U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Guidance, Compliance, & Regulatory Information
  4. Human Drug Compounding
  5. Questions and Answers on Compounded Oral Suspension Medications for Pain and Fever
  1. Human Drug Compounding

Questions and Answers on Compounded Oral Suspension Medications for Pain and Fever

The US is experiencing challenges related to three viruses: COVID-19, respiratory syncytial virus (RSV) and influenza, any of which can cause fevers in young children. FDA is aware of increased demand for fever and pain-reducing oral suspension medications and that hospitals, health systems, and state-licensed pharmacies report challenges accessing these medications to use for fever and pain treatment of pediatric patients and adults who are unable to swallow solid oral dosage forms (e.g., persons with feeding tubes).

To help address these concerns, in January 2023, FDA issued a guidance that addresses outsourcing facilities’ compounding of certain ibuprofen oral suspension products for administration in hospitals and health systems. FDA subsequently updated the guidance to address the provision of such products to state licensed pharmacies (including those within hospitals and health systems), and to applicable federal facilities, for dispensing to patients following receipt of a patient-specific prescription.

We are continuing to closely monitor the ibuprofen and acetaminophen oral suspension supplies, which have experienced increased demand since the fall of 2022. Companies continue to report inventory and are manufacturing at maximum output. We will continue our monitoring of the market and the companies’ ability to meet demand and will work with companies, within our authorities, on opportunities that will further increase supply. As relevant needs and circumstances related to this temporary policy on compounding ibuprofen oral suspension products evolve, FDA intends to update, modify, or withdraw this policy as appropriate.

What fever-reducing medication is addressed in the FDA immediately-in-effect guidance released in January 2023 and revised in February 2023?

FDA’s guidance addresses the compounding of ibuprofen oral suspension products (100 mg/5 mL) in outsourcing facilities.

Why is FDA not issuing guidance for acetaminophen products, since consumers are also having trouble finding oral suspension formulations?

FDA has received reports related to hospitals, health systems, and pharmacies experiencing challenges with obtaining acetaminophen oral suspension products, which also reduce fever and pain. FDA is not addressing acetaminophen oral suspensions at this time due to additional considerations.

What does the immediately-in-effect guidance say about quality control when preparing ibuprofen oral suspensions?

The guidance identifies steps that should be taken to reduce the risks associated with compounded ibuprofen oral suspension products and indicates that FDA intends to prioritize its regulatory and enforcement actions if these steps are not all followed. See the immediately-in-effect guidance for detailed information and references.

Can 503A compounders make ibuprofen and acetaminophen oral suspensions if a shortage has not been declared?

FDA recognizes significant interest among pharmacy compounding stakeholders in helping address demand and supply issues for pain and fever oral suspension medication. Compounded drugs containing acetaminophen or ibuprofen would need to meet all applicable requirements in section 503A of the FD&C Act. Although section 503A restricts compounded drugs that are essentially copies of commercially available drugs, including those that are not in shortage, certain amounts are permissible under the law as long as the compounding is not done "regularly or in inordinate amounts." All other conditions of section 503A would have to be met, including compounding pursuant to a valid prescription for an identified individual patient. Compounded ibuprofen and acetaminophen oral suspensions would have to comply with all applicable statutory and regulatory requirements, including special packaging standards like child-resistant packaging that are generally required under the Poison Prevention Packaging Act (PPPA).

Accidental overdose of ibuprofen or acetaminophen may have serious health effects. For additional information on packaging and labeling of compounded ibuprofen oral suspension products for dispensing to patients for use at home after receiving a valid, patient-specific prescription, see the immediately-in-effect guidance. For additional information on acetaminophen drug products, including risks involving serious liver damage, see CDER’s acetaminophen page.

What information is available on dosing and risks for ibuprofen oral suspension?

An example of FDA-approved nonprescription labeling for a children’s ibuprofen oral suspension 100mg/5 mL is available below. This labeling information is based on FDA’s premarket review of FDA-approved nonprescription products. The labeling example includes certain content of a typical nonprescription label for a children’s ibuprofen oral suspension, but the example is not formatted per the nonprescription labeling formatting requirements, which can be found in the Code of Federal Regulations (21 CFR 201.66 and other sections). Compounded products do not undergo premarket review and are not FDA-approved.

Household spoons vary widely in volume and should NOT be used for administering medications. A dosing device (e.g., oral dosing syringe or dosing cup) that is appropriately marked in milliliters (mL) provides an accurate measurement.

Example of FDA-approved nonprescription labeling for a children's ibuprofen oral suspension (100mg/5mL)

Drug Facts

Active ingredients (in each 5 mL)

Ibuprofen 100 mg

Purpose (NSAID)* …… Fever reducer/Pain reliever

*nonsteroidal anti-inflammatory drug


  • reduces fever
  • relieves minor aches and pains due to the common cold, flu, sore throat, headaches,
    and toothaches



Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

  • hives
  • facial swelling 
  • asthma (wheezing)
  • shock 
  • skin reddening 
  • rash    
  • blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if the child:

  • has had stomach ulcers or bleeding problems
  • takes a blood thinning (anticoagulant) or steroid drug
  • takes other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • takes more or for a longer time than directed

Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.

Do not use

  • if the child has ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery

Ask a doctor before use if

  • stomach bleeding warning applies to the child
  • child has problems or serious side effects from taking pain relievers or fever reducers
  • child has a history of stomach problems, such as heartburn
  • child has high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had
    a stroke
  • child has not been drinking fluids
  • child has lost a lot of fluid due to vomiting
    or diarrhea
  • child is taking a diuretic

Drug Facts (continues)

Ask a doctor or pharmacist before use if the
child is

  • under a doctor’s care for any serious condition
  • taking any other drug

When using this product 

  • take with food or milk if stomach upset occurs

Stop use and ask a doctor if

  • child experiences any of the following signs of stomach bleeding:
    • feels faint 
    • vomits blood
    • has bloody or black stools
    • has stomach pain that does not get better
  • child has symptoms of heart problems or stroke:
    • chest pain 
    • trouble breathing
    • weakness in one part or
      side of body
    • slurred speech
    • leg swelling
  • the child does not get any relief within first day (24 hours) of treatment
  • fever or pain gets worse or lasts more
    than 3 days
  • redness or swelling is present in the
    painful area
  • any new symptoms appear



  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed
  • shake well before using    
  • mL = milliliter
  • find right dose on chart. If possible, use weight to dose; otherwise
    use age.
  • repeat dose every 6-8 hours, if needed
  • do not use more than 4 times a day


Dosing Chart

Weight (lb)

Age (yr)

Dose (mL)

Under 24 lb

Under 2 yr

Ask a doctor

24-35 lb

2-3 yr

5 mL

36-47 lb

4-5 yr

7.5 mL

48-59 lb

6-8 yr

10 mL

60-71 lb

9-10 yr

12.5 mL

72-95 lb

11 yr

15 mL

Other Resources

Back to Top