Ibuprofen Oral

Ibuprofen Oral is an FDA-registered drug product whose active ingredient is IBUPROFEN ORAL. It is labelled by A-S Medication Solutions taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 50090-4129, application ANDA210602, label effective 20231215. It is one of 2 FDA drug label records sharing the active ingredient IBUPROFEN ORAL. 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 ORAL are most often described in connection with: temporarily relieves, minor aches, pains due, common cold, flu sore, throat headache, toothache reduces. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

USE(S) temporarily: relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache reduces fever

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. If possible, use weight to dose; otherwise use age. · use only enclosed dosing cup. Do not use any other dosing device. · if needed, repeat dose every 6-8 hours · do not use more than 4 times a day · replace original bottle cap to maintain child resistance Dosing Chart Weight (lb) under 24 24-35 lbs 36-47 lbs 48-59 lbs 60-71 lbs 72-95 lbs Age (yr) under 2 years 2-3 years 4-5 years 6-8 years 9-10 years 11 years Dose (mL)* ask a doctor 5 mL 7.5 mL 10 mL 12.5 mL 15 mL *or as directed by a doctor

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 your 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.

FDA lists 2 drug label records with IBUPROFEN ORAL 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.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Ibuprofen Oral used for?
USE(S) temporarily: relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache reduces fever

Who makes Ibuprofen Oral?
A-S Medication Solutions is the labeler of record for Ibuprofen Oral. 2 FDA label records share the active ingredient IBUPROFEN ORAL, 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 Ibuprofen Oral 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 Ibuprofen Oral 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 ORAL?
Yes. 2 FDA drug label records list IBUPROFEN ORAL 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 Ibuprofen Oral been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

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.