DILAUDID- hydromorphone hydrochloride tablet 
DILAUDID- hydromorphone hydrochloride solution 
Rhodes Pharmaceuticals L.P.

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              This Medication Guide has been approved by the U.S. Food and Drug Administration.Issued: 03/2021                        

Medication Guide
DILAUDID® (dī-law-did)
(hydromorphone hydrochloride) Tablets and Oral Solution, CII

DILAUDID Tablets and DILAUDID Oral Solution are:

  • Strong prescription pain medicines that contains an opioid (narcotic) that is used to manage pain severe enough to require an opioid analgesic, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
  • Opioid pain medicines 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 DILAUDID:

  • Get emergency help or call 911 right away if you take too much DILAUDID Tablets or DILAUDID Oral Solution (overdose). When you first start taking DILAUDID Tablets or DILAUDID Oral Solution, 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 DILAUDID Tablets or DILAUDID Oral Solution 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 DILAUDID Tablets or DILAUDID Oral Solution. They could die from taking it. Selling or giving away DILAUDID Tablets or DILAUDID Oral Solution is against the law.
  • Store DILAUDID Tablets or DILAUDID Oral Solution securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

Do not take DILAUDID Tablets or DILAUDID Oral Solution if you have:

  • Severe asthma, trouble breathing, or other lung problems.
  • A bowel blockage or have narrowing of the stomach or intestines.

Before taking DILAUDID Tablets or DILAUDID Oral Solution, tell your healthcare provider if you have a history of:

  • head injury, seizures
  • problems urinating
  • liver, kidney, thyroid problems
  • 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 DILAUDID Tablets and DILAUDID Oral Solution during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
  • Breastfeeding. DILAUDID Tablets or DILAUDID Oral Solution pass into breast milk and may harm your baby.
  • Living in a household where there are small children or someone who has abused street or a prescription drugs.
  • Taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking DILAUDID with certain other medicines can cause serious side effects that could lead to death.

When taking DILAUDID:

  • Do not change your dose. Take DILAUDID exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time 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 DILAUDID Tablets or DILAUDID Oral Solution regularly, do not stop taking DILAUDID Tablets or DILAUDID Oral Solution without talking to your healthcare provider.
  • Dispose of expired, unwanted, or unused DILAUDID Tablets or DILAUDID Oral Solution 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 DILAUDID DO NOT:

  • Drive or operate heavy machinery, until you know how DILAUDID Tablets or DILAUDID Oral Solution affects you. DILAUDID 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 DILAUDID Tablets or DILAUDID Oral Solution may cause you to overdose and die.

The possible side effects of DILAUDID Tablets and DILAUDID Oral Solution:

  • Constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.

Get emergency medical help or call 911 right away if you have:

  • Trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.

These are not all the possible side effects of DILAUDID Tablets and DILAUDID Oral Solution. 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

Marketed by: Rhodes Pharmaceuticals L.P., Coventry, RI 02816 US, http://rhodespharma.com or call 1-888-827-0616

Revised: 3/2021
Rhodes Pharmaceuticals L.P.