FDA.reportPublic FDA data

Childrens Pain and Fever

Manufacturer
WALGREENS CO.
Effective date
2025-11-25
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:18:11

Label at a glance#

ProductChildrens Pain and Fever Dissolve Packs
Active ingredientACETAMINOPHEN
Label structure10 sections

Indications and uses

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

Dosage and administration

this product does not contain directions or complete warnings for adult use. do not give more than directed (see overdose warning ) find right dose on chart. If possible, use weight to dose; otherwise, use age. tear packet and pour powder on your child's tongue repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours Weight (lb) Age (yrs.) Dose (packets)** under 48 under 6 years do n...

Storage and handling

store at room temperature TAMPER EVIDENT: DO NOT USE IF PACKET IS TORN OR DAMAGED

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each packet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 160 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if your child hasliver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if your child istaking the blood thinning drug warfarin

OTC - WHEN USING SECTION

When using this product do not exceed recommended dose (see overdose warning)

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning

SPL UNCLASSIFIED SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222).

Quick 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 (see overdose warning)
  • find right dose on chart. If possible, use weight to dose; otherwise, use age.
  • tear packet and pour powder on your child's tongue
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
Weight (lb)Age (yrs.)Dose (packets)**

under 48

under 6 years

do not use

48-59

6-8 years

2 packets

60-71

9-10 years

2 packets

72-95

11 years

  1. packets

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature

TAMPER EVIDENT: DO NOT USE IF PACKET IS TORN OR DAMAGED

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, flavor, gelatin, isomalt, silica, sucralose

Questions?

OTC - QUESTIONS SECTION

1-866-467-2748

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0363-5101-18

Children's

Dye-Free

Pain & Fever Dissolve Packs

ACETAMINOPHEN 160 mg
PAIN RELIEVER/FEVER REDUCER

DYE FREE, ASPIRIN FREE, IBUPROFEN FREE

  • No water needed
  • Dissolves in seconds

AGES 6-11 YEARS

18 PACKETS*
160 mg EACH PACKET

WILD BERRY FLAVOR

NATURALLY AND ARTIFICIALLY FLAVORED

*PACKETS OF POWDER

Pour powder on your child’s tongue

IMPORTANT:Keep this carton for future reference on full labeling.

Walgreens Pharmacist Recommended

Walgreens Pharmacist Survey

††This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of the registered trademark Children’s Tylenol® Dissolve Packs.

Distributed by:

WALGREEN CO.

200 WILMOT RD., CEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com © 2020 Walgreen Co.

Walgreens Dye-Free Pain and Fever Dissolve Packs
Walgreens Dye-Free Pain and Fever Dissolve Packs

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2178755acetaminophen 160 MG Oral PowderPSN7
2178755acetaminophen 160 MG Oral PowderSCD7
2178755APAP 160 MG Oral PowderSY7

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130311917215068GTIN-13: 0311917215068
EAN-13: 0311917215068
GTIN-12: 311917215068
UPC-A: 311917215068
GTIN storage (14 digits): 00311917215068		tylenol-01.jpg
Data codeITF01112756tylenol-01.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-5101-18Childrens Pain and FeverDissolve Packs1 in 1 PACKETPOWDER17
0363-5101-18Childrens Pain and FeverDissolve Packs18 in 1 CARTONPOWDER187

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-51010363-5101-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GELATIN, UNSPECIFIED2G86QN327LIACT
ISOMALTS870P55O2WIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SUCRALOSE96K6UQ3ZD4IACT
ACETAMINOPHEN362O9ITL9DACTIB

Source Document#

Source XML

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
Childrens Pain and Fever Dissolve PacksACETAMINOPHENWALGREENS CO.ea0f265f-7d64-4731-beda-0bb841dd1ad72025-11-25WarningsExact identifier
ndc (package): 0363-5101-18
ndc (product): 0363-5101
ndc11 (package): 00363510118
spl id: 446a2332-4899-48c7-e063-6294a90a291f
spl set id: ea0f265f-7d64-4731-beda-0bb841dd1ad7

Reported adverse events (FAERS/openFDA)#

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