FDA.reportPublic FDA data

Walgreens 44-449 Childrens

Manufacturer
Walgreen Company | LNK International, Inc.
Effective date
2026-04-16
Label type
HUMAN OTC DRUG LABEL
Version
15
Source
full-release
Hydrated at
2026-06-01 01:53:49

Label at a glance#

ProductPain and Fever Childrens
Active ingredientACETAMINOPHEN
Label structure9 sections

Indications and uses

temporarily relieves minor aches and pains due to: headache sore throat flu toothache the common cold 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 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 Weight (lb) Age (yr) Dose (chewable tablets)* Under ...

Storage and handling

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN avoid high humidity store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number

Label contents#

Full prescribing information#

Active ingredient (in each chewable tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 160 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

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

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.

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
  • redness or swelling is present
  • any new symptoms appear

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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 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
Weight (lb)Age (yr)
Dose (chewable tablets)*
Under 24
Under 2
Ask a doctor
24-35
2-3
1 tablet
36-47
4-5
1 1/2 tablets
48-59
6-8
2 tablets
60-71
9-10
2 1/2 tablets
72-95
11
3 tablets

*or as directed by a doctor

Other information

STORAGE AND HANDLING SECTION

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • avoid high humidity
  • store at 25°C (77°F); 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, FD&C blue #1 aluminum lake, 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

Walgreens

Compare to the active ingredient
in Children’s Tylenol® Chewables††

• WALGREENS •
PHARMACIST RECOMMENDED†

Children’s
Pain & Fever

ACETAMINOPHEN 160 mg CHEWABLE TABLETS
PAIN RELIEVER / FEVER REDUCER

Chewable
Aspirin Free
Ibuprofen Free

AGES
2-11
YEARS

24 CHEWABLE TABLETS

ACTUAL SIZE

Grape flavor
(160 mg each)

Chew or crush tablets completely before
swallowing. Do not swallow tablets whole.

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED
OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY
SIGNS OF TAMPERING   

†Our pharmacists recommend the Walgreens brand. We invite you to
compare to national brands.
††This product is not manufactured or distributed by Kenvue Inc.,
owner of the registered trademark Tylenol®.

50844   REV0424B44908

NDC 0363-9440-08

ITEM 980502

DISTRIBUTED BY: WALGREEN CO.
DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com
©2026 Walgreen Co.

Walgreens 44-449
Walgreens 44-449

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313820acetaminophen 160 MG Chewable TabletPSN15
313820acetaminophen 160 MG Chewable TabletSCD15
313820APAP 160 MG Chewable TabletSY15

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130311917190754GTIN-13: 0311917190754
EAN-13: 0311917190754
GTIN-12: 311917190754
UPC-A: 311917190754
GTIN storage (14 digits): 00311917190754		walgreens-44-449-childrens-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-9440-08Pain and FeverChildrens4 in 1 CARTONTABLET, CHEWABLE415
0363-9440-08Pain and FeverChildrens6 in 1 BLISTER PACKTABLET, CHEWABLE615

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-9440-08EA - Each0363-944066e56acf-17ec-4129-b160-d933d5f7fabe12022-06-06

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-94400363-9440-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CROSPOVIDONE, UNSPECIFIED2S7830E561IACT
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
D&C RED NO. 30 ALUMINUM LAKEGE75M6YV5WIACT
DEXTROSE MONOHYDRATELX22YL083GIACT
ETHYLCELLULOSE, UNSPECIFIED7Z8S9VYZ4BIACT
FD&C BLUE NO. 1 ALUMINUM LAKEJ9EQA3S2JMIACT
MAGNESIUM STEARATE70097M6I30IACT
MANNITOL3OWL53L36AIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
STEARIC ACID4ELV7Z65APIACT
SUCRALOSE96K6UQ3ZD4IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
142026-01-27monthly-update2026-06-03 17:53:16

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain and Fever ChildrensACETAMINOPHENWalgreen Company1f3e2895-5ef7-4e6a-8d2e-b805d148f9802026-04-16WarningsExact identifier
ndc (package): 0363-9440-08
ndc (product): 0363-9440
ndc11 (package): 00363944008
spl id: 14049720-9a58-4dac-aad4-70d14a4c2280
spl set id: 1f3e2895-5ef7-4e6a-8d2e-b805d148f980

Reported adverse events (FAERS/openFDA)#

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