Acetaminophen Oral Solution USP, 160 mg/5 mL

Manufacturer
Acetris Pharma Holdings, LLC | Invahealth Inc.
Effective date
2026-05-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:57:15

Label at a glance#

ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure9 sections

Indications and uses

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

Dosage and administration

Do not exceed recommended dosage. Overdose Warnings: Taking more than the recommended dose (overdose) can cause serious health problems, including liver damage. adults and children 12 years of age and older: take 2 teaspoonfuls (10 mL) every 6 hours; do not exceed 8 teaspoonfuls (40 mL) in 24 hours children under 12 years of age: Under the direct guidance of a licensed professional, doctor, or pharmacist.

Storage and handling

If dispensed, dispense in a tight, light resistant container with a child-resistant cap. Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F)

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL teaspoonful)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen, USP 160 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains due to:

  • headache
  • muscular aches
  • backache
  • arthritis
  • the common cold
  • toothache
  • menstrual cramps
  • reduces fever

Warnings

WARNINGS SECTION

SPL UNCLASSIFIED SECTION

Liver Warning: This product contains acetaminophen.

Severe liver damage may occur if you take:

  • more than 8 teaspoonfuls (40 mL) in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert

SPL UNCLASSIFIED SECTION

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.

Ask a doctor before use

OTC - ASK DOCTOR SECTION

if you have health issues especially liver disease.

Ask a doctor or pharmacist before use

OTC - ASK DOCTOR/PHARMACIST SECTION

if you are taking other drugs, including the blood thinner warfarin.

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.

  • 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 in this product.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • new symptoms occur such as rash, hives, itching or hoarseness
  • redness or swelling is present
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • symptoms do not improve

These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

Do not exceed recommended dosage.

SPL UNCLASSIFIED SECTION

Overdose Warnings: Taking more than the recommended dose (overdose) can cause serious health problems, including liver damage.

  • adults and children 12 years of age and older: take 2 teaspoonfuls (10 mL) every 6 hours; do not exceed 8 teaspoonfuls (40 mL) in 24 hours
  • children under 12 years of age: Under the direct guidance of a licensed professional, doctor, or pharmacist.

Other information

STORAGE AND HANDLING SECTION

If dispensed, dispense in a tight, light resistant container with a child-resistant cap.

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Cherry Flavor, Citric Acid, FD&C Red No. 40, Glycerin, Polyethylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate Dihydrate, Sodium Saccharin, Sorbitol.

Questions or comments?

OTC - QUESTIONS SECTION

1-833-395-6929

Distributed by:

Acetris Pharma Holdings, LLC

East Brunswick, NJ 08816

Issued:05/2026

PRINCIPAL DISPLAY PANEL—118 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 52343-555-12

Acetaminophen Oral Solution USP
160 mg/5 mL

Pain Reliever

Fever Reducer

Sugar Free

Alcohol Free

Aspirin Free

Cherry Flavor

4 fl. oz. (118 mL)

acetaminophen-os-118mLacetaminophen-os-118mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307675acetaminophen 160 MG in 5 mL Oral SolutionPSN1
307675acetaminophen 32 MG/ML Oral SolutionSCD1
307675acetaminophen 160 MG per 5 ML Oral SolutionSY1
307675acetaminophen 325 MG per 10.15 ML Oral SolutionSY1
307675acetaminophen 650 MG per 20.3 ML Oral SolutionSY1
307675acetaminophen 80 MG per 2.5 ML Oral SolutionSY1
307675APAP 32 MG/ML Oral SolutionSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52343-555-12Acetaminophen118 mL in 1 BOTTLE, PLASTICSOLUTION1181

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52343-55552343-555-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
AcetaminophenACETAMINOPHENAcetris Pharma Holdings, LLCdacbe2eb-f412-4629-a8ff-237c7fd10ab62026-05-13WarningsExact identifier
ndc (package): 52343-555-12
ndc (product): 52343-555
ndc11 (package): 52343055512
spl id: 68776ec5-dc83-4edb-b117-3326c2d999aa
spl set id: dacbe2eb-f412-4629-a8ff-237c7fd10ab6

Reported adverse events (FAERS/openFDA)#

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