Each 1 mL serving contains: Arctium Lappa 1:1 extract (DHE: 0.517 grams, 60% ethanol, 40% purified water) • Rheum Palmatum 1:4 extract (DHE: 0.005625 grams, 41% ehtanol, 59% purified water) • Rumex Acetosella 1:4 extract (DHE: 0.09187 grams, 41% ethanol, 59% purified water) 0.3675 mL • Ulmus rubra 1:4.5 extract (DHE: 0.020554 grams, 31.1% ethanol, 68.9% purified water) 0.0925 mL. Other Ingredients: Alcohol, Purified Water.
Brand name products often contain multiple ingredients. To read detailed information about each ingredient, click on the link for the individual ingredient shown above.
In 2004, Canada began regulating natural medicines as a category of products separate from foods or drugs. These products are officially recognized as "Natural Health Products." These products include vitamins, minerals, herbal preparations, homeopathic products, probiotics, fatty acids, amino acids, and other naturally derived supplements.
In order to be marketed in Canada, natural health products must be licensed. In order to be licensed in Canada, manufacturers must submit applications to Health Canada including information about uses, formulation, dosing, safety, and efficacy.
Products can be licensed based on several criteria. Some products are licensed based on historical or traditional uses. For example, if an herbal product has a history of traditional use, then that product may be acceptable for licensure. In this case, no reliable scientific evidence is required for approval.
For products with non-traditional uses, some level of scientific evidence may be required to support claimed uses. However, a high level of evidence is not necessarily required. Acceptable sources of evidence include at least one well-designed, randomized, controlled trial; well-designed, non-randomized trials; cohort and case control studies; or expert opinion reports.
Finished products licensed by Health Canada must be manufactured according to Good Manufacturing Practices (GMPs) as outlined by Health Canada.
Below is general information about the effectiveness of the known ingredients contained in the product 4 Herb Formula. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product 4 Herb Formula. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
LIKELY SAFE ...when used in amounts commonly found in foods (12659,12660). Burdock root is commonly eaten as a vegetable (37422,92153,92154)
POSSIBLY SAFE ...when used topically, short-term. An emulsion containing burdock fruit extract 1.2% has been safely applied to the face twice daily for 4 weeks (37420). There is insufficient reliable information available about the safety of burdock when used orally in supplemental doses.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
POSSIBLY SAFE ...when used orally and appropriately (4,12,272,512,1740).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
Slippery elm bark has historically been inserted into the cervix to induce abortion. As a result, slippery elm has been reported in some sources to have abortifacient activity. However, there is no reliable information available about whether slippery elm has abortifacient activity when taken orally.
POSSIBLY SAFE ...when used orally in amounts commonly found in foods. There is insufficient reliable information available about the safety of sorrel used in medicinal amounts.
POSSIBLY UNSAFE ...when used orally in large amounts. The oxalate content may cause serious adverse effects, including damage to the kidneys, liver, and gastrointestinal tract (71314,75138,94019).
PREGNANCY AND LACTATION: POSSIBLY SAFE
when used orally in amounts commonly found in foods.
There is insufficient reliable information available about the safety of sorrel used in medicinal amounts during pregnancy and lactation; avoid using.
Below is general information about the interactions of the known ingredients contained in the product 4 Herb Formula. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Theoretically, taking burdock with anticoagulant or antiplatelet drugs might increase the risk of bleeding.
 Details
In vitro research shows that lignans from burdock reduce rabbit platelet aggregation by inhibiting platelet activating factor (12619). This interaction has not been reported in humans. |
Theoretically, slippery elm may slow the absorption and reduce serum levels of oral drugs.
Details
Slippery elm inner bark contains mucilage, which may interfere with the absorption of orally administered drugs (19).
|
Theoretically, sorrel might cause additive effects and side effects when used with anticoagulant or antiplatelet drugs.
Details
In vitro, sorrel has been shown to inhibit platelet aggregation (103607). However, this effect has not been reported in humans.
|
Sorrel might reduce the effectiveness of fexofenadine by reducing its absorption from the gut.
Details
In vitro research shows that an ethanol extract of sorrel inhibits organic anion-transporting polypeptide 1A2 (OATP1A2), which transports fexofenadine from the intestine into cells. In rats, concomitant administration of sorrel extract with fexofenadine reduces oral absorption of fexofenadine and the area under the plasma concentration-time curve (AUC) (103606).
|
Sorrel might reduce the effectiveness of OATP substrates by reducing their absorption from the gut.
Details
In vitro research shows that sorrel inhibits OATP1A2 (103606). Theoretically it may inhibit other OATPs. The OATPs are expressed in the small intestine and liver and transport drugs into cells. Inhibition of OATP may reduce the bioavailability of oral drugs that are substrates of OATP.
|
Below is general information about the adverse effects of the known ingredients contained in the product 4 Herb Formula. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
General
...Orally, burdock is well tolerated when consumed as a food.
Although a thorough evaluation of safety outcomes is lacking, there has been long-standing historical use of burdock with few noted adverse effects.
Serious Adverse Effects (Rare):
All ROAs: Allergic reactions, including contact dermatitis and anaphylaxis.
Dermatologic ...Contact dermatitis has been reported secondary to burdock, especially after prolonged use of the root oil (37422). There are cases of allergic dermatitis secondary to using burdock plasters. Two males and a 14 year-old female developed erythematous and vesicular, pruritic, and exudative reactions in areas corresponding to the application of burdock root plasters (12667). Reactions occurred up to 7 days after initial use. Patch testing was positive for burdock sensitivity in all three patients and was nonreactive in matched controls.
Hematologic ...In one case report, a 38-year-old female developed immune-mediated thrombocytopenia after consuming a "cleansing" tea containing unknown amounts of burdock and yellow dock. The patient presented with bruising, mild weakness, and fatigue, which started 2-3 days after consuming the tea, and was found to have a platelet count of 5,000 per mcL. Symptoms resolved after platelet transfusion and treatment with oral dexamethasone (108971). It is unclear if these effects were caused by burdock, yellow dock, the combination, or other contributing factors.
Hepatic ...A case of idiosyncratic drug-induced liver disease (DILI) is reported in a 36-year-old female who presented with abdominal pain after 1 month of taking an herbal liver detox tea containing burdock and other ingredients. Remarkable laboratory values included elevated liver enzymes, alkaline phosphatase, and total bilirubin. The patient received a loading dose of N-acetylcysteine and was hospitalized for 12 days (112178). However, it is unclear if the adverse effect was due to burdock, other ingredients, or the combination.
Immunologic ...There is one case of anaphylactic shock secondary to eating boiled burdock. One hour after eating boiled burdock the patient presented with redness over the entire body and dyspnea. He was found to have low blood pressure and was treated with subcutaneous epinephrine 1 mg and intravenous lactated ringer's solution containing hydrocortisone 100 mg and dexamethasone 8 mg. The cause of anaphylactic shock was attributed to allergenicity to burdock based on positive skin prick test results. Previously, the patient had experienced urticaria after eating boiled burdock (12660).
Neurologic/CNS ...Anticholinergic reactions including dry mouth, dizziness, blurred vision, weakness, dilated pupils, inability to urinate, and bradycardia have been reported following the consumption of burdock products (12662,37421,37431,37434,37435). However, these anticholinergic reactions are believed result from contamination of burdock with belladonna alkaloids. Burdock itself does not contain atropine or other constituents that would be responsible for these reactions.
General ...Orally, slippery elm seems to be well tolerated. A thorough evaluation of safety outcomes with topical use of slippery elm has not been conducted.
Dermatologic ...Topically, slippery elm extracts can cause contact dermatitis. The pollen is an allergen (6). Contact dermatitis and urticaria have been reported after exposure to slippery elm or an oleoresin contained in the slippery elm bark (75131).
General
...Orally, sorrel seems to be generally well tolerated, based on limited data, mainly from studies with combination products.
Serious Adverse Effects (Rare):
Orally: Gastrointestinal irritation, kidney damage, liver necrosis.
Dermatologic ...Orally, sorrel, when used in combination with other herbs, has been reported to cause allergic skin reactions (374,379).
Gastrointestinal ...Orally, sorrel, when used in combination with other herbs, has been reported to cause gastrointestinal side effects including nausea and an unpleasant aftertaste (374,379,37419).
Hepatic ...Extensive liver necrosis with hepatic failure has been reported with the ingestion of large amounts of sorrel; this was likely due to its oxalate content (75138).
Pulmonary/Respiratory ...Environmental exposure to sorrel pollen may trigger allergic rhinitis or bronchial asthma in hypersensitive individuals, and allergic cross-sensitivity may occur in up to 19% of people who are allergic to weed pollen (75141).
Renal ...Sorrel contains oxalates; irolithiasis and nephrosis may be caused by the systemic absorption of oxalates and may result in kidney damage (71314). A case of acute tubulointerstitial nephritis (TIN) has been reported in a 12-year-old who consumed an unknown amount of wild sorrel. The patient presented with polyuria, hypophosphatemia, proteinuria, glucosuria, and hyperoxaluria. Recovery occurred after oral rehydration and electrolyte replacement. The TIN was likely due to formation of calcium oxalate crystals in the kidneys (94019).
