Pain and Fever

Manufacturer
Walgreen Company | LNK International, Inc.
Effective date
2018-08-14
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-02 00:52:51

Label at a glance#

ProductPain and Fever Junior
Active ingredientACETAMINOPHEN
Label structure9 sections

Indications and uses

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

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient (in each 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
    • toothache
    • the common cold
    • sore throat
    • flu
  • 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

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) Under 48 48-5960-71  72-95
 Age (yr)  Under 6 6-8 9-10 11
 Dose (tablets)*  Ask a doctor 2 2 1/2 3

* 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
  • 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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

 1-800-426-9391

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Well at
Walgreens
WALGREENS PHARMACIST RECOMMENDEDǂ

NDC 0363-4500-08

Junior
FAST-DISSOLVING

PAIN & FAVOR

Acetaminophen 160 mg / Pain Reliever /
Fever Reducer

• Aspirin free • Ibuprofen free
• Ages 6 to 11

24 FAST-DISSOLVING TABLETS

BUBBLEGUM FLAVOR

Compare to Jr. Strength Tylenol® Meltaways® active ingredientǂǂ 

ǂWalgreens Pharmacist Survey Study, November 2014.

50844       REV0416D45008
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com     ©2016 Walgreen Co.

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

ǂǂThis product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Jr. Strength Tylenol® Meltaways®.Walgreens 44-450Walgreens 44-450

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130311917086040GTIN-13: 0311917086040
EAN-13: 0311917086040
GTIN-12: 311917086040
UPC-A: 311917086040
GTIN storage (14 digits): 00311917086040
walgreens-44-450-delisted-1.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-4500-08EA - Each0363-45001ed3f2a4-3250-4c9b-a513-9dd66d96bbb312022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D1
ACETAMINOPHENACTIVE MOIETY362O9ITL9D1
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6K1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808B1
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4B1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
MANNITOLINACTIVE INGREDIENT3OWL53L36A1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD41

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-45000363-4500-08

Ingredients#

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

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

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 3 · 177 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MANNITOLMANNITOL3OWL53L36ATABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL1568 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, CHEWABLE / ORAL3726 mgExact identifier — unii candidate
65 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, EXTENDED RELEASE / ORAL200 mgExact identifier — unii candidate
26 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30SYSTEM / INTRAVITREAL0.02 mgExact identifier — unii candidate
39 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4GUM, CHEWING / BUCCAL70 mgExact identifier — unii candidate
22 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii candidate
26 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, DELAYED RELEASE / ORAL1060 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30RING / VAGINAL2 mgExact identifier — unii candidate
39 equally ranked IID candidates
D&C RED NO. 30D&C RED NO. 302S42T2808BTABLET / ORAL19 mgExact identifier — unii candidate
7 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER / ORAL25 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30SUSPENSION, EXTENDED RELEASE / ORAL71 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER / RESPIRATORY (INHALATION)0.13 mgExact identifier — unii candidate
39 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASOLUTION / INTRAVENOUS15400 mgExact identifier — unii candidate
65 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30PELLET / ORAL24 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, DELAYED RELEASE / ORAL144 mgExact identifier — unii candidate
39 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, ORALLY DISINTEGRATING / ORAL60 mgExact identifier — unii candidate
22 equally ranked IID candidates
D&C RED NO. 27D&C RED NO. 272LRS185U6KTABLET, EXTENDED RELEASE / ORAL1.43 mgExact identifier — unii candidate
4 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION / SUBCUTANEOUS675 mgExact identifier — unii candidate
65 equally ranked IID candidates
ETHYLCELLULOSESETHYLCELLULOSE7Z8S9VYZ4BPOWDER / ORAL2090 mgExact identifier — unii candidate
14 equally ranked IID candidates
ETHYLCELLULOSESETHYLCELLULOSE7Z8S9VYZ4BTABLET / ORAL300 mgExact identifier — unii candidate
14 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS980.4 mgExact identifier — unii candidate
65 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CREAM / TOPICALNAExact identifier — unii candidate
39 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4GRANULE, FOR SUSPENSION / ORAL23 mgExact identifier — unii candidate
22 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, DELAYED RELEASE / ORAL80 mgExact identifier — unii candidate
26 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASUSPENSION/ DROPS / TOPICAL0.3 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
ETHYLCELLULOSESETHYLCELLULOSE7Z8S9VYZ4BPOWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
14 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE / ORAL256.4 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30GRANULE, FOR SUSPENSION / ORAL14 mgExact identifier — unii candidate
39 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, SOLUTION / SUBMUCOSAL2.94 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, CHEWABLE / ORAL28 mgExact identifier — unii candidate
22 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36APOWDER, FOR SUSPENSION / ORAL7093 mgExact identifier — unii candidate
65 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4GRANULE / ORAL5.4 mgExact identifier — unii candidate
22 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30DROPS / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
D&C RED NO. 30D&C RED NO. 302S42T2808BTABLET, EXTENDED RELEASE / ORAL0.22 mgExact identifier — unii candidate
7 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED, EXTENDED RELEASE / ORAL120 mgExact identifier — unii candidate
26 equally ranked IID candidates
D&C RED NO. 30D&C RED NO. 302S42T2808BTABLET, CHEWABLE / ORAL3 mgExact identifier — unii candidate
7 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ACAPSULE, COATED PELLETS / ORAL14 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASOLUTION / OPHTHALMIC4.7 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, FILM COATED / ORAL2309 mgExact identifier — unii candidate
65 equally ranked IID candidates
ETHYLCELLULOSESETHYLCELLULOSE7Z8S9VYZ4BSYSTEM / TOPICAL10 mgExact identifier — unii candidate
14 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET / ORAL3391 mgExact identifier — unii candidate
65 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TROCHE / ORAL315 mgExact identifier — unii candidate
39 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APAEROSOL, FOAM / TOPICAL8 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASUSPENSION, EXTENDED RELEASE / ORAL2464.6 mgExact identifier — unii candidate
65 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30INHALANT / ORAL0.08 mgExact identifier — unii candidate
39 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SUSPENSION, EXTENDED RELEASE / ORAL16 mgExact identifier — unii candidate
22 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36APOWDER, FOR SUSPENSION / INTRAMUSCULAR6.75 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR105 mgExact identifier — unii candidate
65 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4FILM, SOLUBLE / ORAL33 mgExact identifier — unii candidate
22 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, ORALLY DISINTEGRATING / ORAL4364 mgExact identifier — unii candidate
65 equally ranked IID candidates
ETHYLCELLULOSESETHYLCELLULOSE7Z8S9VYZ4BGRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL1000 mgExact identifier — unii candidate
14 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, ORALLY DISINTEGRATING / ORAL10 mgExact identifier — unii candidate
26 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
D&C RED NO. 30D&C RED NO. 302S42T2808BCAPSULE / ORAL0.1 mgExact identifier — unii candidate
7 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASOLUTION / ORAL869 mgExact identifier — unii candidate
65 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TROCHE / ORAL60 mgExact identifier — unii candidate
22 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30INSERT / VAGINAL69 mgExact identifier — unii candidate
39 equally ranked IID candidates
D&C RED NO. 27D&C RED NO. 272LRS185U6KTABLET, CHEWABLE / ORAL7 mgExact identifier — unii candidate
4 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASOLUTION/ DROPS / OPHTHALMIC4.6 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, EFFERVESCENT / ORAL1080 mgExact identifier — unii candidate
22 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ced8743d-a5e6-4513-a075-426b4692428d4ff027d1-ba7e-4ada-ac85-e99db6de2a912018-08-14WarningsExact identifier
spl id: ced8743d-a5e6-4513-a075-426b4692428d
spl set id: 4ff027d1-ba7e-4ada-ac85-e99db6de2a91

Reported adverse events (FAERS/openFDA)#

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