MORPHINE SULFATE- morphine sulfate solution 
ANI Pharmaceuticals, Inc.

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Medication Guide

Morphine Sulfate (mor’ feen sul’ fate)

Oral Solution, CII

Morphine Sulfate Oral Solution is:

A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage short term (acute) pain in adults and long term (chronic) pain in adults 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 Oral Solution:

Get emergency help or call 911 right away if you take too much Morphine Sulfate Oral Solution (overdose). When you first start taking Morphine Sulfate 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 Morphine Sulfate 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 Morphine Sulfate Oral Solution. They could die from taking it. Selling or giving away Morphine Sulfate Oral Solution is against the law.
Store Morphine Sulfate 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 Morphine Sulfate Oral Solution 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 Oral Solution, 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 Morphine Sulfate Oral Solution during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
breastfeeding. Morphine Sulfate Oral Solution 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 Morphine Sulfate Oral Solution with certain other medicines can cause serious side effects that could lead to death.

When taking Morphine Sulfate Oral Solution:

Do not change your dose. Take Morphine Sulfate Oral Solution exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
See the detailed Instructions for Use for information about how to take Morphine Sulfate Oral Solution 20 mg/mL in adults who are regularly taking an opioid pain medicine (opioid-tolerant).
Never use a household teaspoon or tablespoon to measure Morphine Sulfate Oral Solution. Your pharmacist should provide you with an oral syringe for giving Morphine Sulfate Oral Solution 2 mg/mL and 4 mg/mL.
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 Oral Solution regularly, do not stop taking Morphine Sulfate Oral Solution without talking to your healthcare provider.
Dispose of expired, unwanted, or unused Morphine Sulfate 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 Morphine Sulfate Oral Solution DO NOT:

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

The possible side effects of Morphine Sulfate 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 Morphine Sulfate 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.

Manufactured by: ANI Pharmaceuticals, Inc., Baudette, MN 56623
For more information, please call 1-800-308-6755.

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This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: May 2022

Pediatric use information is approved for Hikma Pharmaceuticals USA Inc.’s morphine sulfate oral solution. However, due to Hikma Pharmaceuticals USA Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.

Revised: 6/2022
ANI Pharmaceuticals, Inc.