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.

• abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems

Tell your healthcare provider if you are:

• Noticing your pain getting worse. If your pain gets worse after you take DILAUDID, do not take more of DILAUDID without first talking to your healthcare provider. Talk to your healthcare provider if the pain that you have increases, if you feel more sensitive to pain, or if you have new pain after taking DILAUDID.
• Pregnant or planning to become pregnant. Use of DILAUDID Tablets and DILAUDID Oral Solution for an extended period of time during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
• Breastfeeding. DILAUDID Tablets and DILAUDID Oral Solution pass into breast milk and may harm your baby. Carefully observe infants for increased sleepiness (more than usual), breathing difficulties, or limpness. Seek immediate medical care if you notice these signs.
• 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.
• For acute (short-term) pain, you may only need to take DILAUDID for a few days. You may have some DILAUDID left over that you did not use. See disposal information at the bottom of this section for directions on how to safely throw away (dispose of) your unused DILAUDID.
• 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.