FDA approved Children's Advil (ibuprofen) for Fever and Minor Aches in ChildrenFDA approved Children's Advil for fever and pain relief in kids.

FDA From the archive Source published June 27, 1996 Summary added May 6, 2026 DOI ↗ Editorial oversight: Dr. Sofia Müller, MD · Lifespan & Whole-Person Care

AI-generated summary of the cited source, checked by automated accuracy review. How we work

Key Takeaway

Consider weight-based dosing for Children's Advil and be aware of NSAID risks including stomach bleeding and cardiovascular events.

The FDA has approved Children's Advil (ibuprofen) oral suspension for over-the-counter use in children to temporarily reduce fever and relieve minor aches and pains associated with the common cold, flu, sore throat, headaches, and toothaches. The approval, based on a decades-old application, provides a standardized dosing chart based on weight or age. Clinicians should note that the product is not intended for adult use and carries warnings about allergic reactions, stomach bleeding, and cardiovascular risks. The dosing cup provided must be used exclusively with this suspension to ensure accurate dosing.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that works by inhibiting prostaglandin synthesis, reducing fever and pain.

Indication & Patient Population

Children's Advil is indicated for temporary reduction of fever and relief of minor aches and pains due to the common cold, flu, sore throat, headaches, and toothaches in children. It is not for adult use.

Dosing & Administration

Shake well before use. Use weight to dose if possible; otherwise use age. Repeat dose every 6-8 hours as needed, not more than 4 times a day. Measure only with the provided dosing cup. Dosing chart: 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.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Allergy alert: may cause severe allergic reaction (hives, facial swelling, asthma, shock, skin reddening, rash, blisters). Stomach bleeding warning: risk higher with history of ulcers, bleeding problems, anticoagulant/steroid use, other NSAIDs, or exceeding dose/duration. Heart attack and stroke warning: NSAIDs increase risk of heart attack, heart failure, stroke; can be fatal. Do not use if allergic to other pain relievers/fever reducers or before/after heart surgery. Ask a doctor before use if stomach bleeding warning applies, history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, stroke, dehydration, vomiting/diarrhea, or taking diuretic. Stop use and ask a doctor if signs of stomach bleeding (faint, vomit blood, bloody/black stools, stomach pain not improving), heart problems/stroke symptoms (chest pain, trouble breathing, weakness, slurred speech, leg swelling), no relief within 24 hours, fever/pain worsens or lasts >3 days, redness/swelling in painful area, or new symptoms appear.

Place in Therapy

Children's Advil is an over-the-counter option for fever and mild pain in children, with weight-based dosing. It should be used cautiously due to risks of stomach bleeding and cardiovascular events, especially with prolonged use or in children with certain medical conditions.

The FDA has approved Children's Advil, a liquid ibuprofen medicine, for over-the-counter use in children. It is used to temporarily reduce fever and relieve minor aches and pains caused by the common cold, flu, sore throat, headaches, and toothaches. This medicine is for children ages 2 to 11 years old. It is not for adults.

This approval is based on a long-standing application and provides a clear dosing chart based on weight or age. The product comes with a special dosing cup that must be used to ensure the right amount is given. Using the wrong cup could lead to incorrect dosing.

While this medicine can help your child feel better, it is important to know that it carries risks. These include allergic reactions, stomach bleeding, and cardiovascular risks. You should always talk to your child's doctor before giving any new medicine, especially if your child has other health conditions or takes other medications.

This approval does not mean that every child should take this medicine. It simply means that the FDA has reviewed the safety and effectiveness data and found it acceptable for over-the-counter use. Always follow the dosing instructions and never give more than the recommended amount.

What this means for you:

Children's Advil is now FDA-approved for fever and pain in kids ages 2 to 11. Always use the dosing cup and talk to your doctor.

Study Details

Study typeFda approval

PublishedJun 1996

View Original Abstract ↓

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

FDA approved Children's Advil (ibuprofen) for Fever and Minor Aches in ChildrenFDA approved Children's Advil for fever and pain relief in kids.

Study Details

High-Dose Vitamin D and Low-Dose Vitamin A May Reduce Bronchopulmonary Dysplasia in Preterm Infants

High-Dose Vitamin D May Reduce BPD in Preterm Infants

Clinical research that matters. Delivered to your inbox.

FDA approved Children's Advil (ibuprofen) for Fever and Minor Aches in ChildrenFDA approved Children's Advil for fever and pain relief in kids.

More on Fever

Study Details

High-Dose Vitamin D and Low-Dose Vitamin A May Reduce Bronchopulmonary Dysplasia in Preterm Infants

High-Dose Vitamin D May Reduce BPD in Preterm Infants

Clinical research that matters. Delivered to your inbox.

Related in Pediatrics

From Other Specialties