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Ibu (Ibuprofen): Uses, Side Effects and Dosage

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Facts
Status:
Prescription (Rx) Boxed warning
Strength:
800 mg
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Active ingredient:
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Ibu

What are NSAIDs?

NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain.

Who should not NSAIDs?

Do not take NSAIDs:

  • if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs
  • right before or after heart bypass surgery

Before taking NSAIDs, tell your healthcare provider about all your medical conditions, including if you:

  • have liver or kidney problems
  • have high blood pressure
  • have asthma

  • are pregnant or plan to become pregnant. Talk to your healthcare provider if you are considering taking NSAIDs during pregnancy. You should not take NSAIDs after 29 weeks or pregnancy.

  • are breastfeeding or plan to breast feed

Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements. NSAIDs and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first.

What are the possible side effects of NSAIDs?

NSAIDs can cause serious side effects, including:

See "What is the most important information I should know about medicines called Nonsterodial Anti-Inflammatory Drugs (NSAIDs)?"

  • new or worse high blood pressure • low red blood cells (anemia)
  • heart failure • life-threatening skin reactions
  • liver problems including liver failure • life-threatening allergic reactions
  • kidney problems including kidney failure
  • Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.

Get emergency help right away if you have any of the following symptoms:

  • shortness of breath or trouble breathing • slurred speech
  • chest pain • swelling of the face or throat
  • weakness in one part or side of your body

Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:

  • nausea • vomit blood
  • more tired or weaker than usual • there is blood in your bowel movement or it is black and sticky like tar
  • diarrhea • unusual weight gain
  • itching • skin rash or blisters with fever
  • your skin or eyes look yellow • swelling of the arms, legs, hands and feet
  • indigestion or stomach pain • flu-like symptoms

If you take too much of your NSAIDs, call your healthcare provider or get medical help right away.

These are not all the possible side effects of NSAIDs. For more information, ask your healthcare provider or pharmacist about NSAIDs.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other information about NSAIDs

•Aspirin is an NSAID but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.

  • Some of NSAIDs are sold in lower doses without a prescription (over-the-counter) Talk to your healthcare provider before using over- the-counter NSAIDs for more than 10 days.

General information about the safe and effective use of NSAIDs

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not us NSAIDs for a condition for which it was not prescribed. Do not give NSAIDs to other people, even if they have the same symptoms that you have. It may harm them.

If you would like more information about NSAIDs, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about NSAIDs that is written for professionals.

IBU™ Ibuprofen Tablets USP 400 mg, 600 mg, and 800 mg Rx - ANDA# 075682

Manufacturing facility: Dr. Reddy's Laboratories Louisiana, LLC - Shreveport, LA 71106 USA

Distributed by: Dr. Reddy's Laboratories, Inc.

For more info, call/contact: 1-888-375-3784

This Medication Guide has been approved by the U.S. Food and Drug Administration

Revised May 2016

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 075682 · View the label on DailyMed

Revision date stated in the text: May 2016

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Ibu

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Nonsteroidal Anti-inflammatory Drug
Active ingredient Ibuprofen 800 mg
Dosage form Tablet
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) DR REDDYS
FDA approval ANDA 075682Abbreviated New Drug Application (ANDA) – generic drug Approved November 14, 2001
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
800 mg – 12 in 1 bottle NDC 68071-3053-0
800 mg – 20 in 1 bottle NDC 68071-3053-2
800 mg – 40 in 1 bottle NDC 68071-3053-4
800 mg – 60 in 1 bottle NDC 68071-3053-6
800 mg – 120 in 1 bottle NDC 68071-3053-1

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.