JUNIOR STRENGTH ADVIL

JUNIOR STRENGTH ADVIL is an FDA-registered drug product whose active ingredient is IBUPROFEN. It is labelled by Proficient Rx LP taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 71205-425, application NDA020944, label effective 20200301. It is one of 362 FDA drug label records sharing the active ingredient IBUPROFEN. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing IBUPROFEN are most often described in connection with: temporarily reduces, fever relieves, minor aches, pains due, common cold, flu sore, throat headaches. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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

DIRECTIONS • this product does not contain directions or complete warnings for adult use • do not give more than directed • 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 (tablets) under 24 lb under 2 yr ask a doctor 24-35 lb 2-3 yr 1 tablet 36-47 lb 4-5 yr 1 ½ tablets 48-59 lb 6-8 yr 2 tablets 60-71 lb 9-10 yr 2 ½ tablets 72-95 lb 11 yr 3 tablets

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 • 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.

FDA lists 362 drug label records with IBUPROFEN as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is JUNIOR STRENGTH 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 JUNIOR STRENGTH ADVIL?
Proficient Rx LP is the labeler of record for JUNIOR STRENGTH ADVIL. 362 FDA label records share the active ingredient IBUPROFEN, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does JUNIOR STRENGTH ADVIL come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is JUNIOR STRENGTH ADVIL prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing IBUPROFEN?
Yes. 362 FDA drug label records list IBUPROFEN as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has JUNIOR STRENGTH ADVIL been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.