Acetaminophen Solution
FDA Label NDC 52343-555

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Acetris Pharma Holdings, Llc for the product Acetaminophen (NDC 52343-555). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredient (in each 5 ml teaspoonful), purpose, uses, warnings, allergy alert, ask a doctor before use, ask a doctor or pharmacist before use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient (In Each 5 Ml Teaspoonful)

Acetaminophen, USP 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:

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

Warnings

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.

Ask A Doctor Before Use

if you have health issues especially liver disease.

Ask A Doctor Or Pharmacist Before Use

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

Otc - Do Not Use

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

  • 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

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

Otc - Keep Out Of Reach Of Children

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

Do not exceed recommended dosage.

Other Information

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

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?

1-833-395-6929

Distributed by:

Acetris Pharma Holdings, LLC

East Brunswick, NJ 08816

Issued:05/2026

Principal Display Panel—118 Ml Bottle Label

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-118ml (Acetaminophen Os 118ml)

Acetaminophen-os-118ml (Acetaminophen Os 118ml)

* Please review the disclaimer below.