Pres Gen Pediatric Liquid

Manufacturer KRAMER-NOVIS Active Ingredient Guaifenesin, Dextromethorphan, and Phenylephrine Liquid(gwye FEN e sin, deks troe meth OR fan, & fen il EF rin) Pronunciation Guaifenesin (gwye FEN e sin), Dextromethorphan (deks troe meth OR fan), Phenylephrine (fen il EF rin)
It is used to treat nose stuffiness.It is used to thin mucus so it can be taken from the body by coughing.It is used to relieve coughing.
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Drug Class
Expectorant, Antitussive, Decongestant
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Pharmacologic Class
Guaiacol derivative, NMDA receptor antagonist, Alpha-1 adrenergic agonist
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Pregnancy Category
Category C
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

This medication is a liquid combination used to relieve cough, chest congestion, and nasal stuffiness caused by the common cold, flu, or other breathing illnesses. Guaifenesin helps thin and loosen mucus in the lungs, making it easier to cough up. Dextromethorphan helps to reduce the urge to cough. Phenylephrine helps to clear up stuffy nose by shrinking blood vessels in the nasal passages.
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How to Use This Medicine

Taking Your Medication Correctly

To use this medication safely and effectively, follow your doctor's instructions and read all accompanying information carefully. You can take this medication with or without food, but if it causes stomach upset, take it with food to help minimize discomfort. It's also important to drink plenty of non-caffeinated fluids, unless your doctor advises you to limit your fluid intake.

When taking the liquid form of this medication, measure your dose accurately using the provided measuring device. If one is not included, ask your pharmacist for a suitable measuring device to ensure you're taking the correct dose.

Storing and Disposing of Your Medication

Store this medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a secure, inaccessible place to prevent accidental ingestion by children and pets. 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're unsure about the best way to dispose 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's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses. If you take this medication as needed, do not take it more frequently than directed by your doctor.
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Lifestyle & Tips

  • Drink plenty of fluids (water, juice) to help loosen mucus and stay hydrated.
  • Get adequate rest.
  • Avoid irritants like smoke, dust, and allergens.
  • Use a humidifier to help soothe irritated airways.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: Dosage varies by product concentration. Typically, for a product containing Guaifenesin 100mg/5mL, Dextromethorphan 5mg/5mL, Phenylephrine 2.5mg/5mL: 10 mL (2 teaspoonfuls) every 4 hours as needed.
Dose Range: 10 - 10 mg

Condition-Specific Dosing:

maxDailyDose: Do not exceed 6 doses (60 mL) in 24 hours.
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Pediatric Dosing

Neonatal: Not established and generally not recommended.
Infant: Not established and generally not recommended for children under 4 years of age due to potential for serious side effects and lack of proven efficacy.
Child: For children 6 to under 12 years of age: Dosage varies by product concentration. Typically, for a product containing Guaifenesin 100mg/5mL, Dextromethorphan 5mg/5mL, Phenylephrine 2.5mg/5mL: 5 mL (1 teaspoonful) every 4 hours as needed. Do not exceed 6 doses (30 mL) in 24 hours. Not recommended for children under 6 years of age by many guidelines. For children 4 to under 6 years of age: Use only under direct medical supervision, if at all, and with extreme caution. Dosing is typically half of the 6-12 year old dose.
Adolescent: For children 12 years of age and over: Same as adult dosing (10 mL every 4 hours, max 60 mL/24 hours).
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Dose Adjustments

Renal Impairment:

Mild: Use with caution. No specific dose adjustment guidelines available for this combination.
Moderate: Use with caution. No specific dose adjustment guidelines available for this combination.
Severe: Use with caution; consult a physician. Accumulation of metabolites may occur.
Dialysis: Considerations: Not well-studied. Consult a physician.

Hepatic Impairment:

Mild: Use with caution. No specific dose adjustment guidelines available for this combination.
Moderate: Use with caution. Metabolism of Dextromethorphan and Phenylephrine may be impaired; consult a physician.
Severe: Use with caution; consult a physician. Metabolism of Dextromethorphan and Phenylephrine may be significantly impaired.
Confidence: Medium

Pharmacology

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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. Dextromethorphan is an antitussive that acts centrally on the cough center in the medulla oblongata to elevate the cough threshold. It is an NMDA receptor antagonist and a sigma-1 receptor agonist. Phenylephrine is a direct-acting sympathomimetic amine that primarily acts as a selective alpha-1 adrenergic agonist, causing vasoconstriction of arterioles in the nasal mucosa, leading to reduced swelling and congestion.
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Pharmacokinetics

Absorption:

Bioavailability: Guaifenesin: Rapidly absorbed. Dextromethorphan: Rapidly absorbed, extensive first-pass metabolism. Phenylephrine: Poor oral bioavailability (approx. 38%) due to extensive first-pass metabolism.
Tmax: Guaifenesin: ~1 hour. Dextromethorphan: ~2-2.5 hours. Phenylephrine: ~0.75-2 hours.
FoodEffect: Generally not significantly affected by food, but may delay absorption slightly.

Distribution:

Vd: Guaifenesin: Not well-established. Dextromethorphan: Large Vd (5-6 L/kg). Phenylephrine: Not well-established.
ProteinBinding: Guaifenesin: Not well-established. Dextromethorphan: ~60-70%. Phenylephrine: Not well-established.
CnssPenetration: Guaifenesin: Limited. Dextromethorphan: Yes (central action). Phenylephrine: Limited.

Elimination:

HalfLife: Guaifenesin: ~1 hour. Dextromethorphan: ~1.4-3.9 hours (parent drug), ~10 hours (dextrorphan). Phenylephrine: ~2-3 hours.
Clearance: Not well-established for combination.
ExcretionRoute: Guaifenesin: Renal (as metabolites). Dextromethorphan: Renal (as parent drug and metabolites). Phenylephrine: Renal (as metabolites).
Unchanged: Guaifenesin: <1%. Dextromethorphan: <1% (parent drug). Phenylephrine: <16%.
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Pharmacodynamics

OnsetOfAction: Guaifenesin: ~30 minutes. Dextromethorphan: ~15-30 minutes. Phenylephrine: ~15-30 minutes.
PeakEffect: Guaifenesin: ~1 hour. Dextromethorphan: ~2-3 hours. Phenylephrine: ~1-2 hours.
DurationOfAction: Guaifenesin: ~4-6 hours. Dextromethorphan: ~4-6 hours. Phenylephrine: ~4 hours.
Confidence: Medium

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
- 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, or swelling of the mouth, face, lips, tongue, or throat.

Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
- Dizziness
- Feeling nervous and excitable
- Trouble sleeping

Important Note: This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor for advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Cough that lasts for more than 7 days, comes back, or occurs with fever, rash, or persistent headache.
  • Nasal congestion that lasts for more than 7 days or worsens.
  • Difficulty breathing or shortness of breath.
  • Chest pain.
  • Severe dizziness, nervousness, or sleeplessness.
  • Fast or pounding heartbeat.
  • Signs of an allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing).
  • Any new or worsening symptoms.
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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. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Respiratory issues, such as a cough that produces a significant amount of mucus, a chronic cough caused by smoking or exposure to smoke, or lung conditions like asthma or emphysema.
If you have taken certain medications for depression or Parkinson's disease within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may increase the risk of severely high blood pressure.
If you are currently taking linezolid or methylene blue, as these medications can interact with this drug.

To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
* Your medical history, including any health problems you have

This information will help your doctor determine whether it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. To minimize the risk of severe side effects, do not exceed the dosage prescribed by your doctor. Adhering to the recommended treatment duration is also crucial; do not take this drug for longer than the period specified by your doctor.

If you are considering giving this medication to a child, it is important to consult with your doctor first, as different brands of this drug may be suitable for different age groups of children.

If you are pregnant, planning to become pregnant, or are breastfeeding, you must discuss this with your doctor. This conversation will help you understand the benefits and risks associated with taking this medication during these periods, allowing you to make an informed decision regarding you and your baby's health.
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Overdose Information

Overdose Symptoms:

  • Drowsiness, dizziness, confusion, agitation, hallucinations (especially with Dextromethorphan)
  • Nausea, vomiting, stomach pain
  • Rapid or irregular heartbeat, high blood pressure (with Phenylephrine)
  • Seizures
  • Difficulty breathing, shallow breathing
  • Urinary retention

What to Do:

If overdose is suspected, seek immediate medical attention or call a Poison Control Center (1-800-222-1222). Do NOT induce vomiting unless instructed by a healthcare professional.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs): Concomitant use with Dextromethorphan or Phenylephrine can lead to hypertensive crisis, hyperpyrexia, and serotonin syndrome. Avoid use within 14 days of MAOI discontinuation.
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Major Interactions

  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, linezolid, tramadol): Increased risk of serotonin syndrome with Dextromethorphan.
  • Other sympathomimetics (e.g., pseudoephedrine, ephedrine, amphetamines): Increased risk of cardiovascular effects (hypertension, tachycardia) with Phenylephrine.
  • Beta-blockers (non-selective): May increase pressor effects of Phenylephrine.
  • Tricyclic antidepressants: May potentiate pressor effects of Phenylephrine.
  • Antihypertensive drugs: Phenylephrine may reduce the effectiveness of antihypertensive medications.
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Moderate Interactions

  • CNS depressants (e.g., alcohol, sedatives, hypnotics, anxiolytics): Increased CNS depression with Dextromethorphan.
  • CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine): May increase Dextromethorphan levels and risk of adverse effects.
  • Digoxin: Phenylephrine may increase risk of arrhythmias.
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Minor Interactions

  • None specifically noted for this combination that are not covered above.

Monitoring

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Symptom Monitoring

  • Effectiveness in reducing cough and congestion
  • Changes in mucus consistency and ease of expectoration
  • Signs of adverse effects: dizziness, nervousness, insomnia, headache, nausea, vomiting, tachycardia, palpitations, increased blood pressure
  • Signs of allergic reaction (rash, itching, swelling)
  • Signs of serotonin syndrome (agitation, confusion, rapid heart rate, fever, muscle rigidity, sweating, diarrhea)
  • Duration of symptoms (if symptoms persist for more than 7 days or worsen, seek medical attention)

Special Patient Groups

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Pregnancy

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Consult a healthcare provider before use. Guaifenesin is generally considered low risk, but Dextromethorphan and Phenylephrine have limited human data and potential risks, especially in the first trimester or near term.

Trimester-Specific Risks:

First Trimester: Limited data. Phenylephrine is generally avoided due to vasoconstrictive effects. Dextromethorphan data is reassuring but not conclusive. Guaifenesin is generally considered low risk.
Second Trimester: Generally considered safer than first trimester, but still use with caution and only if clearly needed.
Third Trimester: Phenylephrine should be used with caution due to potential for uterine vasoconstriction and fetal hypoxia. Dextromethorphan and Guaifenesin are generally considered low risk.
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Lactation

L3 (Moderately Safe). Small amounts of Guaifenesin, Dextromethorphan, and Phenylephrine may pass into breast milk. Use with caution and observe infant for adverse effects (e.g., irritability, drowsiness, feeding changes). Consult a healthcare provider before use.

Infant Risk: Low to moderate. Potential for irritability, drowsiness, or mild cardiovascular effects in the infant, especially with Phenylephrine. Risk is generally low with occasional use at recommended doses.
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Pediatric Use

This product is specifically formulated for pediatric use, but it is CRITICAL to adhere to age restrictions. Not recommended for children under 4 years of age due to potential for serious side effects and lack of proven efficacy. For children 4-6 years, use only under medical supervision. Always use the provided dosing device and follow product-specific instructions carefully. Accidental overdose in young children can be serious or fatal.

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Geriatric Use

Use with caution in elderly patients due to increased sensitivity to sympathomimetic effects of Phenylephrine (e.g., increased blood pressure, heart rate, insomnia, nervousness) and potential for underlying cardiovascular conditions or prostate enlargement. Start with the lowest effective dose and monitor closely. Consult a physician, especially if taking other medications.

Clinical Information

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Clinical Pearls

  • Always use the dosing device provided with the product to ensure accurate measurement, especially for pediatric patients.
  • Educate parents/caregivers on the importance of age restrictions for cough and cold medications, particularly for children under 6 years old.
  • Advise patients that this medication treats symptoms but does not cure the underlying cause of the cold or flu.
  • Encourage non-pharmacological measures like hydration, rest, and humidifiers alongside medication.
  • Warn about potential for drowsiness (Dextromethorphan) or stimulation/insomnia (Phenylephrine) and advise caution with driving or operating machinery.
  • Counsel patients to avoid taking other medications containing similar active ingredients to prevent accidental overdose.
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Alternative Therapies

  • Single-ingredient Guaifenesin (for expectorant effect)
  • Single-ingredient Dextromethorphan (for cough suppression)
  • Single-ingredient Phenylephrine or Pseudoephedrine (for decongestion)
  • Saline nasal sprays (for congestion)
  • Honey (for cough in children >1 year)
  • Vapor rub
  • Warm fluids, lozenges
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Cost & Coverage

Average Cost: Varies widely by retailer and specific product formulation (generic OTC liquid) per bottle
Generic Available: Yes
Insurance Coverage: Generally not covered by prescription insurance as it is an over-the-counter (OTC) medication. May be eligible for FSA/HSA reimbursement.
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General Drug Facts

If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about your medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.