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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Pulsatilla Pratensis Whole,oyster Shell Calcium Carbonate, Crude,goldenseal And Potassium Dichromate
Brand Name
4 Kids Stuffy Nose And Sinus
Generic Name
Pulsatilla Pratensis Whole,oyster Shell Calcium Carbonate, Crude,goldenseal And Potassium Dichromate
Active Ingredient
GoldensealCategory
Non-Standardized Food Allergenic Extract [EPC]
Variants
1
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 6 [hp_X]/1 | TABLET | ORAL | 54973-3406 |
Detailed information about 4 Kids Stuffy Nose And Sinus
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for 4 Kids Stuffy Nose And Sinus, you must consult a qualified healthcare professional.
Goldenseal is a botanical agent classified primarily as a Non-Standardized Food Allergenic Extract [EPC]. It exhibits complex pharmacological activity, including roles as an estrogen and androgen receptor agonist and an acetylcholine release inhibitor.
Dosage for Goldenseal varies significantly based on the intended use and the form of the extract.
Goldenseal is generally not recommended for use in infants or young children. There is a significant risk of kernicterus (a type of brain damage) in newborns due to berberine's ability to displace bilirubin from albumin. For older children, use must be strictly supervised by a pediatrician, though many clinicians advise avoiding it entirely in the pediatric population.
Caution is advised in patients with kidney disease. While specific dose adjustments are not standardized, reduced clearance may lead to alkaloid accumulation.
Because Goldenseal is a potent inhibitor of hepatic enzymes (CYP3A4), patients with liver impairment should use this agent with extreme caution or avoid it, as it may exacerbate liver stress or lead to unpredictable drug levels.
Older adults should start at the lowest possible dose due to a higher prevalence of polypharmacy and age-related declines in hepatic and renal function.
If you miss a dose, take it as soon as you remember. If it is nearly time for your next dose, skip the missed dose and resume your regular schedule. Do not double the dose to catch up.
Signs of Goldenseal overdose may include severe nausea, vomiting, diarrhea, respiratory depression, and bradycardia (slow heart rate). In case of suspected overdose, contact a poison control center or seek emergency medical attention immediately.
> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose without medical guidance.
> Warning: Stop taking Goldenseal and call your doctor immediately if you experience any of these:
Prolonged use of Goldenseal may lead to an imbalance in gut microbiota or reduced absorption of B vitamins. There is also concern regarding the cumulative effect on liver enzymes, which can permanently alter the metabolism of other essential medications.
No FDA black box warnings are currently issued for Goldenseal. However, clinical literature strongly warns against its use in neonates due to the risk of brain damage from bilirubin displacement.
Report any unusual symptoms to your healthcare provider.
Goldenseal is a potent biological agent and should not be treated as a "mild" herbal supplement. Its ability to inhibit major metabolic enzymes means it can dangerously increase the levels of other prescription drugs in your system.
No FDA black box warnings for Goldenseal.
If using Goldenseal long-term or at high doses, your healthcare provider may require:
Goldenseal may cause dizziness or CNS stimulation in some users. Ensure you know how you react to this agent before driving or operating heavy machinery.
Alcohol should be avoided or minimized, as it may exacerbate gastrointestinal side effects and increase the metabolic load on the liver.
There is no known withdrawal syndrome associated with Goldenseal, but it is recommended to taper off high doses to avoid gastrointestinal rebound effects.
> Important: Discuss all your medical conditions with your healthcare provider before starting Goldenseal.
Goldenseal may interfere with urine tests for illicit drugs (historically used to mask results, though modern tests are generally resistant) and may falsely elevate liver enzyme readings in certain assays.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking.
Patients allergic to other berberine-containing plants (such as Oregon Grape or Barberry) may experience cross-allergic reactions when using Goldenseal.
> Important: Your healthcare provider will evaluate your complete medical history before prescribing Goldenseal.
FDA Category: Avoid Use. Goldenseal is contraindicated during pregnancy. It contains alkaloids that can cross the placenta and stimulate uterine contractions, potentially leading to miscarriage or preterm birth. Furthermore, the risk of neonatal jaundice and kernicterus is significant.
Goldenseal is not recommended for nursing mothers. Active alkaloids are excreted into breast milk and can be ingested by the infant, posing a risk of brain damage and other toxicities in the newborn.
Goldenseal is generally considered unsafe for infants. For older children, there is insufficient data to establish a safe dose, and its use is typically discouraged by pediatric associations.
Elderly patients are at an increased risk for drug interactions. Clinical monitoring should focus on renal function and potential interactions with cardiovascular or blood-thinning medications.
Use with caution. There are no specific GFR-based dosing guidelines, but patients with advanced renal disease should avoid high doses due to the risk of alkaloid accumulation.
Goldenseal should be avoided in patients with significant hepatic impairment (Child-Pugh Class B or C) due to its profound effect on the CYP3A4 enzyme system and the potential for hepatotoxicity.
> Important: Special populations require individualized medical assessment.
Goldenseal's primary alkaloids, berberine and hydrastine, act as multi-target ligands. Berberine activates the AMP-activated protein kinase (AMPK) pathway, which influences glucose and lipid metabolism. As an Estrogen and Androgen Receptor Agonist, it modulates gene expression in hormone-sensitive tissues. Its role as an Acetylcholine Release Inhibitor and Neuromuscular Blocker involves interference with cholinergic transmission at the synaptic cleft.
Goldenseal exhibits a dose-dependent effect on smooth muscle and inflammatory mediators. Its anti-inflammatory action is mediated through the inhibition of COX-2 and various cytokines. The onset of systemic effects typically occurs within 1–2 hours of oral administration, with a duration of effect lasting approximately 6–8 hours.
| Parameter | Value |
|---|---|
| Bioavailability | < 5% (Berberine) |
| Protein Binding | ~90% |
| Half-life | 3 - 6 hours |
| Tmax | 1 - 4 hours |
| Metabolism | Hepatic (CYP3A4, CYP2D6) |
| Excretion | Renal (trace), Fecal (primary) |
Goldenseal is categorized as a Non-Standardized Plant Allergenic Extract [EPC] and a botanical alkaloid complex. It shares therapeutic similarities with other berberine-containing plants like Berberis aristata.
Common questions about 4 Kids Stuffy Nose And Sinus
Goldenseal is primarily used as a non-standardized allergenic extract for diagnostic testing and immunotherapy. In traditional and complementary medicine, it is often used for its antimicrobial and anti-inflammatory properties, particularly for mucous membrane issues like those found in the digestive or respiratory tracts. Some clinical data suggests it may act as a mild hormone modulator due to its estrogenic and androgenic receptor activity. However, it is most recognized in modern pharmacology for its potent ability to inhibit liver enzymes, which affects how other drugs are processed. Always consult a healthcare provider before using it for any therapeutic purpose.
The most frequently reported side effects include gastrointestinal issues such as nausea, stomach cramps, and diarrhea. Some users may experience a bitter taste in the mouth or localized irritation if using liquid extracts. Less commonly, individuals might notice increased sensitivity to sunlight (photosensitivity) or mild nervousness. While these are often mild, they can persist if the supplement is taken for more than two weeks. If side effects become severe or if you notice yellowing of the skin, you should stop use and contact a doctor immediately.
It is generally advised to avoid or strictly limit alcohol consumption while taking Goldenseal. Alcohol can increase the risk of gastrointestinal irritation and may place additional stress on the liver, which is already processing Goldenseal's potent alkaloids. Since Goldenseal inhibits the CYP3A4 enzyme, it may also alter the way alcohol or its metabolites are cleared from the body. Combining the two could lead to increased dizziness or nausea. Discuss your alcohol intake with your doctor to ensure safety.
No, Goldenseal is considered unsafe and is contraindicated during pregnancy. It contains berberine, which can cause uterine contractions and potentially lead to miscarriage or preterm labor. Additionally, berberine can cross the placenta and has been linked to a serious type of brain damage in newborns called kernicterus. This occurs because the compound displaces bilirubin from proteins in the blood. Expectant mothers should avoid all forms of Goldenseal to protect the health of the fetus.
The time it takes for Goldenseal to work depends on the condition being treated and the form used. For acute gastrointestinal or mucous membrane issues, some individuals may notice improvement within 24 to 48 hours of starting oral use. However, its effects on metabolism and hormone receptors may take several days of consistent use to become apparent. If used as an allergenic extract for immunotherapy, the process is much slower, often taking weeks or months to modulate the immune response. Your healthcare provider can give you a more specific timeline based on your treatment plan.
Yes, Goldenseal can generally be stopped suddenly without the risk of a traditional withdrawal syndrome. Unlike some prescription medications, it does not typically cause physical dependence. However, if you have been taking high doses for an extended period, you might experience a temporary return of the symptoms you were treating. It is always best to inform your healthcare provider before stopping any supplement, especially if it was part of a managed treatment plan. They may suggest a gradual reduction to monitor your body's response.
If you miss a dose of Goldenseal, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed one and continue with your regular timing. You should never take two doses at once to make up for a missed one, as this increases the risk of alkaloid toxicity and side effects. Maintaining a consistent schedule helps keep stable levels of the active constituents in your system. If you miss multiple doses, consult your healthcare provider for guidance.
There is currently no strong clinical evidence to suggest that Goldenseal causes weight gain. In fact, some research into its primary alkaloid, berberine, suggests it may support metabolic health and potentially aid in weight management by activating the AMPK pathway. However, because Goldenseal can interact with hormones like estrogen and progesterone, some individuals might experience minor fluid retention or changes in appetite. Any significant or rapid weight change while taking this supplement should be discussed with a medical professional. It is not approved as a weight-loss medication.
Goldenseal has a very high potential for drug interactions and should be used with extreme caution if you are taking other medications. It is a potent inhibitor of the CYP3A4 and CYP2D6 enzymes, which are responsible for breaking down about 50% of all prescription drugs. This means Goldenseal can cause other medications, such as cyclosporine or certain blood thinners, to build up to dangerous levels in your blood. You must provide your doctor with a full list of all prescriptions, over-the-counter drugs, and supplements before starting Goldenseal. Monitoring and dose adjustments of your other medications may be necessary.
Goldenseal is a natural botanical product and is not sold as a 'generic' in the way prescription drugs are. Instead, it is available from many different manufacturers as a dietary supplement or as a non-standardized allergenic extract. When purchasing, look for products that are standardized to a specific percentage of alkaloids, such as 5% berberine, to ensure consistency. Because supplements are not regulated as strictly as prescription drugs, choosing a reputable brand that uses third-party testing is important. Your pharmacist can help you select a high-quality product.
Other drugs with the same active ingredient (Goldenseal)