Major 44-452

Manufacturer
Major Pharmaceuticals | LNK International, Inc.
Effective date
2026-06-03
Label type
HUMAN OTC DRUG LABEL
Version
23
Source
daily-update
Hydrated at
2026-06-06 05:10:05

Label at a glance#

ProductChildrens Mapap
Active ingredientACETAMINOPHEN
Label structure9 sections

Indications and uses

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

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

Label contents#

Full prescribing information#

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

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 24Under 2Ask a doctor
24-352-32 tablets
36-474-53 tablets
48-596-84 tablets
60-719-105 tablets
72-95116 tablets

*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, 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

MAJOR®

NDC 0904-5791-46

Children's
Māpap®

acetaminophen 80 mg
chewable tablets

pain reliever/fever reducer

• aspirin free • ibuprofen free

chew or crush tablets completely before swallowing.

30 chewable tablets

ages 2-6

Actual Size

Chew or crush tablets completely before swallowing.

grape flavor

Major 44-452
Major 44-452

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130309045791462GTIN-13: 0309045791462
EAN-13: 0309045791462
GTIN-12: 309045791462
UPC-A: 309045791462
GTIN storage (14 digits): 00309045791462
major-44-452-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5791-46EA - Each0904-5791ccb7c15f-a886-4b5c-abd3-3a13255dcfd212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D5
ACETAMINOPHENACTIVE MOIETY362O9ITL9D5
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP5
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6K5
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808B5
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4B5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I305
MANNITOLINACTIVE INGREDIENT3OWL53L36A5
POVIDONESINACTIVE INGREDIENTFZ989GH94E5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP5
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD45

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
0904-57910904-5791-46

Ingredients#

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

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

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
222026-02-04full-release2026-06-01 01:46:26
212026-01-12monthly-update2026-06-03 17:52:41

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 2 · 84 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ETHYLCELLULOSESETHYLCELLULOSE7Z8S9VYZ4BTABLET, FILM COATED, EXTENDED RELEASE / ORAL52.5 mgExact identifier — unii+route
24 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, DELAYED RELEASE PELLETS / ORAL0.01 mgExact identifier — unii+route
44 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDFILM, SOLUBLE / ORAL0.04 mgExact identifier — unii+route
44 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / ORAL27.53 mgExact identifier — unii+route
44 equally ranked IID candidates
ETHYLCELLULOSESETHYLCELLULOSE7Z8S9VYZ4BTABLET, DELAYED RELEASE / ORAL53.8 mgExact identifier — unii+route
24 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii+route
44 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, CHEWABLE / ORAL7 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ETHYLCELLULOSESETHYLCELLULOSE7Z8S9VYZ4BPOWDER / ORAL2090 mgExact identifier — unii+route
24 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii+route
44 equally ranked IID candidates
ETHYLCELLULOSESETHYLCELLULOSE7Z8S9VYZ4BTABLET, EXTENDED RELEASE / ORAL1120 mgExact identifier — unii+route
24 equally ranked IID candidates
ETHYLCELLULOSESETHYLCELLULOSE7Z8S9VYZ4BGRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL1000 mgExact identifier — unii+route
24 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCONCENTRATE / ORALNAExact identifier — unii+route
44 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii+route
44 equally ranked IID candidates
ETHYLCELLULOSESETHYLCELLULOSE7Z8S9VYZ4BCAPSULE, EXTENDED RELEASE / ORAL153 mgExact identifier — unii+route
24 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, CHEWABLE / ORAL180 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ETHYLCELLULOSESETHYLCELLULOSE7Z8S9VYZ4BTABLET, DELAYED RELEASE / ORAL53.8 mgExact identifier — unii+route
24 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, FILM COATED / ORAL0.16 mgExact identifier — unii+route
44 equally ranked IID candidates
ETHYLCELLULOSESETHYLCELLULOSE7Z8S9VYZ4BTABLET, EXTENDED RELEASE / ORAL1120 mgExact identifier — unii+route
24 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE / ORAL26.3 mgExact identifier — unii+route
44 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, CHEWABLE / ORAL48 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, DELAYED RELEASE PELLETS / ORAL0.01 mgExact identifier — unii+route
44 equally ranked IID candidates
D&C RED NO. 27D&C RED NO. 272LRS185U6KTABLET, CHEWABLE / ORAL7 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ETHYLCELLULOSESETHYLCELLULOSE7Z8S9VYZ4BSUSPENSION, EXTENDED RELEASE / ORALNAExact identifier — unii+route
24 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, COATED PELLETS / ORALNAExact identifier — unii+route
44 equally ranked IID candidates
D&C RED NO. 27D&C RED NO. 272LRS185U6KTABLET, CHEWABLE / ORAL7 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, CHEWABLE / ORAL180 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
D&C RED NO. 30D&C RED NO. 302S42T2808BTABLET, CHEWABLE / ORAL3 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSUSPENSION / ORAL1 mgExact identifier — unii+route
44 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, SUGAR COATED / ORALNAExact identifier — unii+route
44 equally ranked IID candidates
ETHYLCELLULOSESETHYLCELLULOSE7Z8S9VYZ4BGRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL1000 mgExact identifier — unii+route
24 equally ranked IID candidates
ETHYLCELLULOSESETHYLCELLULOSE7Z8S9VYZ4BPOWDER, FOR SUSPENSION / ORALNAExact identifier — unii+route
24 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / ORAL27.53 mgExact identifier — unii+route
44 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDLIQUID / ORALNAExact identifier — unii+route
44 equally ranked IID candidates
ETHYLCELLULOSESETHYLCELLULOSE7Z8S9VYZ4BCAPSULE / ORAL12.32 mgExact identifier — unii+route
24 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, LIQUID FILLED / ORAL0.08 mgExact identifier — unii+route
44 equally ranked IID candidates
ETHYLCELLULOSESETHYLCELLULOSE7Z8S9VYZ4BTABLET, COATED / ORAL20 mgExact identifier — unii+route
24 equally ranked IID candidates
ETHYLCELLULOSESETHYLCELLULOSE7Z8S9VYZ4BTABLET / ORAL300 mgExact identifier — unii+route
24 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, LIQUID FILLED / ORAL0.08 mgExact identifier — unii+route
44 equally ranked IID candidates
ETHYLCELLULOSESETHYLCELLULOSE7Z8S9VYZ4BTABLET, COATED / ORAL20 mgExact identifier — unii+route
24 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSUSPENSION / ORAL1 mgExact identifier — unii+route
44 equally ranked IID candidates
D&C RED NO. 30D&C RED NO. 302S42T2808BTABLET, CHEWABLE / ORAL3 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, CHEWABLE / ORAL48 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, SUGAR COATED / ORALNAExact identifier — unii+route
44 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, CHEWABLE / ORAL7 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, CHEWABLE / ORAL3726 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ETHYLCELLULOSESETHYLCELLULOSE7Z8S9VYZ4BPOWDER / ORAL2090 mgExact identifier — unii+route
24 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDELIXIR / ORALNAExact identifier — unii+route
44 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, DELAYED RELEASE / ORAL2 mgExact identifier — unii+route
44 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPOWDER, FOR SOLUTION / ORAL0.04 mg/5mlExact identifier — unii+route
44 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSYRUP / ORAL0.05 mg/5mlExact identifier — unii+route
44 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDFILM, SOLUBLE / ORAL0.04 mgExact identifier — unii+route
44 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPOWDER, FOR SUSPENSION / ORAL1 mg/5mlExact identifier — unii+route
44 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii+route
44 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDELIXIR / ORALNAExact identifier — unii+route
44 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, CHEWABLE / ORAL28 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ETHYLCELLULOSESETHYLCELLULOSE7Z8S9VYZ4BCAPSULE, EXTENDED RELEASE / ORAL153 mgExact identifier — unii+route
24 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, CHEWABLE / ORAL28 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPOWDER, FOR SUSPENSION / ORAL1 mg/5mlExact identifier — unii+route
44 equally ranked IID candidates
ETHYLCELLULOSESETHYLCELLULOSE7Z8S9VYZ4BPOWDER, FOR SUSPENSION / ORALNAExact identifier — unii+route
24 equally ranked IID candidates
ETHYLCELLULOSESETHYLCELLULOSE7Z8S9VYZ4BCAPSULE / ORAL12.32 mgExact identifier — unii+route
24 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
Childrens MapapACETAMINOPHENMajor Pharmaceuticalsefec6af2-8b26-47f6-88c8-b0a6d69a2d7d2026-06-03WarningsExact identifier
ndc (package): 0904-5791-46
ndc (product): 0904-5791
ndc11 (package): 00904579146
spl id: 2bd5ccbd-a062-4af1-bc34-99498594c2ba
spl set id: efec6af2-8b26-47f6-88c8-b0a6d69a2d7d

Reported adverse events (FAERS/openFDA)#

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