FDA.reportPublic FDA data

Acetaminophen Oral Solution USP - Major

Manufacturer
Major Pharmaceuticals
Effective date
2025-01-09
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
full-release
Hydrated at
2026-06-01 00:53:34

Label at a glance#

ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure12 sections

Indications and uses

temporarily relieves minor aches and pains due to:  headache  muscular aches  backache  minor pain of arthritis  the common cold  toothache  premenstrual and menstrual cramps temporarily reduces fever

Dosage and administration

  do not take more than directed (see overdose warning) age dose adults and children 12 years of age and over 20.3 mL (650 mg) every 4 to 6 hours not to exceed 6 doses in a 24-hour period children 6 to under 12 years of age 10.15 mL (325 mg) every 4 hours not to exceed 5 doses in a 24-hour period children 4 to under 6 years of age 7.5 mL (240 mg) every 4 hours not to exceed 5 doses in a 24-hour period children 2 t...

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

(in each 5 mL teaspoonful)

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

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains due to:

  •  headache
  •  muscular aches
  •  backache
  •  minor pain of arthritis
  •  the common cold
  •  toothache
  •  premenstrual and menstrual cramps

temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warning:  This product contains acetaminophen. Severe liver damage may occur if:

  •  adult takes more than 6 doses in 24 hours, which is the maximum daily amount
  • child takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product

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.
  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor

  • if you are allergic to acetaminophen or any of the inactive ingredients of this product

Ask a doctor before use if the user has  liver disease

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • symptoms do not improve
  • new symptoms occur
  • pain or fever persists or gets worse

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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 right away.  (1-800-222-1222). Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  •  do not take more than directed (see overdose warning)

age

dose

adults and children 12 years of age and over

20.3 mL (650 mg) every 4 to 6 hours

not to exceed 6 doses in a 24-hour period

children 6 to under 12 years of age

10.15 mL (325 mg) every 4 hours

not to exceed 5 doses in a 24-hour period

children 4 to under 6 years of age

7.5 mL (240 mg) every 4 hours

not to exceed 5 doses in a 24-hour period

children 2 to under 4 years of age

5 mL (160 mg) every 4 hours

not to exceed 5 doses in a 24-hour period

children under 2 years of age

consult a doctor


Other information

SPL UNCLASSIFIED SECTION

  •  Each 5 mL contains:  sodium 2 mg
  •  store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]
  •  keep tightly closed  ■ protect from light
  •  a red, cherry flavored solution supplied in the following oral dosage forms:

NDC 0904-7319-41: 5 mL unit dose cup, in a tray of ten cups.

NDC 0904-7320-02: 10.15 mL unit dose cup, in a tray of ten cups.

NDC 0904-7321-03: 20.3 mL unit dose cup, in a tray of ten cups.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric acid, FD&C Red No. 40, flavoring, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol and sucrose.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-845-8210. You may also report serious side effects to this phone number.

R11/22

Distributed by:

SPL UNCLASSIFIED SECTION

MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268

PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAJOR®

NDC 0904-7319-41

Acetaminophen Oral Solution USP

160 mg/ 5 mL

ALCOHOL FREE

Delivers 5 mL  • See insert

For Institutional Use Only

MAJOR®PHARMACEUTICALS
Indianapolis, IN 46268

F0657C051022

5 mL unit dose cup
5 mL unit dose cup

PRINCIPAL DISPLAY PANEL - 10.15 mL Unit Dose Cup

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAJOR®

NDC 0904-7320-02

Acetaminophen Oral Solution USP

325 mg/ 10.15 mL

Alcohol Free

Delivers 10.15 mL  • See insert

For Institutional Use Only

MAJOR®PHARMACEUTICALS
Indianapolis, IN 46268

F0657C111022

10.15 mL unit dose cup
10.15 mL unit dose cup

PRINCIPAL DISPLAY PANEL - 20.3 mL Unit Dose Cup

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAJOR®

NDC 0904-7321-03

Acetaminophen Oral Solution USP

650 mg/ 20.3 mL

Alcohol Free

Delivers 20.3 mL  • See insert

For Institutional Use Only

MAJOR®PHARMACEUTICALS
Indianapolis, IN 46268

F0657C211022

20.3 mL unit dose cup
20.3 mL unit dose cup

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307675acetaminophen 160 MG in 5 mL Oral SolutionPSN14
307675acetaminophen 32 MG/ML Oral SolutionSCD14
307675acetaminophen 160 MG per 5 ML Oral SolutionSY14
307675acetaminophen 325 MG per 10.15 ML Oral SolutionSY14
307675acetaminophen 650 MG per 20.3 ML Oral SolutionSY14
307675acetaminophen 80 MG per 2.5 ML Oral SolutionSY14
307675APAP 32 MG/ML Oral SolutionSY14

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-7319-41Acetaminophen5 mL in 1 CUP, UNIT-DOSESOLUTION514
0904-7319-70Acetaminophen10 in 1 CASESOLUTION1014
0904-7319-70Acetaminophen10 in 1 TRAYSOLUTION1014
0904-7320-02Acetaminophen10.15 mL in 1 CUP, UNIT-DOSESOLUTION10.1514
0904-7320-71Acetaminophen10 in 1 CASESOLUTION1014
0904-7320-71Acetaminophen10 in 1 TRAYSOLUTION1014
0904-7321-03Acetaminophen20.3 mL in 1 CUP, UNIT-DOSESOLUTION20.314
0904-7321-76Acetaminophen10 in 1 TRAYSOLUTION1014
0904-7321-76Acetaminophen10 in 1 CASESOLUTION1014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7319ACETAMINOPHEN SOLUTION [MAJOR PHARMACEUTICALS]14Current NDC, 3 package rows20250125_32ea1230-f9ae-46b0-910e-05cd187cee34.zip
0904-7320ACETAMINOPHEN SOLUTION [MAJOR PHARMACEUTICALS]14Current NDC, 3 package rows20250125_32ea1230-f9ae-46b0-910e-05cd187cee34.zip
0904-7321ACETAMINOPHEN SOLUTION [MAJOR PHARMACEUTICALS]14Current NDC, 3 package rows20250125_32ea1230-f9ae-46b0-910e-05cd187cee34.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7319-41ML - Milliliter0904-7319b338b022-da99-4763-aef8-7a9dc235a3ba12023-07-06
0904-7319-70ML - Milliliter0904-73194f976a39-bdf5-4d4e-b9c8-bbcc9b89df8312023-07-06
0121-0657-00ML - Milliliter0121-0657e1717ddd-2220-4c37-bf4c-358cc59233d512017-03-06
0121-0657-05ML - Milliliter0121-06578ed88d7b-7da9-4476-8acb-44b7546ea72912013-02-13
0121-0657-11ML - Milliliter0121-0657a7c14538-cd3f-460a-9934-c44d6cfa1d5612013-02-13
0121-0657-21ML - Milliliter0121-0657da514a8a-21cf-4316-988f-d31df443bed612013-02-13
0904-7320-02ML - Milliliter0904-7320e0688088-2fc3-4aef-a76a-7dd62aa86f9c12023-07-06
0904-7320-71ML - Milliliter0904-7320b9a0473f-3082-463b-9e3d-0185bfdbd4d512023-07-06
0904-7321-03ML - Milliliter0904-7321f2e2ac24-0e1f-452c-89a8-9f1bbc345cbd12023-07-06
0904-7321-76ML - Milliliter0904-7321f5e91536-6484-43ff-9a65-dea899f75cca12023-07-06

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
0904-73190904-7319-41, 0904-7319-70
0121-0657
0904-73200904-7320-02, 0904-7320-71
0904-73210904-7321-03, 0904-7321-76

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
SUCROSEC151H8M554IACT
ACETAMINOPHEN362O9ITL9DACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
SUCROSEC151H8M554IACT
ACETAMINOPHEN362O9ITL9DACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
SUCROSEC151H8M554IACT

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
AcetaminophenACETAMINOPHENMajor Pharmaceuticals32ea1230-f9ae-46b0-910e-05cd187cee342025-01-09WarningsExact identifier
ndc (package): 0904-7319-70
ndc (package): 0904-7320-02
ndc (package): 0904-7321-76
ndc (package): 0904-7319-41
ndc (package): 0904-7320-71
ndc (package): 0904-7321-03
ndc (product): 0904-7319
ndc (product): 0904-7320
ndc (product): 0904-7321
ndc11 (package): 00904732002
ndc11 (package): 00904731970
ndc11 (package): 00904732071
ndc11 (package): 00904731941
ndc11 (package): 00904732103
ndc11 (package): 00904732176
spl id: fb29cf09-7587-42fb-8537-f729fb7557ac
spl set id: 32ea1230-f9ae-46b0-910e-05cd187cee34
AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharma6ec12573-03d6-40c1-9945-d345b401e0622024-08-12WarningsExact identifier
ndc (product): 0121-0657

Reported adverse events (FAERS/openFDA)#

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