Synalgos-DC

Generic Name: aspirin/caffeine/dihydrocodeine (AS-pir-in/kaf-EEN/dye-hye-droe-KOE-deen)
Brand Name: Synalgos-DC

Some children have had serious and sometimes fatal breathing problems when using codeine after surgery to remove tonsils or adenoids. Talk with your doctor for more information.


Synalgos-DC is used for:

Preventing or relieving moderate to severe pain.

Synalgos-DC is an analgesic combination. It works by binding to the opioid receptors in the brain and spinal cord and decreasing prostaglandins, which reduces pain.

Do NOT use Synalgos-DC if:

  • you are allergic to any ingredient in Synalgos-DC or have had a severe allergic reaction to codeine, hydrocodone, dihydrocodeine, or oxycodone (eg, Tylox, Tylenol with codeine, Vicodin), or aspirin or similar medicines
  • you have severe diarrhea due to taking an antibiotic
  • you have any serious bleeding, hemophilia, low platelets (thrombocytopenia), or a history of blood or clotting disorders
  • you are taking clopidogrel, heparin, a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen), probenecid, sodium oxybate (GHB), or sulfinpyrazone
  • if you have had an unusual or allergic reaction to ibuprofen, naproxen, NSAIDs, or any other medicine used to treat pain, fever, swelling, or arthritis
  • if you are a child with chickenpox or flu symptoms
  • if you have Von Willebrand disease
  • the patient is a child and has just had surgery to remove tonsils or adenoids

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: 2014 Update - First Time Brand-to-Generic Switches

Before using Synalgos-DC:

Some medical conditions may interact with Synalgos-DC. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have asthma, breathing problems, nasal polyps, chickenpox, or flu symptoms
  • if you have a current or recent head injury, growths or cancer of the brain, a brain aneurysm, increased pressure in the head, or a history of seizures
  • if you have kidney, liver, or heart problems; stomach problems; peptic ulcers; bowel disease; difficulty urinating due to an enlarged prostate or narrow urethra, or have had intestinal surgery
  • if you have a history of substance abuse or dependence, alcoholism, or suicidal thoughts or behaviors
  • if you have Kawasaki syndrome, rheumatic disease, the blood disease porphyria, vitamin K deficiency, bleeding problems, or an underactive thyroid

Some MEDICINES MAY INTERACT with Synalgos-DC. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Naltrexone or NSAIDs (eg, ibuprofen) because they may decrease Synalgos-DC's effectiveness
  • Barbiturate anesthetics (eg, thiopental), cimetidine, HIV protease inhibitors (eg, ritonavir), other opiates (eg codeine), phenothiazines (eg, chlorpromazine), or sodium oxybate (GHB) because side effects, such as increased sedation, respiratory depression, seizures, and disorientation, may occur
  • Anticoagulants (eg, warfarin), celecoxib, clopidogrel, or heparin because side effects, such as increased risk of bleeding and ulcers, may occur
  • Carbonic anhydrase inhibitors (eg, brinzolamide) because they may decrease Synalgos-DC's effectiveness while the risk of their actions and side effects may be increased
  • Insulin, meglitinide antidiabetics (eg, repaglinide), methotrexate, sulfonylureas (eg, glyburide), or valproic acid because the risk of their actions and side effects may be increased by Synalgos-DC
  • Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), probenecid, or sulfinpyrazone because their effectiveness may be decreased by Synalgos-DC

This may not be a complete list of all interactions that may occur. Ask your health care provider if Synalgos-DC may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Synalgos-DC:

Use Synalgos-DC as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take Synalgos-DC by mouth with or without food.
  • If you miss a dose of Synalgos-DC, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Synalgos-DC.

Important safety information:

  • Synalgos-DC may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Synalgos-DC with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Synalgos-DC; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Serious stomach ulcers or bleeding can occur with the use of Synalgos-DC. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Synalgos-DC with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.
  • Aspirin has been linked to a serious illness called Reye syndrome. Do not give Synalgos-DC to a child or teenager who has the flu, chickenpox, or a viral infection. Contact your doctor with any questions or concerns.
  • Tell your doctor or dentist that you take Synalgos-DC before you receive any medical or dental care, emergency care, or surgery.
  • Synalgos-DC has aspirin in it. Before you start any new medicine, check the label to see if it has aspirin in it too. If it does or if you are not sure, check with your doctor or pharmacist.
  • If you are taking aspirin prescribed by your doctor for reasons such as heart attack and stroke prevention, check with your doctor to see if you should take it with Synalgos-DC.
  • Lab tests, including liver function, may be performed while you use Synalgos-DC. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Synalgos-DC with caution in the ELDERLY; they may be more sensitive to its effects, especially if they have blood clotting disorders.
  • Synalgos-DC should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Synalgos-DC while you are pregnant. Synalgos-DC is not recommended during the last 3 months (third trimester) of pregnancy because it may cause harm to the fetus. Synalgos-DC is found in breast milk. If you are or will be breast-feeding while you use Synalgos-DC, check with your doctor. Discuss any possible risks to your baby.

When used for long periods of time or at high doses, Synalgos-DC may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Synalgos-DC stops working well. Do not take more than prescribed.

Some people who use Synalgos-DC for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you suddenly stop taking Synalgos-DC, you may experience WITHDRAWAL symptoms, including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; pain; rapid heartbeat; rigid muscles; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; trouble sleeping; or vomiting.

Possible side effects of Synalgos-DC:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Blurred vision; constipation; dizziness; drowsiness; heartburn; lightheadedness; nausea; upset stomach; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black stools; confusion; diarrhea; difficulty swallowing; excessive drowsiness; hearing loss; hoarseness; mood or mental changes; ringing in the ears; shortness of breath; sweating.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include cold and clammy skin; decreased pupil size; difficulty hearing; dizziness; headache; nausea; loss of consciousness; ringing in the ears; slow and shallow breathing; sweating; thirst; unusual sleepiness; vomiting.

Proper storage of Synalgos-DC:

Store Synalgos-DC at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Synalgos-DC out of the reach of children and away from pets.

General information:

  • If you have any questions about Synalgos-DC, please talk with your doctor, pharmacist, or other health care provider.
  • Synalgos-DC is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Synalgos-DC or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Synalgos-DC. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Synalgos-DC. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Synalgos-DC.

Issue Date: December 3, 2014
Database Edition 14.4.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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