Childrens Advil
ibuprofen · Suspension · Oral
Active ingredient
Active ingredient (in each 5 mL) Ibuprofen 100 mg (NSAID)* *nonsteroidal anti-inflammatory drug
Purpose
Purpose Fever reducer/Pain reliever
Uses
Uses temporarily:
• reduces fever
• relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
Warnings
Warnings 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 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 Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Do not use
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
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
Ask a doctor or pharmacist
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
When using this product
• take with food or milk if stomach upset occurs
Stop use and ask a doctor
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
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.
Directions
Directions
• 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 below. 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
• measure only with the dosing cup provided. Dosing cup to be used with Children's Advil Suspension only. Do not use with other products. Dose lines account for product remaining in cup due to thickness of suspension. 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
Inactive ingredients
Inactive ingredients artificial and natural flavors, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucrose, xanthan gum
Questions?
Questions or comments? call toll-free 1-800-88-ADVIL or ask your pharmacist, doctor or health care professional
Label text from the FDA structured product label by Haleon US Holdings LLC (revised Feb 8, 2024). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Ibuprofen in 7 products
Childrens Advil NDC products (7)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 0573-0170 | Ibuprofen 100 mg/5mL Suspension | Haleon US Holdings LLC | NDA |
| 0573-0171 | Ibuprofen 100 mg/5mL Suspension | Haleon US Holdings LLC | NDA |
| 0573-0174 | Ibuprofen 100 mg/5mL Suspension | Haleon US Holdings LLC | NDA |
| 0573-0207 | Ibuprofen 100 mg/5mL Suspension | Haleon US Holdings LLC | NDA |
| 0573-0232 | Ibuprofen 100 mg/5mL Suspension | Haleon US Holdings LLC | NDA |
| 0573-0290 | Ibuprofen 100 mg/5mL Suspension | Haleon US Holdings LLC | NDA |
| 0573-1174 | Ibuprofen 100 mg/5mL Suspension | Haleon US Holdings LLC | NDA |
Childrens Advil recalls
- D-1169-2018 Sep 5, 2018 · Class II · Terminated
Labeling Error: Not elsewhere classified. product has a dosage cup marked in teaspoons and the instructions on the label are described in milliliters.
Frequently asked questions
What is Childrens Advil used for?
Uses temporarily: • reduces fever • relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
Who makes Childrens Advil?
Childrens Advil is listed by 1 labeler in the FDA NDC directory, including Haleon US Holdings LLC.
Has Childrens Advil been recalled?
The FDA enforcement database lists 1 recall for Childrens Advil, most recently D-1169-2018 (class ii): Labeling Error: Not elsewhere classified. product has a dosage cup marked in teaspoons and the instructions on the label are described in milliliters.