Boxed Warning

12/2023

Indications and Usage (1)

12/2023

Dosage and Administration (2.1, 2.3, 2.4)

12/2023

Warnings and Precautions (5.6)

12/2023

Medication Guide

Morphine Sulfate (mor’ feen sul’ fate) Tablets CII

Rx only

Morphine sulfate tablets are:

• A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage short-term (acute) pain and long-term (chronic) 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 morphine sulfate tablets:

*Get emergency help or call 911 right away if you take too many morphine sulfate tablets (overdose). When you first start taking morphine sulfate 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 morphine sulfate 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 morphine sulfate tablets. They could die from taking it. Selling or giving away morphine sulfate tablets is against the law.
• Store morphine sulfate 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 morphine sulfate tablets if you have:

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

Before taking morphine sulfate 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:

***noticing your pain getting worse.**If your pain gets worse after you take morphine sulfate tablets, do not take more of morphine sulfate tablets 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 morphine sulfate tablets. *pregnant or planning to become pregnant. Use of morphine sulfate 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.**Morphine sulfate passes 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 prescription drugs.
• Taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking morphine sulfate tablets with certain other medicines can cause serious side effects that could lead to death.

When taking morphine sulfate tablets:

• Do not change your dose. Take morphine sulfate tablets 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 morphine sulfate tablets for a few days. You may have some morphine sulfate tablets 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 morphine sulfate tablets.
• Take your prescribed dose every 4 hours as needed for pain. 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 morphine sulfate tablets regularly, do not stop taking morphine sulfate without talking to your healthcare provider.
• Dispose of expired, unwanted, or unused morphine sulfate tablets 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 morphine sulfate tablets DO NOT:

• Drive or operate heavy machinery, until you know how morphine sulfate affects you. Morphine sulfate 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 morphine sulfate tablets may cause you to overdose and die.

The possible side effects of morphine sulfate tablets:

• 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, lightheadedness 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 morphine sulfate tablets. Call your healthcare provider 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.

Manufactured by: SpecGx LLC, Webster Groves, MO 63119 USA,
www.mallinckrodt.com or call 1-800-778-7898****
Mallinckrodt™