FDA approved Children's Advil (ibuprofen) for Fever and Minor Aches in ChildrenFDA approved Children's Advil for fever and pain in kids ages 2 and up.

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

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. The dosing chart includes children aged 2 to 11 years (weight 24-95 lb). Children under 2 years or under 24 lb should consult a doctor.

Dosing is based on weight (preferred) or age. Repeat dose every 6-8 hours as needed, not more than 4 times per day. Dosing chart: 24-35 lb (2-3 yr): 1 tablet; 36-47 lb (4-5 yr): 1.5 tablets; 48-59 lb (6-8 yr): 2 tablets; 60-71 lb (9-10 yr): 2.5 tablets; 72-95 lb (11 yr): 3 tablets. Do not use more than directed.

Trial data not available in label.

Contraindications: Do not use if child has had allergic reaction to any pain reliever/fever reducer, or right before or after heart surgery. Warnings: Allergy alert (severe allergic reaction including hives, facial swelling, asthma, shock, skin reddening, rash, blisters); stomach bleeding warning (higher risk with prior ulcers, bleeding problems, anticoagulant/steroid use, other NSAIDs, or exceeding dose); heart attack and stroke warning (NSAIDs increase risk of heart attack, heart failure, stroke, which can be fatal); sore throat warning (severe/persistent sore throat with high fever, headache, nausea, vomiting may be serious). Ask a doctor before use if child has stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, stroke, dehydration, vomiting/diarrhea, or is taking diuretic. Stop use and ask a doctor if signs of stomach bleeding (faintness, vomiting blood, bloody/black stools, stomach pain not improving), heart problems or 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.

Children's Advil is an over-the-counter option for fever and mild pain in children aged 2 years and older. It should be used at the lowest effective dose for the shortest duration. Clinicians should counsel caregivers on proper dosing, risks of stomach bleeding and cardiovascular events, and when to seek medical attention.