Ingredients | Amount Per Serving |
---|---|
Proprietary Blend (Herb/Botanical)
((750 mg. per tablet) of:)
(Proprietary Blend (Herb/Botanical) Note: (750 mg. per tablet) of: )
|
2250 mg |
(Sanguisorba )
(root)
|
0 Not Present |
(Pulsatilla )
(root)
|
0 Not Present |
Sophora
(Sophora )
(flower)
|
0 Not Present |
(root)
|
0 Not Present |
(root)
|
0 Not Present |
(Rehmannia )
(root)
(raw)
(Rehmannia PlantPart: root Genus: Rehmannia Note: raw )
|
0 Not Present |
(Fraxinus )
(cortex)
|
0 Not Present |
(Phellodendron )
(cortex)
|
0 Not Present |
(Lonicera )
(flower)
|
0 Not Present |
Vegetable Gum, Silicon Dioxide (Alt. Name: SiO2), Stearic Acid (Alt. Name: C18:0), Cellulose
Below is general information about the effectiveness of the known ingredients contained in the product Formula H. 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
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
There is insufficient reliable information available about the effectiveness of pulsatilla.
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product Formula H. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
POSSIBLY SAFE ...when used orally and appropriately. Ash seed/fruit extract (FraxiPure, Naturex; now marketed as Glucevia) has been used safely in doses of up to 1 gram daily for 3 weeks to 3 months (100051,100053).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
POSSIBLY SAFE ...when used orally and appropriately. Dong quai has been used with apparent safety in a dose of 4.5 grams daily for 24 weeks, or in combination with other ingredients in doses of up to 150 mg daily for up to 6 months (19552,35797). ...when used intravenously as a 25% solution, in a dose of 200-250 mL daily for up to 20 days (48438,48442,48443,48483).
POSSIBLY UNSAFE ...when used orally in large amounts, long-term. Theoretically, long-term use of large amounts of dong quai could be harmful. Dong quai contains several constituents such as bergapten, safrole, and isosafrole that are considered carcinogenic (7162). There is insufficient reliable information available about the safety of dong quai when used topically.
PREGNANCY: POSSIBLY UNSAFE
when used orally.
Dong quai has uterine stimulant and relaxant effects (8142); theoretically, it could adversely affect pregnancy. Observational research has found that intake of An-Tai-Yin, an herbal combination product containing dong quai and parsley, during the first trimester is associated with an increased risk of congenital malformations of the musculoskeletal system, connective tissue, and eyes (15129).
LACTATION:
Insufficient reliable information available; avoid use.
POSSIBLY SAFE ...when used topically, short-term. A lotion containing greater burnet dried root extract in a concentration of 800 parts per million has been used with apparent safety twice daily for 8 weeks (103055). There is insufficient reliable information available about the safety of greater burnet when used orally.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
POSSIBLY SAFE ...when used orally and appropriately, short term. Total glucosides of peony has been used with apparent safety in doses of up to 1800 mg daily for up to 12 months (92786,97949,97950,98466,100992,110432,112861,112862). Peony root extract has been used with apparent safety at a dose of 2250 mg daily for up to 3 months (97216). There is insufficient reliable information available about the safety of peony when used orally, topically, or rectally, long-term.
CHILDREN: POSSIBLY SAFE
when used orally and appropriately, short-term.
Total glucosides of peony has been used with apparent safety in children 1.5-4 years of age at doses up to 180 mg/kg daily or 1.2 grams daily for up to 12 months (92785). Peony root extract 40 mg/kg daily has also been used with apparent safety in children 1-14 years of age for 4 weeks (106851).
PREGNANCY: POSSIBLY UNSAFE
when used orally.
Preliminary research suggests that peony can cause uterine contractions (13400). However, other preliminary research suggests a combination of peony and angelica with or without motherwort, banksias rose, and ligustica, might be safe (11015,48433). Until more is known, avoid use.
LACTATION:
Insufficient reliable information available; avoid using.
POSSIBLY SAFE ...when used orally and appropriately in combination with other ingredients, short-term. A specific product containing a combination of extracts of phellodendron plus magnolia (Relora, Next Pharmaceuticals) 250 mg 2-3 times daily has been used with apparent safety in clinical trials lasting up to 6 weeks (14349,94901,94904). Also, a specific product containing a combination of extracts of phellodendron plus sweet orange (Citrofen, Next Pharmaceuticals) 740 mg twice daily has been used with apparent safety for up to 8 weeks (94903). ...when used topically (97317). There is insufficient reliable information available about the safety of phellodendron when used orally as a single ingredient.
CHILDREN: LIKELY UNSAFE
when used orally in newborns.
The berberine constituent of phellodendron can cause kernicterus in newborns, particularly preterm neonates with hyperbilirubinemia (2589).
PREGNANCY: LIKELY UNSAFE
when used orally.
The berberine constituent of phellodendron is thought to cross the placenta and may cause harm to the fetus. Kernicterus has developed in newborn infants exposed to berberine (2589).
LACTATION: LIKELY UNSAFE
when used orally.
The berberine constituent of phellodendron and other harmful constituents can be transferred to the infant through breast milk (2589).
LIKELY UNSAFE ...when fresh above ground parts are used orally or topically; pulsatilla is a severe local irritant (4). There is insufficient reliable information available about the safety of the use of dried pulsatilla.
PREGNANCY: LIKELY UNSAFE
when used orally.
The fresh or dried above ground parts are contraindicated due to abortifacient and teratogenic effects (2,4). ...when the fresh above ground parts are used topically. There is insufficient reliable information available about the safety of topical dried pulsatilla during pregnancy.
LACTATION: LIKELY UNSAFE
when the fresh above ground parts are used for oral or topical use (19).
There is insufficient reliable information available about the safety of dried pulsatilla during breast-feeding.
POSSIBLY SAFE ...when used orally and appropriately, short term. Rehmannia root extract 4 grams daily or rehmannia leaf extract 800 mg daily has been used with apparent safety for 8 weeks in clinical studies (93660,93662).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
Below is general information about the interactions of the known ingredients contained in the product Formula H. 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, concomitant use with antidiabetes drugs might affect glucose control and increase the risk of hypoglycemia. Dose adjustments to diabetes medications might be necessary. Animal research shows that ash seed/fruit extract reduces fasting levels of glucose (100052). Although clinical research in patients without diabetes shows that ash seed/fruit extract does not significantly affect blood glucose levels, insulin levels, or homeostatic model of insulin resistance (HOMA-IR), it may lower the incremental glucose area under the curve and decrease 2-hour blood glucose following an oral glucose tolerance test (100051,100054). Ash seed/fruit extract has not been evaluated in patients with diabetes. Until more is known, use cautiously in patients taking antidiabetes drugs.
Details
Some antidiabetes drugs include glimepiride (Amaryl), glyburide (DiaBeta, Glynase PresTab, Micronase), insulin, metformin (Glucophage), pioglitazone (Actos), rosiglitazone (Avandia), and others.
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Theoretically, concomitant use of ash seed with antihypertensive drugs might have additive blood pressure lowering effects. Animal research shows that ash seed extract can decrease blood pressure (100052). This effect has not been evaluated in humans. Until more is known, use cautiously in patients taking antihypertensive drugs.
Details
Some antihypertensive drugs include nifedipine (Adalat, Procardia), verapamil (Calan, Isoptin, Verelan), diltiazem (Cardizem), isradipine (DynaCirc), felodipine (Plendil), amlodipine (Norvasc), and others.
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Theoretically, dong quai may increase the risk of bleeding when used with anticoagulant or antiplatelet drugs; however, research is conflicting.
Details
Animal studies suggest that dong quai has antithrombin activity and inhibits platelet aggregation due to its coumarin components (6048,10057,96137). Additionally, some case reports in humans suggest that dong quai can increase the anticoagulant effects of warfarin (3526,6048,23310,48439). However, clinical research in healthy adults shows that taking 1 gram of dong quai root daily for 3 weeks does not significantly inhibit platelet aggregation or cause bleeding (96137). Until more is known, use dong quai with caution in patients taking antiplatelet/anticoagulant drugs.
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Theoretically, dong quai may reduce the effects of estrogens.
Details
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Dong quai may increase the risk of bleeding when used with warfarin.
Details
Case reports suggest that concomitant use of dong quai with warfarin can increase the anticoagulant effects of warfarin and increase the risk of bleeding (3526,6048,23310,48439). In one case, after 4 weeks of taking dong quai 565 mg once or twice daily, the international normalized ratio (INR) increased to 4.9. The INR normalized 4 weeks after discontinuation of dong quai (3526).
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Theoretically, honeysuckle might increase the risk of bleeding when taken with anticoagulant or antiplatelet drugs.
Details
In vitro research shows that polyphenols extracted from honeysuckle can inhibit platelet aggregation (12610).
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Theoretically, combining peony with anticoagulant or antiplatelet drugs might increase the risk of bleeding.
Details
In vitro research suggests that peony might have antiplatelet, anticoagulant, and antithrombotic effects (92787).
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Theoretically, peony might increase the levels and clinical effects of clozapine.
Details
In vitro research shows that peony suppresses the metabolism of clozapine via weak-to-moderate inhibitory effects on cytochromes P450 (CYP) 1A2 and CYP3A4 (92790). This effect has not been reported in humans.
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Theoretically, peony might interfere with contraceptive drugs due to competition for estrogen receptors.
Details
In vitro and animal research shows that peony extract has estrogenic activity (100990). Concomitant use might also increase the risk for estrogen-related adverse effects.
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Theoretically, use of peony may increase the levels and clinical effects of drugs metabolized by CYP1A2.
Details
In vitro research shows that peony suppresses the metabolism of clozapine via weak-to-moderate inhibitory effects on CYP1A2 and CYP3A4 (92790). This effect has not been reported in humans.
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Theoretically, use of peony may increase the levels and clinical effects of drugs metabolized by CYP3A4.
Details
In vitro research shows that peony suppresses the metabolism of clozapine via weak-to-moderate inhibitory effects on CYP1A2 and CYP3A4 (92790). This effect has not been reported in humans.
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Theoretically, concomitant use of large amounts of peony might interfere with hormone replacement therapy and/or increase the risk for estrogen-related adverse effects.
Details
In vitro and animal research shows that peony extract has estrogenic activity (100990). Theoretically, peony might compete for estrogen receptors and/or cause additive estrogenic effects.
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Theoretically, peony might reduce the levels and clinical effects of phenytoin.
Details
Animal research shows that taking peony root reduces levels of phenytoin (8657). Some researchers suggest that peony root might affect cytochrome P450 (CYP) 2C9, which metabolizes phenytoin. However, preliminary research in humans shows that peony root does not alter levels of losartan (Cozaar), which is also metabolized by CYP2C9 (11480).
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Theoretically, phellodendron might increase the risk of bleeding when used with anticoagulant or antiplatelet drugs.
Details
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Theoretically, phellodendron may increase the risk of hypoglycemia when taken with antidiabetes drugs.
Details
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Theoretically, phellodendron might have additive effects with antihypertensive drugs.
Details
Phellodendron contains berberine. Animal research suggests that berberine can have hypotensive effects (33692,34308). Also, a clinical study suggests that taking berberine in combination with amlodipine can lower systolic and diastolic blood pressure when compared with amlodipine alone (91956). Theoretically, phellodendron might also reduce blood pressure.
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Theoretically, phellodendron might increase the sedative effects of CNS depressants.
Details
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Theoretically, phellodendron might increase blood levels of cyclosporine.
Details
Phellodendron contains berberine. Preliminary clinical research shows that berberine can reduce metabolism of cyclosporine and increase serum levels, likely through inhibition of cytochrome P450 3A4 (CYP3A4), which metabolizes cyclosporine (13524). Theoretically, phellodendron might also reduce the metabolism of cyclosporine.
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Theoretically, phellodendron might increase serum levels of drugs metabolized by CYP2C9.
Details
Phellodendron contains berberine. Preliminary clinical research shows that berberine can inhibit CYP2C9 (34279). Theoretically, phellodendron might also inhibit CYP2C9.
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Theoretically, phellodendron might increase serum levels of drugs metabolized by CYP2D6.
Details
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Theoretically, phellodendron might increase serum levels of drugs metabolized by CYP3A4.
Details
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Theoretically, phellodendron may increase serum levels of dextromethorphan.
Details
Phellodendron contains berberine. Preliminary clinical research shows that berberine can inhibit cytochrome P450 2D6 (CYP2D6) activity and reduce the metabolism of dextromethorphan (34279). Theoretically, phellodendron may also inhibit the metabolism of dextromethorphan.
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Theoretically, phellodendron might reduce the therapeutic effects of losartan by decreasing its conversion to its active form.
Details
Phellodendron contains berberine. Preliminary clinical research suggests that berberine can inhibit cytochrome P450 2C9 (CYP2C9) activity and reduce metabolism of losartan (34279). Theoretically, phellodendron might also inhibit the metabolism of losartan.
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Theoretically, phellodendron might increase the therapeutic and adverse effects of metformin.
Details
Phellodendron contains berberine. In vitro and animal studies show that berberine can increase the systemic exposure and half-life of metformin, potentially increasing metformin's effects and side effects. This interaction seems to be most apparent when berberine is administered 2 hours prior to metformin. Taking berberine and metformin at the same time does not appear to increase systemic exposure to metformin (103195). It is unclear if phellodendron might have this same effect.
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Theoretically, phellodendron might reduce metabolism of midazolam, which might increase the risk of severe adverse effects.
Details
Phellodendron contains berberine. Preliminary clinical research shows that berberine can inhibit cytochrome P450 3A4 (CYP3A4) activity and reduce metabolism of midazolam (34279). Theoretically, phellodendron might also inhibit the metabolism of midazolam.
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Theoretically, phellodendron might increase the sedative effect of pentobarbital.
Details
Phellodendron contains berberine. Animal research shows that berberine can prolong pentobarbital-induced sleeping time (13519). Theoretically, phellodendron might increase the sedative effects of pentobarbital.
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Theoretically, phellodendron might increase blood levels of tacrolimus.
Details
Phellodendron contains berberine. In a 16-year-old patient with idiopathic nephrotic syndrome who was being treated with tacrolimus 6.5 mg twice daily, intake of berberine 200 mg three times daily increased the blood concentration of tacrolimus from 8 to 22 ng/mL. Following a reduction of the tacrolimus dose to 3 mg daily, blood levels of tacrolimus decreased to 12 ng/mL (91954). It is unclear if phellodendron might have this same effect.
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Theoretically, rehmannia might increase the risk of hypoglycemia when taken with antidiabetes drugs.
Details
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Theoretically, rehmannia might increase the risk of hypotension when taken with antihypertensive drugs.
Details
Animal research shows that rehmannia may have hypotensive effects. Laboratory research shows that formulations of dried and processed rehmannia root inhibit angiotensin-converting enzyme (ACE) (104272).
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Below is general information about the adverse effects of the known ingredients contained in the product Formula H. 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, dong quai is generally well-tolerated.
Most Common Adverse Effects:
Orally: Burping and flatulence.
Intravenously: Headache.
Cardiovascular ...Orally, dong quai might cause hypertension; according to one case report, a parent and breastfed infant experienced hypertension (195/85 mmHg and 115/69 mmHg, respectively) after the parent consumed a soup containing dong quai root (48428).
Dermatologic ...Dong quai contains psoralens that may cause photosensitivity and photodermatitis (10054,10057,48461).
Endocrine ...In a case report, a male developed gynecomastia after ingesting dong quai tablets (48504).
Gastrointestinal ...Orally, burping and gas may occur with dong quai (738).
Hematologic ...In one case report, a 55-year-old female with protein S deficiency and systemic lupus erythematosus (SLE) had temporary vision loss in the left eye from hemiretinal vein thrombosis three days after taking a phytoestrogen preparation containing dong quai 100 mg, black cohosh 250 mg, wild Mexican yam 276 mg, and red clover 250 mg (13155). It is unclear if dong quai contributed to this event.
Neurologic/CNS ...Dong quai given orally or by injection may be associated with headache (738,48438).
Oncologic ...Dong quai contains constituents that are carcinogenic; however, whether these constituents are present in concentrations large enough to cause cancer with long-term or high-dose use is unknown (7162).
Pulmonary/Respiratory ...A pharmacist experienced allergic asthma and rhinitis after occupational exposure to dong quai and other herbs (48435).
General ...No adverse effects have been reported. However, a thorough evaluation of safety outcomes has not been conducted.
General ...Orally, honeysuckle seems to be well tolerated. No adverse effects have been reported. There is insufficient reliable information available about the safety of honeysuckle when used topically. However, a thorough evaluation of safety outcomes has not been conducted.
Immunologic ...Topically, applying honeysuckle to the skin has been associated with contact dermatitis in a case report (12611). Orally, a case of biopsy-confirmed allergic drug eruption is reported in a young adult male after taking honeysuckle granules 30 grams over a 24-hour period. Symptoms resolved with discontinuation of honeysuckle and 2-weeks of antihistamine and glucocorticoid therapy (112866).
General
...Orally, peony seems to be well tolerated when used alone and as part of Chinese herbal formulas.
Most Common Adverse Effects:
Orally: Abdominal distension, anorexia, diarrhea, gastrointestinal discomfort, nausea.
Topically: Dermatitis.
Dermatologic ...Topically, peony has been reported to cause contact dermatitis (13555).
Endocrine ...Orally, a specific traditional Chinese medicine preparation called DDT has been reported to lower follicle-stimulating hormone (FSH) levels and increase estradiol levels. It is not known if this effect is due to peony or the other ingredients (48404). Another specific traditional Chinese medicine preparation, Toki-shakuyaku-san, has been reported to increase plasma progesterone levels in some patients. It is not known if this effect is due to peony or the other ingredients (15294).
Gastrointestinal ...Orally, peony and total glucosides of peony (TGP) have been reported to cause gastrointestinal discomfort, including abdominal distension, anorexia, diarrhea, and nausea, in some patients (13538,92785,97949,98466,100992). In one clinical study, diarrhea was reported in 5% of patients taking TGP 600 mg three times daily for 24 weeks versus 1% of patients taking placebo (100992).
Hematologic ...Orally, there is one case report of easy gum bleeding, epistaxis, and skin bruising with an international normalized ratio (INR) above 6 in a 61-year-old male who was previously stable on warfarin therapy. This patient had switched from one brand of quilinggao, a popular Chinese herbal product, to another brand 5 days prior. This product contained Fritillaria spp. (beimu), Paeonia rubra, Chinese peony (chishao), Lonicera japonica (jinyinhua), and Poncirus trifoliata (jishi). The patient's INR decreased to 1.9 after temporary withdrawal of warfarin therapy. Upon re-initiation of quilinggao, his INR increased to 5.2. It is not known if the increased INR is due to peony or the other ingredients (68343).
General ...Orally, phellodendron seems to be well tolerated.
Endocrine ...Orally, a combination product containing extracts of phellodendron plus magnolia has been associated with one report of thyroid dysfunction in one clinical trial (14349,94901). However, it is unknown if this is related to phellodendron or some other factor.
Gastrointestinal ...Orally, a combination product containing extracts of phellodendron plus magnolia has been associated with one report of heartburn in one clinical trial (14349,94901). However, it is unknown if this is related to phellodendron or some other factor.
Genitourinary ...Orally, a combination product containing extracts of phellodendron plus magnolia has been associated with one report of sexual dysfunction in one clinical trial (14349,94901). However, it is unknown if this is related to phellodendron or some other factor.
Neurologic/CNS ...Orally, a combination product containing extracts of phellodendron plus magnolia has been associated with single reports of shaking hands, perilabial numbness, fatigue, and headache in clinical research (14349,94901). However, it is unknown if this is related to phellodendron or some other factor.
General
...Orally, fresh pulsatilla is a toxic gastrointestinal irritant (4,19).
It can also cause kidney and urinary tract irritation (2).
Topically, contact with the fresh plant can cause skin irritation, mucous membrane irritation, itching, and pustule formation known as ranunculus dermatitis (2). Allergic reactions to pulsatilla volatile oil have been documented with patch tests (4).
Inhalation of pulsatilla volatile oil may cause nasal mucosal and conjunctival irritation (4).
Dermatologic ...Topically, contact with the fresh plant can cause skin irritation, mucous membrane irritation, itching, and pustule formation known as ranunculus dermatitis (2).
Gastrointestinal ...Orally, fresh pulsatilla is a toxic gastrointestinal irritant (4,19).
Genitourinary ...Orally, fresh pulsatilla can cause urinary tract irritation (2).
Immunologic ...Topically, allergic reactions to the protoanemonin-containing volatile oil of pulsatilla have been documented with patch tests (4).
Ocular/Otic ...Inhalation of the protoanemonin-containing volatile oil of pulsatilla may cause conjunctival irritation (4).
Pulmonary/Respiratory ...Inhalation of the protoanemonin-containing volatile oil of pulsatilla may cause nasal mucosal irritation (4).
Renal ...Orally, fresh pulsatilla can cause kidney irritation (2).
General ...Orally, rehmannia seems to be well tolerated.