FDA.reportPublic FDA data

Acetaminophen Oral Solution

Manufacturer
Cardinal Health
Effective date
2022-03-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:04:37

Label at a glance#

ProductAcetaminophen Oral Solution
Active ingredientACETAMINOPHEN
Label structure12 sections

Indications and uses

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

Dosage and administration

• Do not use more than directed • Shake well before use Age (yr) Dose (mL) Adults • take 20.3 mL (650 mg) every 4 to 6 hours • not to exceed 6 doses in a 24-hour period • do not take more than 10 days unless directed by doctor Under 18 years of age • ask a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen USP 325 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/ fever reducer

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 Poison Control Center (1-800-222-

1222) right away. Quick medical attention is critical for adults as well as for children even if you

do not notice any signs or symptoms.

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains due to:

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

Warnings

WARNINGS SECTION

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

  • adults take more than 6 doses in 24 hours which is the maximum daily amount
  • 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

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 you are allergic to acetaminophen or any other inactive ingredients in this product.

Ask Doctor

OTC - ASK DOCTOR SECTION

Ask a doctor before use if this user

  • Has liver disease
  • Is pregnant or breast-feeding

Ask Doctor/Pharmacist

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Stop Use

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • Pain gets worse or lasts more than 10 days
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present

These could be signs or a serious condition

Directions

DOSAGE & ADMINISTRATION SECTION

  • Do not use more than directed
  • Shake well before use

Age (yr)

Dose (mL)

Adults

  • take 20.3 mL (650 mg) every 4 to 6 hours
  • not to exceed 6 doses in a 24-hour period
  • do not take more than 10 days unless directed by doctor

Under 18 years of age

  • ask a doctor

Other Information

OTHER SAFETY INFORMATION

  • store at 20°-25°C (68°-77°F). Avoid excessive heat 40°C (104°F)
  • protect from excessive moisture
  • do not use if lid seal is open or damaged
  • sugar free, dye free, alcohol free
  • see bottom of cup for lot number and expiration date

Inactive Ingredients

INACTIVE INGREDIENT SECTION

cherry flavor, citric acid, glycerin, methylcellulose, microcrystalline cellulose, propyl paraben, propylene glycol, purified water, sodium benzoate, sorbitrol, sucralose, xantham gum

Questions

OTC - QUESTIONS SECTION

Questions or comments?

Call 1-800-616-2471

Rev. 01/19

Generic Section

SPL UNCLASSIFIED SECTION

Distributed By:

MAJOR® PHARMACEUTICALS

Livonia, MI 48152

Distributed By:

Cardinal Health

Dublin, OH 43017

L57472581221

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Acetaminophen Oral Solution, USP

325 mg/10.15 mL

5 Cups

bag label
bag label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6739-71ML - Milliliter0904-673907d1967f-3d77-440a-a178-837230015fc412019-05-02

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
55154-355355154-3553-5
0904-6739

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
GLYCERINPDC6A3C0OXIACT
SODIUM BENZOATEOJ245FE5EUIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SORBITOL506T60A25RIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
53aed601-51dd-4b36-b9ed-e9d9b55d741d21e2e700-8d5b-44ec-b517-cb812bfb59532023-01-04WarningsExact identifier
spl set id: 21e2e700-8d5b-44ec-b517-cb812bfb5953

Reported adverse events (FAERS/openFDA)#

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