Actavis Pharma, Inc.
Hydrocodone Bitartrate (hye” droe koe’ done bye tar’ trate) and Ibuprofen (eye" bue proe'
fen) Tablets), CII
Hydrocodone bitartrate and ibuprofen tablets are:
A strong prescription pain medicine that contains an opioid (narcotic) and a non-steroidal anti-
inflammatory drug (NSAID), that is used to manage short-term (acute) pain, when other pain
treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot
An opioid pain medicine can put you at risk for overdose and death. Even if you take your dose
correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to
NSAIDs are used to treat pain, redness, swelling, and inflammation.
Important information about hydrocodone bitartrate and ibuprofen tablets:
Get emergency help right away if you take too much hydrocodone bitartrate and ibuprofen
tablets (overdose). When you first start taking hydrocodone bitartrate and ibuprofen
tablets, when your dose is changed, or if you take too much (overdose), serious or life-
threatening breathing problems that can lead to death may occur.
Taking hydrocodone bitartrate and ibuprofen
tablets with other opioid medicines, benzodiazepines, alcohol, or other central
nervous system depressants (including street drugs) can cause severe drowsiness, decreased
awareness, breathing problems, coma, and death.
Never give anyone else your hydrocodone bitartrate and ibuprofen tablets. They could die from
taking it. Store hydrocodone bitartrate and ibuprofen tablets away from children and in a
safe place to prevent stealing or abuse. Selling or giving away hydrocodone bitartrate and
ibuprofen tablets is against the law.
Hydrocodone bitartrate and ibuprofen tablet contains an NSAID. NSAIDs can
cause serious side effects, including:
Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in
treatment and may increase:
○ 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.
Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading
from the mouth to the stomach), stomach and intestines:
o any time during use
o without warning symptoms
o 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
○ older age
○ longer use of NSAIDS
○ poor health
○ advanced liver disease
○ drinking alcohol
○ bleeding problems
Do not take hydrocodone bitartrate and ibuprofen tablets:
if you have severe asthma, trouble breathing, or other lung problems.
if you have a bowel blockage or have narrowing of the stomach or intestines.
if you have had an asthma attack, hives, or other allergic reaction with aspirin, other NSAIDs, or
right before or after heart bypass surgery.
Before taking hydrocodone bitartrate and ibuprofen
tablets, tell your healthcare provider if you have a history of:
head injury or seizures
liver, kidney, or thyroid problems
pancreas or gallbladder problems
high blood pressure
abuse of street or prescription drugs, alcohol addiction, or mental health problems.
Tell your healthcare provider if you are:
pregnant or planning to become pregnant. Talk to your healthcare provider if you are
considering taking hydrocodone bitartrate and ibuprofen
tablets during pregnancy. Prolonged use of hydrocodone bitartrate and ibuprofen tablets during
pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if
not recognized and treated. You should not take NSAIDs after 29 weeks of pregnancy.
breastfeeding or planning to breastfeed. Hydrocodone bitartrate and ibuprofen
passes into breast milk and may harm your baby.
taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking
hydrocodone bitartrate and ibuprofen
tablets with certain other medicines can cause serious side effects that could lead to death.
When taking hydrocodone bitartrate and ibuprofen tablets:
Do not change your dose. Take hydrocodone bitartrate and ibuprofen
tablets exactly as prescribed by your healthcare provider.
Use the lowest dose possible for the shortest time needed.
Take your prescribed dose every 4 to 6 hours, as needed. Do not take more than your
prescribed dose. If you miss a dose, take your next dose at your usual time.
Call your healthcare provider if the dose you are taking does not control your pain.
If you have been taking hydrocodone bitartrate and ibuprofen tablets regularly, do
not stop taking it without talking to your healthcare provider.
After you stop taking hydrocodone bitartrate and ibuprofen
tablets, flush any unused tablets down the toilet or contact the
Drug Enforcement Agency (DEA) to find the location of an authorized collector (1-800-882-
9539) after you stop taking hydrocodone bitartrate and ibuprofen tablets.
While taking hydrocodone bitartrate and ibuprofen tablets DO NOT:
drive or operate heavy machinery, until you know how it affects you. Hydrocodone bitartrate and
ibuprofen tablets can make you sleepy, dizzy, or lightheaded.
drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using produc
ts containing alcohol during treatment with hydrocodone bitartrate and ibuprofen
tablets may cause you to overdose and die.
The possible side effects of hydrocodone bitartrate and ibuprofen tablets:
constipation, diarrhea, gas, heartburn, nausea, sleepiness, vomiting, tiredness, headache,
dizziness, abdominal pain, heart attack, stroke, new or worse high blood pressure, heart failure,
liver problems including liver failure, kidney problems including kidney failure, bleeding and ulce
rs in the stomach and intestine, low red blood cells (anemia), life-threatening skin reactions, life-
threatening allergic reactions, asthma attacks in people who have asthma. Call your healthcare
provider if you have any of these symptoms and they are severe.
Get emergency medical help if you have:
trouble breathing or shortness of breath
high body temperature
swelling of your face, tongue, or throat
mental changes such as confusion
lightheadedness when changing positions
weakness in one part or side of your body
a fainting spell
Stop hydrocodone bitartrate and ibuprofen
tablets and call your healthcare provider right away if you have any of the following symptoms:
more tired or weaker than usual
there is blood in your bowel movement or it is
black and sticky like tar
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
These are not all the possible side effects of hydrocodone bitartrate 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.
Aspirin is an NSAID medicine, 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
Do not take other NSAID medicines, even those sold in lower doses without a prescription (over-
the-counter) while taking hydrocodone bitartrate and ibuprofen tablets. NSAIDs may be present in
over-the-counter medications for treatment of colds, fever, or insomnia.
Actavis Laboratories FL, Inc.
Fort Lauderdale, FL 33314 USA
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Revised: January 2017
Document Id: e5666a18-5187-4405-b7c5-a45736cdedde
Set id: 9cc32777-1f3b-4309-b2eb-ca165ad56aca
Effective Time: 20170101
Actavis Pharma, Inc.