OXYCODONE HYDROCHLORIDE AND IBUPROFEN- oxycodone hydrochloride and ibuprofen tablet, film coated 
Actavis Pharma, Inc.

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Medication Guide

Oxycodone Hydrochloride (ox" i koe' done hye" droe klor' ide)
and Ibuprofen (eye" bue proe' fen) Tablets, CII

Oxycodone Hydrochloride and Ibuprofen Tablets are:

Important information about Oxycodone Hydrochloride and Ibuprofen Tablets:

Oxycodone Hydrochloride and Ibuprofen Tablets contain an NSAID. NSAIDs can cause serious side effects including:

             •    with increasing doses of medicine containing NSAIDs

             •    with longer use of medicine containing NSAIDs

Do not take NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG).”

Avoid taking NSAIDs, after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.

             •   any time during use

             •   without warning symptoms

             •   that may cause death

           The risk of getting an ulcer or bleeding increases with:

            •    past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs

            •    taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs”

            •    increasing doses of NSAIDs

            •    longer use of NSAIDs

            •    smoking

            •    drinking alcohol

            •    older age

            •    poor health

            •    advanced liver disease

            •    bleeding problems

Do not take Oxycodone Hydrochloride and Ibuprofen Tablets:

Before taking Oxycodone Hydrochloride and Ibuprofen Tablets, tell your healthcare provider if you have a history of:

Tell your healthcare provider if you are:

When taking Oxycodone Hydrochloride and Ibuprofen Tablets:

 While taking Oxycodone Hydrochloride and Ibuprofen Tablets DO NOT:

The possible side effects of Oxycodone Hydrochloride and Ibuprofen Tablets:

Get emergency medical help if you have: 

  • trouble breathing or shortness of breath
  • agitation 
  • fast heartbeat 
  •  high body temperature
  • chest pain 
  •  trouble walking
  •  swelling of your face, tongue, or throat
  •  stiff muscles
  •  extreme drowsiness                                                         
  •  mental changes such as confusion
  •  lightheadedness when changing positions 
  •  weakness in one part or side of your body
  •  fainting or feel faint   
  •  slurred speech

Stop Oxycodone Hydrochloride and Ibuprofen Tablets and call your healthcare provider right away if you have any of the following symptoms:

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

Other information:

These are not all the possible side effects of Oxycodone Hydrochloride and Ibuprofen Tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov.

For more information about Oxycodone Hydrochloride and Ibuprofen Tablets, call Actavis at 1-800-432-8534.

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

Manufactured by:
Actavis Elizabeth LLC
Elizabeth, NJ 07207 USA

Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Rev. A 4/2019

Revised: 4/2019
Actavis Pharma, Inc.