Childrens Acetaminophen

Manufacturer
Wal-Mart Stores Inc | LNK International, Inc.
Effective date
2017-09-19
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 01:11:58

Label at a glance#

ProductChildrens Acetaminophen
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 warning for adult use find the right dose on chart. If possible, use weight to dose; otherwise, use age. dissolve in mouth or chew before swallowing 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

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 (1-800-222-1222) 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 warning for adult use
  • find the right dose on chart. If possible, use weight to dose; otherwise, use age.
  • dissolve in mouth or chew before swallowing
  • 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?

OTC - QUESTIONS SECTION

1-888-287-1915

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

equate®

NDC 49035-447-01

Compare to Children's Tylenol® Meltaways® Active Ingredient*

Ages 2-6
Children's
Acetaminophen
Fever Reducer/Pain Reliever

Aspirin Free
Ibuprofen Free

Bubble Gum Flavor

80 mg EACH

30 RAPID TABS

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

Distributed by:
Wal-Mart Stores, Inc.
Bentonville, AR 72716

© Wal-Mart Stores, Inc.

*This product is not manufactured or
distributed by McNeil Consumer Healthcare,
owner of the registered trademark Children’s
Tylenol® Meltaways®.

50844      REV0412E44701

Equate 44-447
Equate 44-447

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130681131837422GTIN-13: 0681131837422
EAN-13: 0681131837422
GTIN-12: 681131837422
UPC-A: 681131837422
GTIN storage (14 digits): 00681131837422
equate-44-447-1.jpg
Data codeCode 12850014601equate-44-447-1.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-447-01EA - Each49035-44704690685-5ffe-4a0d-bf73-2b8ca432033a12015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D2
ACETAMINOPHENACTIVE MOIETY362O9ITL9D2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP2
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6K2
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808B2
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4B2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I302
MANNITOLINACTIVE INGREDIENT3OWL53L36A2
POVIDONESINACTIVE INGREDIENTFZ989GH94E2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD42

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49035-44749035-447-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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 5 · 295 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRALESIONALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94EINJECTION / INTRAMUSCULAR0.2 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ECAPSULE / ORAL300 mgExact identifier — unii candidate
30 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, EXTENDED RELEASE / ORAL173 mgExact identifier — unii candidate
39 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS15400 mgExact identifier — unii candidate
65 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94EDROPS / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, DELAYED RELEASE / ORAL53 mgExact identifier — unii candidate
30 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPFILM, EXTENDED RELEASE / TRANSDERMAL1.38 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLOTION / TOPICAL0.85 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4GRANULE, FOR SUSPENSION / ORAL23 mgExact identifier — unii candidate
22 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET / ORAL3391 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET / BUCCAL360 mgExact identifier — unii candidate
65 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APAEROSOL, FOAM / TOPICAL8 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
ETHYLCELLULOSESETHYLCELLULOSE7Z8S9VYZ4BPOWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
14 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APLOTION / TOPICAL80 mgExact identifier — unii candidate
26 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / INTRAMUSCULAR0.05 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / BUCCAL17.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APEMULSION / TOPICALNAExact identifier — unii candidate
26 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, FILM COATED, EXTENDED RELEASE / ORAL17 mgExact identifier — unii candidate
30 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ACONCENTRATE / INTRAVENOUS220 mgExact identifier — unii candidate
65 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / INTRAMUSCULAR26 mgExact identifier — unii candidate
88 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
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / ORAL446 mgExact identifier — unii candidate
88 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET / SUBLINGUAL12 mgExact identifier — unii candidate
22 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL1568 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AGUM, CHEWING / BUCCAL891 mgExact identifier — unii candidate
65 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / RESPIRATORY (INHALATION)0.13 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SUSPENSION / ORAL383 mgExact identifier — unii candidate
22 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AGRANULE, FOR SUSPENSION / ORAL6000 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS181 mgExact identifier — unii candidate
65 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET / SUBLINGUAL6 mgExact identifier — unii candidate
30 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ACAPSULE, DELAYED RELEASE / ORAL2043 mgExact identifier — unii candidate
65 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30IMPLANT / INTRAVITREALNAExact identifier — unii candidate
39 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APAEROSOL, FOAM / VAGINAL4 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPDROPS / ORALNAExact identifier — unii candidate
88 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SYRUP / ORAL80 mgExact identifier — unii candidate
22 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APPELLET / SUBCUTANEOUS0.97 mgExact identifier — unii candidate
26 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
SUCRALOSESUCRALOSE96K6UQ3ZD4SPRAY / NASAL2 mgExact identifier — unii candidate
22 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36APOWDER, FOR SOLUTION / ORAL3767 mgExact identifier — unii candidate
65 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, ORALLY DISINTEGRATING / ORAL15.03 mgExact identifier — unii candidate
30 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ACAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36APOWDER, FOR SUSPENSION / INTRAMUSCULAR6.75 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPAEROSOL, FOAM / RECTAL7 mgExact identifier — unii candidate
88 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, COATED / ORAL49.2 mgExact identifier — unii candidate
30 equally ranked IID candidates
ETHYLCELLULOSESETHYLCELLULOSE7Z8S9VYZ4BCAPSULE, EXTENDED RELEASE / ORAL153 mgExact identifier — unii candidate
14 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30LOZENGE / ORAL420 mgExact identifier — unii candidate
39 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION/ DROPS / TOPICAL0.01 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETROCHE / ORAL30 mgExact identifier — unii candidate
30 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30SUSPENSION, EXTENDED RELEASE / ORAL71 mgExact identifier — unii candidate
39 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION/ DROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPAEROSOL, FOAM / TOPICAL1 mgExact identifier — unii candidate
88 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASUSPENSION/ DROPS / OPHTHALMIC3.3 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR113 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AGRANULE / ORAL1328 mgExact identifier — unii candidate
65 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSHAMPOO / TOPICAL17 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION, CONCENTRATE / IRRIGATION1 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRAPLEURALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SPRAY, METERED / NASAL2 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
56bfe266-f9ff-483c-b360-ecac1d21fdb130d02c61-db29-4399-bf50-b913346d5e3c2017-09-19WarningsExact identifier
spl id: 56bfe266-f9ff-483c-b360-ecac1d21fdb1
spl set id: 30d02c61-db29-4399-bf50-b913346d5e3c

Reported adverse events (FAERS/openFDA)#

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