Acetaminophen Oral Solution

Manufacturer
Cardinal Health
Effective date
2020-10-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:10:03

Label at a glance#

ProductAcetaminophen Oral Solution
Active ingredientACETAMINOPHEN
Label structure12 sections

Indications and uses

  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 • muscular aches

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each 20.3 mL cup) Acetaminophen USP 650 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever / fever reducer

Deliver 20.3 mL

Indications and Usage

INDICATIONS & USAGE SECTION

  1. Uses temporarily relieves minor aches and pains due to:
  2. minor pain of arthritis
  3. muscular aches
  4. backache
  5. premenstrual and menstrual cramps
  6. the common cold
  7. headache
  8. toothache
  9. temporarily reduces fever
  10. muscular aches

Instructions For Use

INSTRUCTIONS FOR USE SECTION

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 use more than 10 days unless directed by a doctor

under 18 years of age

ask a doctor

Warnings

WARNINGS SECTION

Warnings

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

Do not use

  • 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

Other Safety Information

Other 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

Ask Doctor

OTC - ASK DOCTOR SECTION

  • Before use if the user:
  • has liver disease
  • is pregnant or breast-feeding ____________________________________________________________________________

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

Stop Use

OTC - STOP USE SECTION

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 of a serious condition

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Acetaminophen Oral Solution, USP

650 mg/ 20.3 mL

5 Cups

bag label
bag label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6820-76ML - Milliliter0904-6820150e4960-a27b-422a-bebd-2aa954795c1712019-05-02

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
55154-336055154-3360-5
0904-6820

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

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
84e81174-d273-4642-81d6-af2267597a6756636372-50e3-4e6f-aeb1-c958a1fcd49b2022-12-28WarningsExact identifier
spl set id: 56636372-50e3-4e6f-aeb1-c958a1fcd49b

Reported adverse events (FAERS/openFDA)#

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