Oxycodone (ox” i koe’ done) HCl Tablets USP, CII
Oxycodone HCl tablets are:
- A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require an opioid pain medicine, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
- An opioid pain medicine that 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 death.
Important information about oxycodone HCl tablets:
Get emergency help or call 911 right away if you take too much oxycodone HCl tablets (overdose). When you first start taking oxycodone HCl 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. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose.
- Taking oxycodone HCl 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 oxycodone HCl tablets. They could die from taking it. Selling or giving away oxycodone HCl is against the law.
- Store oxycodone HCl tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.
Do not take oxycodone HCl tablets if you have:
- severe asthma, trouble breathing, or other lung problems.
- a bowel blockage or have narrowing of the stomach or intestines.
- allergy to oxycodone.
Before taking oxycodone HCl tablets, tell your healthcare provider if you have a history of:
- head injury, seizures
- liver, kidney, thyroid problems
- problems urinating
- pancreas or gallbladder problems
- abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems.
Tell your healthcare provider if you are:
pregnant or planning to become pregnant. Prolonged use of oxycodone HCl tablets during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
breastfeeding. Oxycodone HCl passes into breast milk and may harm your baby.
- living in a household where there are small children or someone who has abused street or prescription drugs
- taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking oxycodone HCl tablets with certain other medicines can cause serious side effects that could lead to death.
When taking oxycodone HCl tablets:
- Do not change your dose. Take oxycodone HCl 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. 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 oxycodone HCl tablets regularly, do not stop taking oxycodone HCl tablets without talking to your healthcare provider.
- Dispose of expired, unwanted, or unused oxycodone HCl by promptly flushing down the toilet, if a drug take-back option is not readily available. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.
While taking oxycodone HCl tablets DO NOT:
- Drive or operate heavy machinery, until you know how oxycodone HCl tablets affects you. Oxycodone HCl tablets can make you sleepy, dizzy, or lightheaded.
- Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with oxycodone HCl tablets may cause you to overdose and die.
The possible side effects of oxycodone HCl tablets are:
These are not all the possible side effects of oxycodone HCl 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
Amneal Pharmaceuticals of NY, LLC
Brookhaven, NY 11719
www.amneal.com or call 1-877-835-5472
This Medication Guide has been approved by the U.S. Food and Drug Administration.