Supress-DX Ped Drops 30ml

Manufacturer KRAMER Active Ingredient Guaifenesin, Dextromethorphan, and Phenylephrine Liquid(gwye FEN e sin, deks troe meth OR fan, & fen il EF rin) Pronunciation gwye FEN e sin, deks troe meth OR fan, & 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
Cough and Cold Preparation
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Pharmacologic Class
Expectorant; Antitussive; Alpha-Adrenergic Agonist (Decongestant)
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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 medicine is a liquid combination used to help relieve cough and nasal congestion 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 stuffy noses by shrinking blood vessels in the nasal passages.
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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 it causes stomach upset, take it with food to help minimize discomfort. Drink plenty of non-caffeinated fluids, unless your doctor advises you to limit your fluid intake.

When taking a liquid dose, measure it carefully using the device that comes with the medication. If no device is provided, ask your pharmacist for a measuring tool to ensure accurate dosing.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of 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 have questions about disposing of your medication, consult with your pharmacist, who may be aware of drug take-back programs in your area.

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 dose, skip the missed dose and resume your regular 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.
  • Get adequate rest.
  • Avoid irritants like smoke or allergens that can worsen cough or congestion.
  • Use a humidifier to help soothe irritated airways.

Dosing & Administration

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Adult Dosing

Standard Dose: Not typically used in adults; adult formulations available with higher concentrations.
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Pediatric Dosing

Neonatal: Not established; generally contraindicated.
Infant: Not established for infants under 6 months; consult physician for use in children under 2 years. Dosing is typically weight-based or age-based, e.g., 1.25 mL to 2.5 mL every 4 hours as directed by a healthcare professional, depending on product concentration and child's age/weight.
Child: Typically 2.5 mL to 5 mL every 4 hours as needed, not to exceed 6 doses in 24 hours. Specific dosing depends on product concentration (e.g., Guaifenesin 100 mg/5mL, Dextromethorphan 10 mg/5mL, Phenylephrine 5 mg/5mL) and child's age (e.g., 6-12 years). Always follow product label instructions.
Adolescent: Typically 5 mL to 10 mL every 4 hours as needed, not to exceed 6 doses in 24 hours. Specific dosing depends on product concentration. May transition to adult formulations if appropriate.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended; use with caution.
Moderate: Use with caution; consider reduced frequency or dose due to potential accumulation of metabolites.
Severe: Use with caution; consider reduced frequency or dose due to potential accumulation of metabolites. Avoid if possible.
Dialysis: Not well-studied; avoid or use with extreme caution and close monitoring.

Hepatic Impairment:

Mild: No specific adjustment recommended; use with caution.
Moderate: Use with caution; consider reduced frequency or dose, especially for dextromethorphan and phenylephrine due to hepatic metabolism.
Severe: Use with caution; consider reduced frequency or dose, especially for dextromethorphan and phenylephrine due to hepatic metabolism. Avoid if possible.
Confidence: Medium

Pharmacology

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Mechanism of Action

Guaifenesin acts as an expectorant by increasing the volume and decreasing the viscosity of respiratory tract secretions, facilitating their removal. Dextromethorphan is an antitussive that acts centrally on the cough center in the medulla, elevating the cough threshold. Phenylephrine is a direct-acting alpha-1 adrenergic agonist that causes vasoconstriction in the nasal mucosa, leading to reduced swelling and congestion.
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Pharmacokinetics

Absorption:

Bioavailability: Guaifenesin: Rapidly absorbed; Dextromethorphan: Rapidly absorbed; Phenylephrine: Low oral bioavailability (~38%) due to extensive first-pass metabolism.
Tmax: Guaifenesin: ~1 hour; Dextromethorphan: ~2 hours; Phenylephrine: ~1-2 hours.
FoodEffect: Not significantly affected by food for absorption, but may delay Tmax.

Distribution:

Vd: Guaifenesin: Not well-established; Dextromethorphan: Large Vd; Phenylephrine: Not well-established.
ProteinBinding: Guaifenesin: Not significant; Dextromethorphan: ~60-70%; Phenylephrine: Not significant.
CnssPenetration: Guaifenesin: Limited; Dextromethorphan: Yes (central action); Phenylephrine: Limited (peripheral action primarily).

Elimination:

HalfLife: Guaifenesin: ~1 hour; Dextromethorphan: 2-4 hours (parent), 15-20 hours (dextrorphan); Phenylephrine: 2-3 hours.
Clearance: Not precisely quantified for combination.
ExcretionRoute: Renal (primarily metabolites).
Unchanged: Guaifenesin: <1%; Dextromethorphan: <1%; Phenylephrine: <1%.
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Pharmacodynamics

OnsetOfAction: Guaifenesin: ~30 minutes; Dextromethorphan: ~15-30 minutes; Phenylephrine: ~15-30 minutes.
PeakEffect: Guaifenesin: ~1 hour; Dextromethorphan: ~2 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

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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ 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. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor for guidance:

Dizziness
Feeling nervous and excitable
Trouble sleeping

Note: This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, you can also contact your doctor.

Reporting Side Effects

You can 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 more than 7 days, comes back, or occurs with fever, rash, or persistent headache.
  • Nasal congestion that lasts more than 7 days or worsens.
  • Nervousness, dizziness, or sleeplessness.
  • Significant increase in blood pressure or heart rate.
  • Signs of an allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, difficulty 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 persistent 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 dose 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.
When considering this medication for a child, note that different brands may be suitable for different age groups. Therefore, it is crucial to consult with your doctor before administering this drug to a child.
If you are pregnant, planning to become pregnant, or are breastfeeding, you must discuss this with your doctor. This conversation will help weigh the benefits and risks of taking this medication to ensure the best outcome for both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Drowsiness, dizziness, confusion, agitation, hallucinations (especially with dextromethorphan).
  • Nausea, vomiting, stomach pain.
  • Rapid heart rate, palpitations, high blood pressure (with phenylephrine).
  • Tremors, seizures.
  • Difficulty breathing, shallow breathing.
  • Urinary retention.

What to Do:

Seek immediate medical attention. Call 911 or Poison Control (1-800-222-1222). Bring the product container with you.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of stopping MAOIs due to risk of hypertensive crisis and serotonin syndrome with phenylephrine and dextromethorphan, respectively).
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Major Interactions

  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, linezolid, methylene blue) with dextromethorphan (risk of serotonin syndrome).
  • Other sympathomimetics (e.g., pseudoephedrine, ephedrine, stimulants) with phenylephrine (additive cardiovascular effects, increased blood pressure, heart rate).
  • Beta-blockers (e.g., propranolol) with phenylephrine (may increase blood pressure due to unopposed alpha-adrenergic effects).
  • Antihypertensive drugs (e.g., ACE inhibitors, ARBs, diuretics) with phenylephrine (may reduce antihypertensive effect).
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Moderate Interactions

  • Alcohol and other CNS depressants (e.g., sedatives, hypnotics, anxiolytics) with dextromethorphan (additive CNS depression, drowsiness).
  • CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine) with dextromethorphan (may increase dextromethorphan levels and adverse effects).
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Minor Interactions

  • None commonly cited for guaifenesin.

Monitoring

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Symptom Monitoring

  • Effectiveness in reducing cough and nasal congestion.
  • Presence of adverse effects such as drowsiness, dizziness, nausea, vomiting, headache, nervousness, insomnia, increased heart rate, or elevated blood pressure.
  • Signs of allergic reaction (rash, itching, swelling).

Special Patient Groups

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Pregnancy

Generally, this combination is not recommended during pregnancy unless clearly necessary and advised by a healthcare provider. All three components are Category C, meaning animal studies have shown an adverse effect on the fetus, but there are no adequate and well-controlled studies in humans. Use only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Avoid if possible due to limited data and potential for teratogenicity with sympathomimetics.
Second Trimester: Use with caution; generally considered safer than first trimester, but still weigh risks vs. benefits.
Third Trimester: Use with caution; phenylephrine may cause uterine vasoconstriction and fetal hypoxia. Dextromethorphan may cause neonatal respiratory depression if used close to delivery.
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Lactation

Use with caution. Guaifenesin is considered L3 (moderately safe), Dextromethorphan is L2 (safer), and Phenylephrine is L3 (moderately safe). Small amounts of these drugs may pass into breast milk. Monitor the infant for drowsiness, irritability, or changes in feeding patterns. Consult a healthcare provider before use.

Infant Risk: Low to moderate risk. Potential for infant drowsiness, irritability, or cardiovascular effects (with phenylephrine).
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Pediatric Use

This product is specifically formulated for pediatric use. However, extreme caution is advised, especially in children under 2 years of age, where cough and cold medicines are generally not recommended due to lack of efficacy and potential for serious side effects, including overdose. Always use an accurate measuring device (e.g., oral syringe, dosing cup) and never use household spoons. Adhere strictly to age- and weight-appropriate dosing guidelines on the product label or as directed by a physician. Do not exceed recommended doses or frequency.

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Geriatric Use

Use with caution in elderly patients due to increased sensitivity to adverse effects, particularly from phenylephrine (e.g., increased blood pressure, heart rate, CNS stimulation) and dextromethorphan (e.g., drowsiness, dizziness). Patients with pre-existing cardiovascular conditions, glaucoma, or prostate enlargement should use with medical supervision.

Clinical Information

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Clinical Pearls

  • This product is for symptomatic relief only and does not treat the underlying cause of cough or congestion.
  • Always use the provided measuring device to ensure accurate dosing, especially in children.
  • Educate parents/caregivers on the importance of not exceeding recommended doses and avoiding combination with other cough/cold products containing similar ingredients.
  • Advise patients to stay well-hydrated to help with mucus thinning.
  • Counsel on potential for drowsiness (dextromethorphan) and stimulant effects (phenylephrine) and to avoid activities requiring mental alertness until effects are known.
  • Phenylephrine has poor oral bioavailability and is generally less effective as an oral decongestant compared to pseudoephedrine, but it is available OTC without restriction.
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Alternative Therapies

  • Single-ingredient expectorants (e.g., guaifenesin)
  • Single-ingredient antitussives (e.g., dextromethorphan, benzonatate)
  • Single-ingredient decongestants (e.g., pseudoephedrine, phenylephrine nasal spray)
  • Non-pharmacological treatments (e.g., saline nasal sprays, humidifiers, honey for cough in children >1 year, rest, fluids).
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Cost & Coverage

Average Cost: Variable, typically $5-$15 per 30ml bottle
Generic Available: Yes
Insurance Coverage: Not typically covered by insurance as an OTC product; may be eligible for FSA/HSA.
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 this 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.