Virtussin Dac is a combination of three medications: codeine (an opioid), guaifenesin (an expectorant), and pseudoephedrine (a decongestant). It's used to treat symptoms of the common cold in adults and children, like cough and stuffy nose. But it's not a recommended medication for children younger than 12 years old because of the higher risk of serious side effects. Virtussin Dac is a liquid that's taken by mouth every 4 hours. Side effects include constipation, dizziness, and sleepiness or restlessness. Because Virtussin Dac contains codeine, it's considered a controlled substance.
Please note: Virtussin Dac has been discontinued and is no longer available in the United States. Talk to your care team about alternative options to treat your symptoms.
Temporary relief of common cold symptoms, including:
Cough from minor throat irritations
Stuffy nose (nasal congestion)
Chest congestion
Virtussin Dac is a combination of three medications that work together to relieve symptoms caused by the common cold.
Codeine is an opioid medication. It eases cough by attaching to opioid receptors in the brain that control the urge to cough.
Guaifenesin is an expectorant that loosens mucus in your airways by making it thinner. This makes it easier to cough out mucus and help clear chest congestion.
Pseudoephedrine is a decongestant, which works to relieve stuffy nose. It makes the blood vessels around your nose more narrow, which eases nasal swelling and pressure. This allows you to breathe more freely and to have better sinus drainage.
Virtussin Dac can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk factors: Personal or family history of alcohol or substance use disorder | Personal or family history of mental health problems
Codeine in Virtussin Dac is a controlled substance because it has a risk for addiction and misuse. Take the medication exactly as prescribed. Doing so can raise the risk for serious and possibly life-threatening side effects, such as dangerously slow breathing, inability to stay awake, and opioid overdose. Your healthcare professional (HCP) will prescribe the lowest amount of Virtussin Dac that's necessary to manage your symptoms for the shortest period of time possible.
Because of the risk for misuse and dependency, Virtussin Dac is only available through a Risk Evaluation and Mitigation Strategy (REMS) program called the Opioid Analgesic REMS program. The FDA-required REMS program for Virtussin Dac helps make sure the medication is distributed and used in a safe manner. Your HCP must register with the program and receive training on proper medication use. Under this program, they'll discuss with you about safe and responsible storage, use, and disposal of Virtussin Dac.
Risk factors: Taking medications that can cause slow breathing | Drinking alcohol | Older age | Being frail | Medical conditions that cause breathing problems (e.g., COPD, asthma, head injury) | Taking too much Virtussin Dac
Codeine in Virtussin Dac can cause dangerously slow breathing, which can be life-threatening. This can happen to anyone, but the risk is greatest when you first start treatment or if your prescriber raises the dose. Don't take Virtussin Dac with alcohol or other medications that slow your body down (e.g., benzodiazepines, other opioids, muscle relaxants). Doing so puts you at higher risk of extremely slowed breathing. If you or your loved one notices that you have trouble breathing or have bluish-colored lips, fingers, or toes, call 911 to get medical help right away.
Risk factors: History of opioid use disorder | Previous opioid overdose | Taking high doses of Virtussin Dac | Taking more opioids than prescribed | Alcohol use
Take Virtussin Dac exactly as prescribed. Taking too much Virtussin Dac or taking it more often than prescribed can lead to an accidental overdose. Symptoms of an opioid overdose include not responding to sound or touch, extremely slowed breathing, extreme sleepiness, slow heartbeat, and cold or clammy skin.
Be sure you and your loved ones know how to recognize an overdose. Naloxone is a medication that can treat an opioid overdose. Your HCP might ask you to carry naloxone with you at all times in case you experience an overdose. Call 911 right away if this happens. Store your medication out of reach from children, pets, or visitors to prevent accidental exposure or overdose.
Risk factors: Taking high doses of Virtussin Dac | Age 65 years or older | Younger than 18 years old | Drinking alcohol | Taking other medications that can cause sleepiness
Codeine in Virtussin Dac can cause extreme sleepiness and lower your ability to think, react, and focus. Don't drink alcohol or take other medications that can cause sleepiness or "brain fog" (e.g., benzodiazepines, muscle relaxants, sleep medications) with Virtussin Dac. Doing so can worsen these side effects. Make sure you know how Virtussin Dac affects you before driving a car or doing activities that require your concentration. Talk to your HCP away if you feel too sleepy from taking Virtussin Dac.
Codeine in Virtussin Dac interacts with a lot of common medications. Some medications can raise Virtussin Dac levels in your body, which can raise your risk for side effects and even potentially life-threatening slowed breathing. These medications include erythromycin, ketoconazole, and ritonavir (Norvir).
Other medications, such as rifampin (Rifadin) and carbamazepine (Tegretol), can lower the levels of Virtussin Dac in your body. This can cause Virtussin Dac to not work as well. These interactions might also cause withdrawal symptoms.
If you're already taking stable doses of Virtussin Dac together with one of these other medications, don't stop taking them suddenly without first talking with your prescriber. Doing so can also lead to unsafe Virtussin Dac levels. Let your prescriber or pharmacist know what other medications you're taking before starting Virtussin Dac to make sure your medications are safe for you to take.
If you're pregnant or thinking of becoming pregnant, talk with your HCP before taking Virtussin Dac. This medication isn't recommended in pregnancy because there's chance that pseudoephedrine and codeine in Virtussin Dac can cause harm to unborn babies. If you have cold symptoms during pregnancy, your HCP can talk with you about safer options.
Codeine in Virtussin Dac can cause extremely low blood pressure. Your blood pressure might drop suddenly when you stand from a sitting or lying down position. This can lead to dizziness and fainting. To avoid falling, get up slowly if you've been sitting or lying down. If dizziness or lightheadedness doesn't go away, talk to your healthcare team.
Risk factors: History of seizure conditions
If you've had a seizure in the past, opioids like codeine in Virtussin Dac can raise the risk of having seizures more often. Virtussin Dac can also raise your risk of seizures in certain situations. Get medical help immediately if you have a seizure while taking Virtussin Dac.
Source:Â DailyMed
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.
Although serious side effects occur rarely when this medicine is taken as recommended, they may be more likely to occur if: too much medicine is taken, it is taken in large doses, or it is taken for a long period of time.
Get emergency help immediately if any of the following symptoms of overdose occur:
For narcotic antitussive (codeine, dihydrocodeine, hydrocodone, or hydromorphone)-containing
Cold, clammy skin
confusion (severe)
convulsions (seizures)
drowsiness or dizziness (severe)
nervousness or restlessness (severe)
pinpoint pupils of eyes
slow heartbeat
slow or troubled breathing
If you are a nursing mother and you notice any of the following symptoms of overdose in your baby, get emergency help immediately:
Difficulty breathing
difficulty nursing
increased sleepiness (more than usual)
limpness
For acetaminophen-containing
increased sweating
loss of appetite
nausea or vomiting
stomach cramps or pain
swelling or tenderness in the upper abdomen or stomach area
For salicylate-containing
Any loss of hearing
bloody urine
confusion
convulsions (seizures)
dizziness or lightheadedness
drowsiness (severe)
excitement or nervousness (severe)
fast or deep breathing
hallucinations (seeing, hearing, or feeling things that are not there)
increased sweating
nausea or vomiting (severe or continuing)
shortness of breath or troubled breathing (for salicylamide only)
stomach pain (severe or continuing)
uncontrollable flapping movements of the hands, especially in elderly patients
unusual thirst
vision problems
For decongestant-containing
Fast, pounding, or irregular heartbeat
headache (continuing and severe)
nausea or vomiting (severe)
nervousness or restlessness (severe)
shortness of breath or troubled breathing (severe or continuing)
Check with your doctor as soon as possible if any of the following side effects occur:
For antihistamine- or anticholinergic-containing
Clumsiness or unsteadiness
convulsions (seizures
drowsiness (severe)
dryness of mouth, nose, or throat (severe)
flushing or redness of face
hallucinations (seeing, hearing, or feeling things that are not there)
restlessness (severe)
shortness of breath or troubled breathing
slow or fast heartbeat
For iodine-containing
Headache (continuing)
increased watering of mouth
loss of appetite
metallic taste
skin rash, hives, or redness
swelling of face, lips, or eyelids
For acetaminophen-containing
Unexplained sore throat and fever
unusual tiredness or weakness
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:
decreased sweating
difficult or painful urination
dizziness or lightheadedness
drowsiness
dryness of mouth, nose, or throat
false sense of well-being
increased sensitivity of skin to sun
nausea or vomiting
nightmares
stomach pain
thickening of mucus
trouble in sleeping
unusual excitement, nervousness, restlessness, or irritability
unusual tiredness or weakness
Not all of the side effects listed above have been reported for each of these medicines, but they have been reported for at least one of them. There are some similarities among these combination medicines, so many of the above side effects may occur with any of these medicines.
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.
Can treat a wide variety of symptoms for common cold
Combines three medications into one liquid for convenience
Available as a liquid
Can take with or without food
Effects last about 4 hours
Has potential for misuse
Can cause constipation
Not for long-term use
You can take Virtussin Dac with or without food. If it upsets your stomach, taking it with food might help.
When measuring your dose of Virtussin Dac, use the medication dose cup or oral syringe provided by your pharmacy. Don't use household spoons, because they aren't accurate and might cause you to take the wrong dose.
If Virtussin Dac is making you sleepy or dizzy during the day, it can affect your ability to focus, think, or react. Don't drive until you know how this medication affects you. Also, avoid alcohol while taking this medication because it can make sleepiness worse.
Stop using Virtussin Dac and contact your primary care provider if your symptoms last more than a week or come back after clearing up. Also tell them if you have a rash, fever, or headache along with your cough or stuffy nose. These might be signs that you need more medical attention.
Tell your care team about all the medications you're taking to make sure Virtussin Dac is safe for you. Don't start any new medications while taking Virtussin Dac, especially other medications with opioids, expectorants, or decongestants, without talking to your care team first. Doing so can raise your risk of overdose and severe side effects, including slowed breathing, dizziness, and sleepiness.
Don't take Virtussin Dac if you're taking a monoamine oxidase inhibitor (MAOI), such as selegiline, phenelzine (Nardil), or tranylcypromine (Parnate). This combination can cause dangerous changes to your blood pressure. If you've taken an MAOI in the last 2 weeks, don't use Virtussin Dac and contact your provider for other options to treat your allergy or common cold symptoms.
Store Virtussin Dac out of reach from children, pets, or visitors. If you don't need to take Virtussin Dac anymore, choose a medication take-back option to get rid of it safely. This lowers the risk of accidental overdose and helps prevent medication misuse.
Each 5 mL of Virtussin DAC contains 10 mg of codeine, 100 mg of guaifenesin, and 30 mg of pseudoephedrine.
Adults and children 12 years or older: The typical dose is 2 teaspoonfuls (10 mL) by mouth every 4 hours.
Children ages 6 to 11 years old: The typical dose is 1 teaspoonful (5 mL) by mouth every 4 hours, or as directe by a HCP.
Children under 6 years old: Ask your child's pediatrician.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.
Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Children younger than 2 years old
Severely slowed breathing (respiratory depression)
Severe asthma or other breathing conditions
Currently take or have taken an monoamine oxidase inhibitor (MAOI) in the last 2 weeks
Temporary relief of common cold symptoms, including:
Cough from minor throat irritations
Stuffy nose (nasal congestion)
Chest congestion
Loosen phlegm (mucus) in the lungs to make it easier to cough up
Short-term relief of cough and stuffy nose (nasal congestion)
Chest congestion
Sinus congestion and pressure
Stuffy nose
Cough
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Fiedorowicz, J. G., et al. (2004). The role of monoamine oxidase inhibitors in current psychiatric practice. Journal of Psychiatric Practice.
Johnson, D. A., et al. (1993). The pharmacology of alpha-adrenergic decongestants. Pharmacotherapy.
Lannett Company, Inc. (2019). Codeine sulfate- codeine sulfate tablet [package insert]. DailyMed.
Peechakara, B. V., et al. (2024). Codeine. StatPearls.
U.S. Food and Drug Administration. (2022). Drug disposal: Drug take back locations.
U.S. Food and Drug Administration. (2023). FDA Drug Safety Communication: FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women.
U.S. Food and Drug Administration. (2023). Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS).
United States Drug Enforcement Administration. (n.d.). The Controlled Substances Act.
Virtus Pharmaceuticals. (2022). Virtussin DAC- codeine phosphate, guaifenesin, and pseudoephedrine hydrochloride liquid [package insert]. DailyMed.
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