Esgic-Plus Oral

In the U.S.

• Anolor 300
• Dolgic LQ
• Esgic
• Esgic-Plus
• Ezol
• Fioricet
• Geone
• Margesic
• Medigesic
• Nonbac
• Pacaps
• Repan

Available Dosage Forms:

• Capsule
• Tablet
• Solution

Therapeutic Class: Butalbital/Acetaminophen Combination

Pharmacologic Class: Barbiturate

Chemical Class: Methylxanthine

It is very important that your doctor check your progress while you or your child are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

This medicine may be habit-forming. If you or your child feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loose skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

This medicine may make you dizzy or drowsy. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Also, there may be a greater risk of liver damage if you drink three or more alcoholic beverages while you are taking acetaminophen. Do not drink alcoholic beverages, and check with your doctor before taking any of these medicines while you are using this medicine.

Before you have any medical tests, tell the medical doctor in charge that you or your child are taking this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Lightheadedness
• shortness of breath

• Abdominal or stomach pain
• black, tarry stools
• bleeding gums
• blistering, peeling, or loosening of the skin
• blood in the urine or stools
• blurred vision
• change in the frequency of urination or amount of urine
• chills
• cough
• diarrhea
• difficulty with breathing
• difficulty with swallowing
• dizziness
• drowsiness
• dry mouth
• fainting
• fast, pounding, or irregular heartbeat or pulse
• flushed or dry skin
• fruit-like breath odor
• hives, itching, or skin rash
• increased hunger
• increased thirst
• increased urination
• joint or muscle pain
• loss of appetite
• nausea or vomiting
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• seizures
• shakiness in the legs, arms, hands, or feet
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• sweating
• swelling of the feet or lower legs
• tightness in the chest
• trembling or shaking of the hands or feet
• troubled breathing
• unexplained weight loss
• unusual bleeding or bruising
• unusual tiredness or weakness
• weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

• Confusion as to time, place, or person
• dark urine
• difficult or painful urination
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fever
• general feeling of discomfort or illness
• hallucinations
• headache
• holding false beliefs that cannot be changed by fact
• increased sweating
• irregular, fast or slow, or shallow breathing
• light-colored stools
• loss of appetite
• pale or blue lips, fingernails, or skin
• restlessness
• sudden decrease in the amount of urine
• sweating
• trouble sleeping
• unpleasant breath odor
• unusual excitement, nervousness, or restlessness
• vomiting of blood
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Relaxed and calm
• sleepiness

• Anxiety
• bloated
• constipation
• continuing ringing or buzzing or other unexplained noise in the ears
• depression
• earache
• excess air or gas in the stomach or intestines
• false or unusual sense of well-being
• full feeling
• hearing loss
• heartburn
• heavy eyelids
• high energy
• hot spells
• hyperventilation
• irritability
• numbness
• pain in the leg
• passing gas
• sluggishness
• stuffy nose
• tingling sensation

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also Warning section.

Nausea, vomiting, abdominal pain, constipation, dry mouth, shaking (tremor), shortness of breath, increased urination, lightheadedness, dizziness, drowsiness, or trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: mental/mood changes, fainting, seizures, fast/irregular heartbeat.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.

Before taking this medication, tell your doctor or pharmacist if you are allergic to acetaminophen, caffeine, or butalbital; or to other barbiturates (such as phenobarbital) or xanthine derivatives (such as theophylline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: severe breathing problems (such as bronchopneumonia), a certain enzyme disorder (porphyria), liver disease, kidney disease, personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), mental/mood disorders, abdominal/stomach problems (such as stomach ulcer).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Liquid products may contain alcohol, sugar and/or aspartame. Caution is advised if you have diabetes, alcohol dependence, liver disease, phenylketonuria (PKU), or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely.

Before having surgery or certain medical procedures (such as a heart stress test or a procedure to restore a normal heart rhythm if you have an unusually fast heartbeat), tell your doctor or dentist that you use this medication and about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially drowsiness and trouble falling asleep. These side effects can increase the risk of falling.

During pregnancy, this medication should be used only when clearly needed. Using it for long periods or in high doses near the expected delivery date is not recommended because of possible harm to the unborn baby. Discuss the risks and benefits with your doctor. Infants born to mothers who have used this medication for an extended time may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, seizures, or diarrhea. Tell your doctor right away if you notice any of these symptoms in your newborn.

This drug passes into breast milk and could have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Applies to acetaminophen / butalbital / caffeine: oral capsule, oral solution, oral tablet

Along with its needed effects, acetaminophen / butalbital / caffeine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking acetaminophen / butalbital / caffeine:

• Lightheadedness
• shortness of breath

• Abdominal or stomach pain
• black, tarry stools
• bleeding gums
• blistering, peeling, or loosening of the skin
• blood in the urine or stools
• blurred vision
• change in the frequency of urination or amount of urine
• chills
• cough
• diarrhea
• difficulty with breathing
• difficulty with swallowing
• dizziness
• drowsiness
• dry mouth
• fainting
• fast, pounding, or irregular heartbeat or pulse
• flushed or dry skin
• fruit-like breath odor
• hives, itching, or skin rash
• increased hunger
• increased thirst
• increased urination
• joint or muscle pain
• loss of appetite
• nausea or vomiting
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• seizures
• shakiness in the legs, arms, hands, or feet
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• sweating
• swelling of the feet or lower legs
• tightness in the chest
• trembling or shaking of the hands or feet
• troubled breathing
• unexplained weight loss
• unusual bleeding or bruising
• unusual tiredness or weakness
• weakness

Get emergency help immediately if any of the following symptoms of overdose occur while taking acetaminophen / butalbital / caffeine:

• Confusion as to time, place, or person
• dark urine
• difficult or painful urination
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fever
• general feeling of discomfort or illness
• hallucinations
• headache
• holding false beliefs that cannot be changed by fact
• increased sweating
• irregular, fast or slow, or shallow breathing
• light-colored stools
• loss of appetite
• pale or blue lips, fingernails, or skin
• restlessness
• sudden decrease in the amount of urine
• sweating
• trouble sleeping
• unpleasant breath odor
• unusual excitement, nervousness, or restlessness
• vomiting of blood
• yellow eyes or skin

Some side effects of acetaminophen / butalbital / caffeine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Relaxed and calm
• sleepiness

• Anxiety
• bloated
• constipation
• continuing ringing or buzzing or other unexplained noise in the ears
• depression
• earache
• excess air or gas in the stomach or intestines
• false or unusual sense of well-being
• full feeling
• hearing loss
• heartburn
• heavy eyelids
• high energy
• hot spells
• hyperventilation
• irritability
• numbness
• pain in the leg
• passing gas
• sluggishness
• stuffy nose
• tingling sensation