Childrens Pain and Fever

Manufacturer: Walgreen Company | LNK International, Inc.
Effective date: 2018-01-25
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: legacy-cache
Hydrated at: 2026-08-02 01:04:05

Label at a glance#

ProductChildrens Pain and Fever Fast Dissolving

Active ingredientACETAMINOPHEN

Label structure9 sections

Indications and uses

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

Storage and handling

avoid high humidity 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#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-426-9391

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:
- headache
- the common cold
- flu
- toothache
- sore throat
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.
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

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

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 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 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

*or as directed by a doctor

Other information

STORAGE AND HANDLING SECTION

avoid high humidity
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, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, 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

Well at
Walgreens
WALGREENS PHARMACIST RECOMMENDED^ǂ

NDC 0363-0447-01

children's
FAST-DISSOLVING
Pain & Fever
Acetaminophen 80 mg /
Pain Reliever / Fever Reducer
• Aspirin free • Ibuprofen free
• Ages 2 to 6

30 FAST-DISSOLVING TABLETS

BUBBLEGUM FLAVOR

Compare to Children's Tylenol^® Meltaways^® active ingredient^ǂǂ

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

^ǂWalgreens Pharmacist Survey Study, November 2014.
^ǂǂThis product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Children's Tylenol^® Meltaways^®.
50844 REV0416A44701

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015

Walgreens 44-447

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0363-0447-01	EA - Each	0363-0447	152f0efb-59c6-44c2-b77e-7794205a75fd	1	2013-11-04

DailyMed Socrata Ingredients#

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

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

Childrens Pain and Fever Fast Dissolving
Acetaminophen
CITRIC ACID MONOHYDRATE
D&C RED NO. 27
D&C RED NO. 30
ETHYLCELLULOSE, UNSPECIFIED
MAGNESIUM STEARATE
MANNITOL
STEARIC ACID
SUCRALOSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0363-0447	0363-0447-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
ETHYLCELLULOSE, UNSPECIFIED	7Z8S9VYZ4B	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MANNITOL	3OWL53L36A	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 5 · 295 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
D&C RED NO. 27	D&C RED NO. 27	2LRS185U6K	TABLET / ORAL		1 mg	Exact identifier — unii candidate 4 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	LIQUID / ORAL		114 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / BUCCAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	52.5 mg		Exact identifier — unii candidate 14 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SYRUP / ORAL	722 mg/5ml		Exact identifier — unii candidate 88 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	LOZENGE / TRANSMUCOSAL		100 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	AEROSOL, FOAM / TOPICAL		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SOLUTION / ORAL		869 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SUSPENSION, EXTENDED RELEASE / ORAL		16 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	LOZENGE / ORAL		115 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SUSPENSION, EXTENDED RELEASE / ORAL	2464.6 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	POWDER / ORAL		2090 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	CAPSULE, EXTENDED RELEASE / ORAL		101 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, ORALLY DISINTEGRATING / ORAL		83 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	IMPLANT / SUBCUTANEOUS	6 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CAPSULE, EXTENDED RELEASE / ORAL		64 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SOLUTION/ DROPS / OPHTHALMIC	4.6 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET, FOR SUSPENSION / ORAL	2 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	SHAMPOO / TOPICAL	9.7 %w/w		Exact identifier — unii candidate 26 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
MANNITOL	MANNITOL	3OWL53L36A	GRANULE / ORAL		1328 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	CREAM / TOPICAL	NA		Exact identifier — unii candidate 14 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SPRAY / NASAL		9 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	SUSPENSION / ORAL	20 mg/5ml		Exact identifier — unii candidate 30 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOAP / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	CONCENTRATE / INTRAVENOUS		220 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
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRAMUSCULAR		28 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, SOLUTION / SUBCUTANEOUS		99 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
MANNITOL	MANNITOL	3OWL53L36A	WAFER / ORAL	642 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SOLUTION / ORAL		800 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	SUSPENSION/ DROPS / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SOLUTION / SUBCUTANEOUS	4.54 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, FILM COATED / ORAL		42 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	TABLET, COATED / ORAL	20 mg		Exact identifier — unii candidate 14 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC	4.35 %w/w		Exact identifier — unii candidate 65 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET / ORAL		45 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, FILM COATED / ORAL		2309 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CREAM / TOPICAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS		181 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION/ DROPS / ORAL		19 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	POWDER, FOR SUSPENSION / ORAL	1203 mg/5ml		Exact identifier — unii candidate 26 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	CAPSULE, EXTENDED RELEASE / ORAL		153 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TROCHE / ORAL	30 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	GRANULE, FOR SUSPENSION / ORAL		23 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
D&C RED NO. 27	D&C RED NO. 27	2LRS185U6K	TABLET, EXTENDED RELEASE / ORAL	1.43 mg		Exact identifier — unii candidate 4 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	FILM, SOLUBLE / ORAL		33 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
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SHAMPOO, SUSPENSION / TOPICAL	0.25 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / ORAL		25 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET, EXTENDED RELEASE / ORAL		101 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRAPLEURAL	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	SYSTEM / TOPICAL		10 mg	Exact identifier — unii candidate 14 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
f91b5bb2-95eb-484d-a00e-5dcff33b62bb			433c6efb-a94b-42ee-bd77-6b2739bf1ac0	2018-01-25	Warnings	Exact identifier spl id: f91b5bb2-95eb-484d-a00e-5dcff33b62bb spl set id: 433c6efb-a94b-42ee-bd77-6b2739bf1ac0

Reported adverse events (FAERS/openFDA)#

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