Ingredients | Amount Per Serving |
---|---|
Fast-Acting Comfort Blend
|
250 mg |
(Acacia catechu )
(wood & bark)
|
|
Chinese Skullcap Root Extract
(Root)
|
|
UC-II(R) natural Collagen concentrate
|
40 mg |
10 mg | |
(Sodium Hyaluronate)
(Hyaluronic Acid (Form: as Sodium Hyaluronate) )
|
5 mg |
Dicalcium Phosphate, Titanium Dioxide, Vegetable Acetoglycerides, Riboflavin
Below is general information about the effectiveness of the known ingredients contained in the product Comfort. 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 Comfort. 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 orally in amounts commonly found in foods. Catechu has Generally Recognized As Safe (GRAS) status for use in foods in the US (4912). There is insufficient reliable information available about the safety of catechu when used orally in medicinal amounts. A specific product (Limbrel, Primus Pharmaceuticals) containing flavocoxid, a mixture of flavonoid extracts from catechu and Baikal skullcap, has been associated with an increased risk for liver and lung injury. In 2017, the US Food and Drug Administration (FDA) formally requested the recall of all non-expired lots of this product (106042). It is unclear if these effects were due to catechu, Baikal skullcap, or the combination. There is insufficient reliable information available about the safety of catechu when used topically.
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in amounts commonly found in foods.
Catechu has Generally Recognized As Safe (GRAS) status for use in foods in the US (4912). There is insufficient reliable information available about the safety of catechu when used orally in medicinal amounts or when used topically during pregnancy and lactation.
LIKELY SAFE ...when used orally and appropriately. Supplements standardized to contain hyaluronic acid 70%, in an 80 mg daily dose, have been used daily for up to 3 months with no reports of adverse effects (55742,91779). ...when used topically and appropriately. Hyaluronic acid, in a gel or impregnated gauze, has been safely applied to the skin in clinical trials (7889,7892,104389,108627,108640). ...when eye drop preparations containing up to 0.3% hyaluronic acid are used multiple times per day for up to 3 months (97885,97894,97895,110555).
PREGNANCY:
There is insufficient reliable information available about the safety of hyaluronic acid; avoid using.
LACTATION:
There is insufficient reliable information available about the safety of hyaluronic acid.
It is not known if hyaluronic acid is excreted in breast milk (7890); avoid using.
Below is general information about the interactions of the known ingredients contained in the product Comfort. 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 antihypertensive drugs might increase the risk of hypotension.
Details
Catechu might lower blood pressure (14144).
|
Theoretically, black catechu may increase the levels and clinical effects of CYP1A2 substrates.
Details
Animal research shows that black catechu can increase theophylline concentrations in the blood, possibly by inhibiting CYP1A2 (94560). Theophylline is a CYP1A2 substrate.
|
Theoretically, catechu might interfere with immunosuppressant therapy.
Details
Animal and in vitro studies suggest that catechu has immunomodulating effects (103271).
|
Theoretically, black catechu may increase the levels and clinical effects of theophylline.
Details
Animal research shows that black catechu can increase theophylline concentrations in the blood, possibly by inhibiting cytochrome P450 1A2 (94560).
|
Below is general information about the adverse effects of the known ingredients contained in the product Comfort. 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 ...There is limited reliable information available about the adverse effects of catechu when used orally or topically as a single ingredient. A specific combination product (Limbrel, Primus Pharmaceuticals) containing flavonoid extracts of catechu and Baikal skullcap has been associated with serious adverse effects, including liver and lung injury.
Hepatic
...A specific combination product (Limbrel, Primus Pharmaceuticals) containing flavocoxid, a mixture of flavonoid extracts from catechu and Baikal skullcap, has been linked to several reports of acute liver damage.
In a case series, four reports of liver damage were described in patients taking this product. The patients involved were females aged 54-68 years taking doses of 250-500 mg twice daily for 1-3 months. Signs and symptoms included jaundice, pruritus, abdominal pain, fever, rash, and elevated serum and liver transaminase levels. All patients fully recovered and levels normalized within 3 months after discontinuation (18009,18011). In addition to these published case reports, approximately 30 liver-related adverse events have been reported to the manufacturer of this product (18009). The mechanism of hepatotoxicity is unclear (18009,18010); it is estimated that the incidence of hepatotoxicity with this product is around 1 in 10,000, although the actual incidence is unknown (18010). In 2017, the US Food and Drug Administration (FDA) formally requested the recall of all non-expired lots of this product due to the risk for liver and lung injury (106042). It is unclear if these effects were due to catechu, Baikal skullcap, or the combination.
More recently, in another case report, a 54-year-old female reported to the emergency room with acute hepatitis possibly due to taking a preparation of catechu and Baikal skullcap for 2-4 weeks. Causation was unable to be established. After discontinuing the supplements and supportive treatment, liver function returned to normal (94563). It was unclear if the catechu product was the same specific combination product (Limbrel, Primus Pharmaceuticals) associated with previous reports of liver damage.
Pulmonary/Respiratory ...A specific combination product (Limbrel, Primus Pharmaceuticals) containing flavocoxid, a mixture of flavonoid extracts from catechu and Baikal skullcap, has been linked to several reports of hypersensitivity pneumonitis. Symptoms include fever, chills, headache, cough, chronic bronchitis, shortness of breath, weight loss, and fatigue. In 2017, the US Food and Drug Administration (FDA) formally requested the recall of all non-expired lots of this product due to the risk for liver and lung injury (106042). It is unclear if these effects were due to catechu, Baikal skullcap, or the combination.
General
...Orally, collagen type II seems to be well tolerated.
Most Common Adverse Effects:
Orally: Abdominal pain, constipation, nausea, and vomiting.
Cardiovascular ...Orally, one incident of mild hypertension was reported as being possibly related to collagen type II in a clinical trial of children (101719).
Dermatologic ...Orally, collagen type II might cause itching. In two cases, the itching was associated with skin eruption (44451,101717,101719).
Gastrointestinal ...Orally, the most common adverse effects of collagen type II reported in clinical studies are gastrointestinal and include constipation, nausea, vomiting, and abdominal pain. These occurred in up to 7% of patients taking collagen type II (44451,97238,97239,101717,101719). Anorexia was also reported, but this was much less common (44451).
Hematologic ...Orally, one incident each of blood in urine and a decrease in white blood cell count were reported for patients taking collagen type II in clinical research (101717).
Hepatic ...Orally, liver function abnormalities, including elevated transaminase levels, have been reported in some clinical research, but this is uncommon (3111,44451,101717).
Neurologic/CNS ...Orally, headache, dizziness, and insomnia have been reported for patients taking collagen type II in clinical studies, but these events are uncommon (44451,97238,97239,101717).
Renal ...Orally, one case of mild proteinuria was reported as being possibly related to use of collagen type II in a clinical trial of children (101719).
Other ...Orally, edema occurred in two patients taking collagen type II in clinical research (101717).
General
...Orally and topically, hyaluronic acid appears to be well tolerated.
Most Common Adverse Effects:
Topically: Eczema, erythema, itching, wound hemorrhage, wound infection (e.g., erysipelas).
Dermatologic
...The use of needle-free devices to inject hyaluronic acid for cosmetic purposes has been reported to cause serious injury, and in some cases permanent harm, to the skin, lips, and eyes (108613).
Topically, hyaluronic acid application has been reported to cause eczema, erythema, itching, wound hemorrhage, and wound infection (e.g., erysipelas) (108628,108640).
Ocular/Otic ...Ocular pain has been reported rarely in patients using eye drops containing up to 0. 3% hyaluronic acid (97885).