Ninjacof-Xg 200-8mg/5ml Liquid
WARNING: For all patients taking this drug:This drug has an opioid drug in it. Opioid drugs can put you at risk for drug use disorder. Misuse or abuse of this drug can lead to overdose and death. If you have questions, talk with your doctor.You will be watched closely to make sure you do not misuse this drug or develop drug use disorder.This drug has an opioid drug in it. Severe side effects have happened when opioid drugs were used with benzodiazepines, alcohol, marijuana or other forms of cannabis, or prescription or OTC drugs that may cause drowsiness or slowed actions. This includes slow or troubled breathing and death. Benzodiazepines include drugs like alprazolam, diazepam, and lorazepam. Benzodiazepines may be used to treat many health problems like anxiety, trouble sleeping, or seizures. If you have questions, talk with the doctor.Many drugs interact with this drug and can raise the chance of side effects like deadly breathing problems. Talk with your doctor and pharmacist to make sure it is safe to use this drug with all of your drugs.Do not take with alcohol or products that have alcohol. Unsafe and sometimes deadly effects may happen.Get medical help right away if you feel very sleepy, very dizzy, or if you pass out. Caregivers or others need to get medical help right away if the patient does not respond, does not answer or react like normal, or will not wake up.This drug may cause very bad and sometimes deadly breathing problems. Call your doctor right away if you have slow, shallow, or trouble breathing.Children:This drug is not for use in children younger than 18 years of age. The benefits of taking this drug for a cough due to allergies, a cold, or other infection do not outweigh the risks in children. If your child has been given this drug or if you have any questions, talk with your child's doctor. @ COMMON USES: It is used to thin mucus so it can be taken from the body by coughing.It is used to relieve coughing.
Drug Class
Antitussive, Expectorant
Pharmacologic Class
Opioid Analgesic/Antitussive (Codeine), Expectorant (Guaifenesin)
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Schedule V
Overview
What is this medicine?
This medicine is a combination of two drugs: guaifenesin and codeine. Guaifenesin helps to thin and loosen mucus in your lungs, making it easier to cough up. Codeine is a cough suppressant that works by calming the cough reflex in your brain. It is used to relieve cough and chest congestion caused by colds, flu, or other breathing illnesses.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food. If you experience stomach upset, taking it with food may help. Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
To ensure accurate dosing, measure liquid medications carefully using the device provided with the medication. If no device is included, ask your pharmacist for a suitable measuring tool.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding bathrooms. Keep it in a secure location where children and pets cannot access it, and where others cannot easily find it. Consider using a locked box or area to store your medication. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your doctor or pharmacist. If you have questions about disposing of your medication, consult your pharmacist, who may be aware of local drug take-back programs.
Missing a Dose
If you take this medication regularly and miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at once or take extra doses. If you take this medication as needed, do not take it more frequently than directed by your doctor.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food. If you experience stomach upset, taking it with food may help. Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
To ensure accurate dosing, measure liquid medications carefully using the device provided with the medication. If no device is included, ask your pharmacist for a suitable measuring tool.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding bathrooms. Keep it in a secure location where children and pets cannot access it, and where others cannot easily find it. Consider using a locked box or area to store your medication. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your doctor or pharmacist. If you have questions about disposing of your medication, consult your pharmacist, who may be aware of local drug take-back programs.
Missing a Dose
If you take this medication regularly and miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at once or take extra doses. If you take this medication as needed, do not take it more frequently than directed by your doctor.
Lifestyle & Tips
- Avoid alcohol while taking this medication, as it can increase drowsiness and dizziness.
- Do not drive or operate heavy machinery until you know how this medication affects you, as it can cause drowsiness and impair your ability to perform these tasks safely.
- Drink plenty of fluids (water, juice) to help loosen mucus and make it easier to cough up.
- Avoid smoking, as it can worsen cough and lung irritation.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
10 mL (200 mg guaifenesin / 8 mg codeine) orally every 4 to 6 hours as needed
Dose Range:
10 - 20 mg
Condition-Specific Dosing:
max_daily_dose:
Not to exceed 60 mL (1200 mg guaifenesin / 48 mg codeine) in 24 hours
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Contraindicated for children younger than 12 years of age; Not established for 6-12 years due to risk of respiratory depression.
Adolescent:
Not recommended for adolescents 12 to 18 years of age who are obese or have conditions such as obstructive sleep apnea or severe pulmonary disease due to increased risk of respiratory depression. If used, lowest effective dose for shortest duration.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended for guaifenesin; use with caution for codeine.
Moderate:
Use with caution; consider reduced dose and extended dosing interval for codeine.
Severe:
Use with caution; consider reduced dose and extended dosing interval for codeine. Avoid if possible.
Dialysis:
Codeine and its metabolites are dialyzable to some extent; use with caution and monitor for prolonged effects.
Hepatic Impairment:
Mild:
Use with caution for codeine.
Moderate:
Consider reduced dose and extended dosing interval for codeine.
Severe:
Consider reduced dose and extended dosing interval for codeine. Avoid if possible due to impaired metabolism and increased risk of adverse effects.
Pharmacology
Mechanism of Action
Guaifenesin acts as an expectorant by increasing the volume and decreasing the viscosity of secretions in the trachea and bronchi, thereby facilitating the removal of mucus. Codeine is an opioid agonist that acts on mu-opioid receptors in the central nervous system to produce antitussive effects by suppressing the cough reflex.
Pharmacokinetics
Absorption:
Bioavailability:
Not available (Guaifenesin: rapidly absorbed; Codeine: well absorbed orally)
Tmax:
Guaifenesin: ~1 hour; Codeine: ~0.5-1 hour
FoodEffect:
Food may slightly delay absorption but does not significantly affect extent of absorption.
Distribution:
Vd:
Guaifenesin: Not available; Codeine: ~2.5 L/kg
ProteinBinding:
Guaifenesin: Not available; Codeine: ~7-25%
CnssPenetration:
Yes (Codeine), Limited (Guaifenesin)
Elimination:
HalfLife:
Guaifenesin: ~1 hour; Codeine: ~2.5-4 hours
Clearance:
Not available
ExcretionRoute:
Renal (primarily)
Unchanged:
Guaifenesin: <1%; Codeine: ~5-10%
Pharmacodynamics
OnsetOfAction:
Guaifenesin: ~30 minutes; Codeine: ~30-60 minutes
PeakEffect:
Guaifenesin: ~1 hour; Codeine: ~1-2 hours
DurationOfAction:
Guaifenesin: ~4-6 hours; Codeine: ~4-6 hours
Safety & Warnings
BLACK BOX WARNING
Risk of respiratory depression and death in children: Codeine is contraindicated in children younger than 12 years of age and in adolescents 12 to 18 years of age following tonsillectomy and/or adenoidectomy. Life-threatening respiratory depression and death have occurred in children who received codeine, most often after tonsillectomy and/or adenoidectomy, and had evidence of being ultra-rapid metabolizers of codeine due to a CYP2D6 polymorphism. Risk of respiratory depression and death in ultra-rapid metabolizers of codeine: Individuals who are ultra-rapid metabolizers of codeine due to a CYP2D6 polymorphism may convert codeine to morphine more rapidly and completely than other people. This rapid conversion results in higher than normal morphine levels in the blood, which can lead to life-threatening respiratory depression or death. Even in individuals who are not ultra-rapid metabolizers, codeine can cause life-threatening respiratory depression. Concomitant use with benzodiazepines or other CNS depressants: Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Opioid addiction, abuse, and misuse: The use of codeine exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing and monitor all patients receiving codeine for signs of addiction, abuse, and misuse.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Severe dizziness or fainting
Chest pain or pressure, rapid heartbeat, or irregular heartbeat
Breathing difficulties, slow breathing, or shallow breathing
Noisy breathing
Sleep apnea (breathing problems during sleep)
Confusion
Hallucinations (seeing or hearing things that are not there)
Mood changes
Seizures
Severe headache
Urination difficulties
Shakiness
Changes in vision
Severe constipation or stomach pain, which may indicate a serious bowel problem
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical help:
Constipation
Upset stomach or vomiting
Dizziness, drowsiness, fatigue, or weakness
* Excessive sweating
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Severe dizziness or fainting
Chest pain or pressure, rapid heartbeat, or irregular heartbeat
Breathing difficulties, slow breathing, or shallow breathing
Noisy breathing
Sleep apnea (breathing problems during sleep)
Confusion
Hallucinations (seeing or hearing things that are not there)
Mood changes
Seizures
Severe headache
Urination difficulties
Shakiness
Changes in vision
Severe constipation or stomach pain, which may indicate a serious bowel problem
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical help:
Constipation
Upset stomach or vomiting
Dizziness, drowsiness, fatigue, or weakness
* Excessive sweating
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Slow, shallow, or difficult breathing
- Extreme drowsiness or dizziness
- Confusion or disorientation
- Blue-tinged lips or skin
- Severe constipation or abdominal pain
- Signs of an allergic reaction (rash, hives, swelling of face/lips/tongue, difficulty breathing)
- Signs of serotonin syndrome (agitation, hallucinations, rapid heart rate, fever, sweating, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
Existing health conditions, including:
+ Respiratory problems like asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel obstruction or narrowing
Respiratory issues, such as:
+ A cough producing excessive mucus
+ A chronic cough caused by smoking or exposure to smoke
+ Lung conditions like asthma or emphysema
Recent use (within the last 14 days) of certain medications for depression or Parkinson's disease, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure
Current use of any of the following medications: buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
If your doctor has informed you that you are a rapid metabolizer of certain medications
* If you are breast-feeding, as you should not breast-feed while taking this medication
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use. Never start, stop, or adjust the dosage of any medication without consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
Existing health conditions, including:
+ Respiratory problems like asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel obstruction or narrowing
Respiratory issues, such as:
+ A cough producing excessive mucus
+ A chronic cough caused by smoking or exposure to smoke
+ Lung conditions like asthma or emphysema
Recent use (within the last 14 days) of certain medications for depression or Parkinson's disease, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure
Current use of any of the following medications: buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
If your doctor has informed you that you are a rapid metabolizer of certain medications
* If you are breast-feeding, as you should not breast-feed while taking this medication
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use. Never start, stop, or adjust the dosage of any medication without consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Adhere strictly to the dosage instructions provided by your doctor, as taking more than prescribed may increase the risk of severe side effects. Do not exceed the recommended treatment duration, and only use this medication for the length of time specified by your doctor.
Until you understand how this medication affects you, avoid operating a vehicle or engaging in activities that require alertness. To minimize the risk of dizziness or fainting, rise slowly from a seated or lying position, and exercise caution when navigating stairs.
Long-term use of this medication can lead to dependence. If you have been taking this medication regularly and stop abruptly, you may experience withdrawal symptoms. Do not discontinue use without consulting your doctor, and report any adverse effects to your doctor promptly.
Do not combine this medication with other potent pain medications or use a pain patch without first discussing it with your doctor. This medication may interfere with certain laboratory tests, so inform all your healthcare providers and laboratory personnel that you are taking this medication.
Keep this medication out of reach of children, as accidental ingestion can be fatal. If a child accidentally ingests this medication, seek immediate medical attention.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Children, particularly those with pre-existing breathing problems, are at a higher risk of severe side effects, including life-threatening respiratory issues. Consult your doctor to discuss the potential risks.
Using this medication during pregnancy can harm the unborn baby. If you become pregnant or are already pregnant while taking this medication, notify your doctor immediately. Prolonged use during pregnancy may lead to withdrawal symptoms in the newborn, which can be life-threatening if left untreated.
Until you understand how this medication affects you, avoid operating a vehicle or engaging in activities that require alertness. To minimize the risk of dizziness or fainting, rise slowly from a seated or lying position, and exercise caution when navigating stairs.
Long-term use of this medication can lead to dependence. If you have been taking this medication regularly and stop abruptly, you may experience withdrawal symptoms. Do not discontinue use without consulting your doctor, and report any adverse effects to your doctor promptly.
Do not combine this medication with other potent pain medications or use a pain patch without first discussing it with your doctor. This medication may interfere with certain laboratory tests, so inform all your healthcare providers and laboratory personnel that you are taking this medication.
Keep this medication out of reach of children, as accidental ingestion can be fatal. If a child accidentally ingests this medication, seek immediate medical attention.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Children, particularly those with pre-existing breathing problems, are at a higher risk of severe side effects, including life-threatening respiratory issues. Consult your doctor to discuss the potential risks.
Using this medication during pregnancy can harm the unborn baby. If you become pregnant or are already pregnant while taking this medication, notify your doctor immediately. Prolonged use during pregnancy may lead to withdrawal symptoms in the newborn, which can be life-threatening if left untreated.
Overdose Information
Overdose Symptoms:
- Slowed or stopped breathing
- Extreme drowsiness or unresponsiveness
- Pinpoint pupils
- Cold, clammy skin
- Limp muscles
- Loss of consciousness
- Blue discoloration of lips or fingernails
What to Do:
Seek immediate emergency medical attention. Call 911 or Poison Control at 1-800-222-1222. Naloxone may be administered by emergency personnel.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (within 14 days)
Major Interactions
- CNS depressants (e.g., alcohol, benzodiazepines, other opioids, sedatives, hypnotics, tricyclic antidepressants, phenothiazines, general anesthetics, muscle relaxants)
- CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine, bupropion)
- CYP2D6 ultra-rapid metabolizers (increased risk of toxicity from morphine)
Moderate Interactions
- Anticholinergic drugs (increased risk of urinary retention and/or severe constipation)
- Serotonergic drugs (e.g., SSRIs, SNRIs, triptans) (potential for serotonin syndrome)
- P-glycoprotein inhibitors (e.g., quinidine, verapamil) (may increase codeine levels)
- Cimetidine (may inhibit codeine metabolism)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Respiratory rate and depth
Rationale: To assess baseline respiratory function before initiating opioid therapy.
Timing: Prior to first dose
Cough characteristics (frequency, severity, sputum production)
Rationale: To establish baseline and monitor treatment efficacy.
Timing: Prior to first dose
Level of consciousness/sedation
Rationale: To assess baseline neurological status and risk of CNS depression.
Timing: Prior to first dose
Routine Monitoring
Respiratory rate and depth
Frequency: Periodically during therapy, especially after dose adjustments or with concomitant CNS depressants.
Target: Normal for age; >12 breaths/min for adults
Action Threshold: <10 breaths/min or significant decrease from baseline; signs of respiratory distress
Level of consciousness/sedation
Frequency: Periodically during therapy.
Target: Alert and oriented, or mild sedation if expected.
Action Threshold: Excessive somnolence, difficulty arousing, confusion
Cough relief and sputum characteristics
Frequency: Daily or as needed.
Target: Reduced cough frequency and severity, easier expectoration.
Action Threshold: No improvement in symptoms, worsening cough, or difficulty clearing secretions
Bowel function
Frequency: Daily
Target: Regular bowel movements
Action Threshold: Constipation, abdominal pain, or distension
Symptom Monitoring
- Signs of respiratory depression (slow, shallow breathing, blue lips/skin)
- Excessive sedation or drowsiness
- Dizziness or lightheadedness
- Nausea or vomiting
- Constipation
- Allergic reactions (rash, itching, swelling)
- Signs of serotonin syndrome (agitation, hallucinations, rapid heart rate, fever, sweating, muscle rigidity, twitching, loss of coordination, nausea, vomiting, diarrhea)
Special Patient Groups
Pregnancy
Use during pregnancy is generally not recommended, especially in the third trimester or for prolonged periods, due to the risk of neonatal opioid withdrawal syndrome and respiratory depression in the infant. Codeine is Pregnancy Category C (risk cannot be ruled out).
Trimester-Specific Risks:
First Trimester:
Limited data, but potential for congenital malformations with opioid exposure.
Second Trimester:
Risk of neonatal opioid withdrawal syndrome increases with prolonged use.
Third Trimester:
Increased risk of neonatal opioid withdrawal syndrome, respiratory depression, and other adverse effects in the newborn if used near term.
Lactation
Not recommended during breastfeeding due to the risk of serious adverse reactions, including respiratory depression and death, in breastfed infants. Codeine is metabolized to morphine, which can be excreted in breast milk. Mothers who are ultra-rapid metabolizers of codeine may produce higher levels of morphine in breast milk.
Infant Risk:
High risk of respiratory depression, sedation, poor feeding, and death, especially in infants of mothers who are ultra-rapid metabolizers of codeine.
Pediatric Use
Contraindicated in children younger than 12 years of age. Not recommended for adolescents 12 to 18 years of age who are obese or have conditions such as obstructive sleep apnea or severe pulmonary disease due to increased risk of respiratory depression. Use of codeine-containing products for cough and cold in children is generally discouraged due to serious risks.
Geriatric Use
Elderly patients may be more sensitive to the respiratory depressant and CNS effects of codeine. Start with lower doses and monitor closely for sedation, respiratory depression, and constipation. Renal and hepatic impairment are more common in the elderly, requiring dose adjustments.
Clinical Information
Clinical Pearls
- Educate patients and caregivers about the serious risks of respiratory depression, especially in children and ultra-rapid metabolizers.
- Emphasize the importance of avoiding alcohol and other CNS depressants while taking this medication.
- Advise patients to drink plenty of fluids to maximize the expectorant effect of guaifenesin.
- Monitor for signs of constipation, a common side effect of codeine, and recommend appropriate management (e.g., increased fiber, fluids, laxatives if needed).
- Due to the opioid component, assess for risk factors for addiction, abuse, and misuse prior to prescribing and monitor during therapy.
- This combination product is intended for short-term use for acute cough and congestion; prolonged use should be avoided.
Alternative Therapies
- Single-ingredient guaifenesin (e.g., Mucinex)
- Single-ingredient dextromethorphan (e.g., Delsym)
- Non-pharmacological measures for cough (e.g., humidifiers, honey, saline nasal spray)
- Other antitussives (e.g., benzonatate)
- Other expectorants (e.g., saline nebulization)
Cost & Coverage
Average Cost:
Price varies widely per 120 mL or 480 mL bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often requires prior authorization for codeine-containing products)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.