FDA.reportPublic FDA data

Childrens Acetaminophen

Manufacturer
Major Pharmaceuticals
Effective date
2025-01-24
Label type
HUMAN OTC DRUG LABEL
Version
16
Source
full-release
Hydrated at
2026-06-01 00:53:34

Label at a glance#

ProductChildrens Acetaminophen
Active ingredientACETAMINOPHEN
Label structure10 sections

Indications and uses

temporarily: reduces fever relieves minor aches and pain 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 take more than directed (see overdose warning) shake well before using mL = milliliter find the right dose on chart below. If possible, use weight to dose; otherwise, use age repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours Weight (lb) Age (yr ) Dose (mL) * Under 24 Under 2 Ask a doctor 24-35 2...

Storage and handling

each 5 mL contains : sodium 2 mg Store at 20° to 25°C (68° to 77°F) a red, strawberry flavored suspension supplied in the following oral dosage form: NDC 0904-7278-41:  5 mL unit dose cup, in a tray of ten cups

Label contents#

Full prescribing information#

Active ingredient                                                                                 (in each 5 mL)  

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 160 mg.........................................Pain reliever/fever reducer

Uses

OTC - PURPOSE SECTION

temporarily:

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

Warnings

WARNINGS SECTION

Liver warning: This product contains 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

INDICATIONS & USAGE 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 liver disease.

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.

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

Stop use and ask a doctor if:
• 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 the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

 Overdose warning: 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 children even if you do not notice any sign or symptoms

Directions

DOSAGE & ADMINISTRATION SECTION

  • this product does not contain directions or complete warnings for adult use
  • do not take more than directed (see overdose warning)
  • shake well before using
  • mL = milliliter
  • find the right dose on chart below. If possible, use weight to dose; otherwise, use age
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
Weight (lb)Age (yr)Dose (mL) *
Under 24Under 2Ask a doctor
24-352-3 years5 mL 
36-474-5 years7.5 mL 
48-596-8 years10 mL 
60-719-10 years12.5 mL 
72-9511 years15 mL 

*or as directed by a doctor

Other information

STORAGE AND HANDLING SECTION

  • each 5 mL contains: sodium 2 mg
  • Store at 20° to 25°C (68° to 77°F)
  • a red, strawberry flavored suspension supplied in the following oral dosage form:
    NDC 0904-7278-41:  5 mL unit dose cup, in a tray of ten cups

Inactive ingredients:

INACTIVE INGREDIENT SECTION

acesulfame K, butylparaben, citric acid, FD&C Red No. 40, flavoring, glycerin, high fructose corn syrup, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, veegum and xanthan gum.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-845-8210.

SPL UNCLASSIFIED SECTION

R08/22

Distributed by:

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268


PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAJOR®

0904-7278-41

Children's Acetaminophen Oral Suspension

160 mg per 5 mL

Pain Reliever • Fever Reducer

Ibuprofen Free/ Alcohol Free / Aspirin Free

SHAKE WELL

Delivers 5 mL • See insert

For Institutional Use Only

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

F1781C050822

Children's Acetaminophen Oral Suspension - UD CupChildren's Acetaminophen Oral Suspension - UD Cup

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN16
307668acetaminophen 32 MG/ML Oral SuspensionSCD16
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY16
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY16
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY16
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY16
307668APAP 32 MG/ML Oral SuspensionSY16

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
0904-7278-41Childrens Acetaminophen5 mL in 1 CUP, UNIT-DOSESUSPENSION516
0904-7278-70Childrens Acetaminophen10 in 1 TRAYSUSPENSION1016
0904-7278-70Childrens Acetaminophen10 in 1 CASESUSPENSION1016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7278CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [MAJOR PHARMACEUTICALS]16Current NDC, 3 package rows20250125_38b839b6-de7d-4f33-a19a-efc92cdad92c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7278-41ML - Milliliter0904-7278ee8d4d33-749f-4778-9a52-9045f053995e12023-08-08
0904-7278-70ML - Milliliter0904-727877a3f337-8302-4db0-806a-3d46fbd88aaa12023-08-08
0121-1781-00ML - Milliliter0121-1781216b7a39-3839-44f8-ba3a-cf40c805602912017-06-15
0121-1781-05ML - Milliliter0121-17819246f12e-a346-4cc7-95b3-f112f0c7685112015-02-02

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0904-72780904-7278-41, 0904-7278-70
0121-1781

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
ACESULFAME POTASSIUM23OV73Q5G9IACT
BUTYLPARABEN3QPI1U3FV8IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL SOLUTION8KW3E207O2IACT
XANTHAN GUMTTV12P4NEEIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens AcetaminophenACETAMINOPHENMajor Pharmaceuticals38b839b6-de7d-4f33-a19a-efc92cdad92c2025-01-24WarningsExact identifier
ndc (package): 0904-7278-41
ndc (package): 0904-7278-70
ndc (product): 0904-7278
ndc11 (package): 00904727870
ndc11 (package): 00904727841
spl id: 574dcd8d-5656-4748-bc1e-7331fe2b8b44
spl set id: 38b839b6-de7d-4f33-a19a-efc92cdad92c
Childrens AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharma46d9d8cd-e3db-492c-9386-7e8255beff642024-10-08WarningsExact identifier
ndc (product): 0121-1781

Reported adverse events (FAERS/openFDA)#

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