9D	ACTIB
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
D&C RED NO. 27	2LRS185U6K	IACT
D&C RED NO. 30	2S42T2808B	IACT
ETHYLCELLULOSES	7Z8S9VYZ4B	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MANNITOL	3OWL53L36A	IACT
POVIDONE	FZ989GH94E	IACT
STEARIC ACID	4ELV7Z65AP	IACT
SUCRALOSE	96K6UQ3ZD4	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 316 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TROCHE / ORAL		60 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	LOZENGE / BUCCAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	GRANULE, FOR SUSPENSION / ORAL		23 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INHALANT / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET / ORAL		3391 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		105 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SHAMPOO / TOPICAL		17 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		1000 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / INTRAVENOUS		396 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	WAFER / ORAL	66 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / RESPIRATORY (INHALATION)	0.13 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	LOZENGE / ORAL		115 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		53 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	TABLET, EXTENDED RELEASE / ORAL		1120 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	SHAMPOO / TOPICAL	9.7 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, SOLUTION / INTRAVENOUS		15400 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	POWDER, FOR SUSPENSION / INTRAMUSCULAR	6.75 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS		181 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED / ORAL		176 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	TROCHE / ORAL	903.5 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	INJECTION, SOLUTION / INTRAVENOUS	51.7 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SOLUTION / INTRAVENOUS		15400 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION / INTRAVENOUS		15200 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SYSTEM / IONTOPHORESIS	0.2 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	POWDER, FOR SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET / SUBLINGUAL		24 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	TABLET, COATED / ORAL	20 mg		Exact identifier — unii candidate 14 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / INTRAVENOUS		10 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SYSTEM / TOPICAL	0.2 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CREAM / TOPICAL		190 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	TABLET, FILM COATED / ORAL	83 mg		Exact identifier — unii candidate 14 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	POWDER, FOR SUSPENSION / ORAL	NA		Exact identifier — unii candidate 14 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, DELAYED RELEASE / ORAL		1060 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	LOZENGE / ORAL		20546 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / OPHTHALMIC	0.03 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TROCHE / ORAL	30 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	CAPSULE, EXTENDED RELEASE / ORAL		160 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / BUCCAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	300 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	FILM / SUBLINGUAL		10 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	INJECTION / INTRAVENOUS	5 %w/v		Exact identifier — unii candidate 21 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	AEROSOL, FOAM / RECTAL		7 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, SUSPENSION / INTRAVENOUS	2.5 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, ORALLY DISINTEGRATING / ORAL		4364 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		9 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	INSERT / VAGINAL		69 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER, FOR SOLUTION / ORAL		315 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	PELLET / SUBCUTANEOUS	0.97 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	GRANULE / ORAL		1328 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	POWDER, FOR SOLUTION / ORAL		3767 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SOLUTION / TOPICAL	4 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SUSPENSION/ DROPS / OPHTHALMIC	3.3 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRATHECAL	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, POWDER, FOR SOLUTION / PARENTERAL	200 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	GRANULE / ORAL	5.4 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER, FOR SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	TABLET, COATED / ORAL	132 mg		Exact identifier — unii candidate 21 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
62013d8c-8993-4fe7-b65e-02b273673d86			d70e3165-18cc-424d-8a26-1c73986e147a	2017-08-30	Warnings	Exact identifier spl id: 62013d8c-8993-4fe7-b65e-02b273673d86 spl set id: d70e3165-18cc-424d-8a26-1c73986e147a

Reported adverse events (FAERS/openFDA)#

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