Ingredients | Amount Per Serving |
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1000 mcg | |
(roots)
(standardized for 1.5% Total Withanolides)
(Ashwagandha extract (Form: standardized for 1.5% Total Withanolides Note: 3.75 mg) PlantPart: roots )
|
250 mg |
(root)
|
500 mg |
500 mg |
Gelatin, Rice Flour, Magnesium Stearate
Below is general information about the effectiveness of the known ingredients contained in the product GrayStop Plus. 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
Below is general information about the safety of the known ingredients contained in the product GrayStop Plus. 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, short-term. Ashwagandha has been used with apparent safety in doses of up to 1250 mg daily for up to 6 months (3710,11301,19271,90649,90652,90653,97292,101816,102682,102683) (102684,102685,102687,103476,105824,109586,109588,109589,109590). ...when used topically. Ashwagandha lotion has been used with apparent safety in concentrations up to 8% for up to 2 months (111538).
PREGNANCY: LIKELY UNSAFE
when used orally.
Ashwagandha has abortifacient effects (12).
LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when used orally and appropriately. Biotin has been safely used in doses up to 300 mg daily for up to 6 months. A tolerable upper intake level (UL) has not been established (1900,6243,95662,102965). ...when applied topically as cosmetic products at concentrations of 0.0001% to 0.6% biotin (19344).
POSSIBLY SAFE ...when used intramuscularly and appropriately (8468,111366).
CHILDREN: LIKELY SAFE
when used orally and appropriately.
Biotin has been safely used at adequate intake doses of 5-25 mcg daily for up to 6 months (173,6243,19347,19348,111365). A tolerable upper intake level (UL) has not been established.
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally and appropriately.
Biotin has been safely used at the adequate intake (AI) dose of 30 mcg daily during pregnancy and 35 mcg daily during lactation. It has also been used in supplemental doses of up to 300 mcg daily (6243,7878). A tolerable upper intake level (UL) has not been established.
POSSIBLY UNSAFE ...when used orally. Fo-ti has been linked to several cases of liver damage (7626,7627,14327,14347,14482,16459,17192,50711,50727,50729) (92892,92895,112231).
CHILDREN: POSSIBLY UNSAFE
when used orally.
Fo-ti has been linked to several cases of liver damage in adults and at least one case in a 5-year-old child (14339,92895).
PREGNANCY: POSSIBLY UNSAFE
when used orally.
Fo-ti contains anthraquinone constituents, which can exert a stimulant laxative effect. Bulk-forming or emollient laxatives are preferred in pregnancy (272). Fo-ti has also been linked to several cases of liver damage (7626,7627,14327). There is insufficient reliable information available about the safety of fo-ti when used topically during pregnancy.
LACTATION: POSSIBLY UNSAFE
when used orally.
Anthraquinone constituents can cross into breast milk and might cause loose stools in some breast-fed infants (272). Fo-ti has also been linked to several cases of liver damage (7626,7627,14327). There is insufficient reliable information available about the safety of fo-ti when used topically during lactation.
POSSIBLY SAFE ...when used orally and appropriately, short-term. Inositol has been used with apparent safety in doses up to 18 grams daily for up to 6 weeks or 6 grams daily for 10 weeks (2184,2185,2187,95089). Myo-inositol 4 grams daily has also been used with apparent safety for 6 months (95085). There is insufficient reliable information available about the safety of inositol when used topically.
CHILDREN: POSSIBLY SAFE
when used orally and appropriately.
Inositol 80 mg/kg (maximum 2 grams) has been taken daily for up to 12 weeks in children aged 5-12 years (95092). ...when used enterally or intravenously and appropriately in premature infants for treating acute respiratory distress syndrome for up to 10 days (2191,2192,91546,91551).
CHILDREN: POSSIBLY UNSAFE
when used enterally or intravenously for extended durations in premature infants.
A large clinical study in infants born at less than 28 weeks' gestation found that myo-inositol 40 mg/kg, given intravenously and then enterally every 12 hours for up to 10 weeks, was associated with a small increased risk of death (98946). Long-term follow-up until 24 months corrected age confirms that the initial increase in mortality rate in the myo-inositol group remained stable; however, there was no difference in a composite outcome of death or survival with moderate or severe neurodevelopmental impairment, as well as no difference in the risk of retinopathy of prematurity, between those who received myo-inositol or control (108819).
PREGNANCY: POSSIBLY SAFE
when used orally and appropriately, short-term.
Myo-inositol has been used with apparent safety in amounts up to 4000 mg daily during pregnancy (91548,95082,104688).
LACTATION:
Insufficient reliable information available; avoid using.
Breast milk is rich in endogenous inositol (2138); however, the effects of exogenously administered inositol are not known.
Below is general information about the interactions of the known ingredients contained in the product GrayStop Plus. 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 ashwagandha with antidiabetes drugs might increase the risk of hypoglycemia.
Details
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Theoretically, taking ashwagandha with antihypertensive drugs might increase the risk of hypotension.
Details
Animal research suggests that ashwagandha might lower systolic and diastolic blood pressure (19279). Theoretically, ashwagandha might have additive effects when used with antihypertensive drugs and increase the risk of hypotension.
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Theoretically, taking ashwagandha might increase the sedative effects of benzodiazepines.
Details
There is preliminary evidence that ashwagandha might have an additive effect with diazepam (Valium) and clonazepam (Klonopin) (3710). This may also occur with other benzodiazepines.
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Theoretically, taking ashwagandha might increase the sedative effects of CNS depressants.
Details
Ashwagandha seems to have sedative effects. Theoretically, this may potentiate the effects of barbiturates, other sedatives, and anxiolytics (3710).
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Theoretically, taking ashwagandha might decrease the effects of immunosuppressants.
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Ashwagandha might increase the effects and adverse effects of thyroid hormone.
Details
Concomitant use of ashwagandha with thyroid hormones may cause additive therapeutic and adverse effects. Preliminary clinical research and animal studies suggest that ashwagandha boosts thyroid hormone synthesis and secretion (19281,19282,97292). In one clinical study, ashwagandha increased triiodothyronine (T3) and thyroxine (T4) levels by 41.5% and 19.6%, respectively, and reduced serum TSH levels by 17.4% from baseline in adults with subclinical hypothyroidism (97292).
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Theoretically, fo-ti might increase the risk of hypoglycemia when taken with antidiabetes drugs.
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Theoretically, taking large amounts of fo-ti might interfere with contraceptive drugs due to competition for estrogen receptors.
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Theoretically, fo-ti might increase or decrease the levels and clinical effects of drugs metabolized by CYP1A2.
Details
In vitro research suggests that fo-ti might inhibit CYP1A2 (12479,112351). Additionally, in vitro research suggests that the degree of CYP1A2 inhibition depends on the type of fo-ti extract (i.e., the raw plant leads to greater inhibition than extensively processed extracts) (112351). However, in an animal study, an aqueous extract of fo-ti inhibited CYP1A2 while an alcoholic extract of fo-ti induced CYP1A2 (92898). Induction or inhibition of CYP1A2 by fo-ti has not been reported in humans.
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Theoretically, fo-ti might increase the levels and clinical effects of drugs metabolized by CYP2B6.
Details
Animal research suggests that fo-ti might inhibit CYP2B6 (92898). One in vitro study suggests that the degree of CYP2B6 inhibition may depend on the type of fo-ti extract (i.e., the raw plant leads to greater inhibition than extensively processed extracts) (112351). However, this interaction has not been reported in humans.
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Theoretically, fo-ti may increase the levels and clinical effects of drugs metabolized by CYP2C19.
Details
Animal and in vitro research suggests that fo-ti may inhibit CYP2C19 (12479,92898,112351). An in vitro study suggests that the degree of CYP2C19 inhibition may depend on the type of fo-ti extract (i.e., the raw plant leads to greater inhibition than extensively processed extracts) (112351). However, this interaction has not been reported in humans.
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Theoretically, fo-ti might increase the levels and clinical effects of drugs metabolized by CYP2C8.
Details
In vitro research suggests that fo-ti might inhibit CYP2C8 (112351). However, this interaction has not been reported in humans.
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Theoretically, fo-ti may increase the levels and clinical effects of drugs metabolized by CYP2C9.
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Theoretically, fo-ti may increase the levels and clinical effects of drugs metabolized by CYP2D6.
Details
Animal research suggests that fo-ti might inhibit CYP2D6 (92898). Additionally, an in vitro study suggests that the degree of CYP2D6 inhibition may depend on the type of fo-ti extract (i.e., the raw plant leads to greater inhibition than extensively processed extracts) (112351). However, this interaction has not been reported in humans.
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Theoretically, fo-ti might increase the levels and clinical effects of drugs metabolized by CYP3A4.
Details
In vitro research suggests that fo-ti might inhibit CYP3A4 (12479,112351). One in vitro study suggests that the degree of CYP3A4 inhibition may depend on the type of fo-ti extract (i.e., the raw plant leads to greater inhibition than extensively processed extracts) (112351). However, this evidence conflicts with animal research suggesting that fo-ti does not inhibit CYP3A4 (92898). This interaction has not been reported in humans.
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Theoretically, fo-ti, particularly raw fo-ti root, might increase the risk of hypokalemia and cardiotoxicity when taken with digoxin.
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Theoretically, fo-ti, particularly raw fo-ti root, might increase the risk of hypokalemia when taken with diuretic drugs.
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Theoretically, taking large amounts of fo-ti might interfere with hormone replacement therapy through competition for estrogen receptors.
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Theoretically, fo-ti might increase the risk of liver damage when taken with hepatotoxic drugs.
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Theoretically, fo-ti, particularly raw fo-ti root, might increase the risk of fluid and electrolyte depletion when taken with stimulant laxatives.
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Theoretically, fo-ti might increase or decrease the levels and clinical effects of sulindac.
Details
Animal research suggests that the type of fo-ti extract might affect the levels of sulindac differently; the raw plant may increase levels, but processed parts may decrease levels (112351). Induction or inhibition of CYP1A2 by fo-ti has not been reported in humans.
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Theoretically, fo-ti might increase the effects and adverse effects of warfarin.
Details
Fo-ti may have stimulant laxative effects and cause diarrhea, especially when the raw or unprocessed fo-ti root is used (5,12,16459,50733,99855). Diarrhea can increase the effects of warfarin, increase international normalized ratio (INR), and increase the risk of bleeding. Also, fo-ti has been linked to cases of acute liver failure which can decrease clotting factor production and increase the effects of warfarin. In one case, a patient who had been stable on warfarin presented with acute hepatitis and an INR elevated to 14.98. The patient had been taking fo-ti for 90 days prior to admission. Discontinuation of warfarin and fo-ti lead to a decrease in the INR and full recovery (17192).
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Theoretically, taking inositol with antidiabetes drugs might increase the risk of hypoglycemia.
Details
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Below is general information about the adverse effects of the known ingredients contained in the product GrayStop Plus. 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, ashwagandha seems to be well-tolerated.
Topically, no adverse effects have been reported. However, a thorough evaluation of safety outcomes has not been conducted.
Most Common Adverse Effects:
Orally: Diarrhea, gastrointestinal upset, nausea, and vomiting. However, these adverse effects do not commonly occur with typical doses.
Serious Adverse Effects (Rare):
Orally: Some case reports raise concerns about acute liver failure, hepatic encephalopathy, and the need for liver transplantation with ashwagandha treatment.
Dermatologic ...Orally, dermatitis has been reported in three of 42 patients in a clinical trial (19276).
Endocrine ...A case report describes a 73-year-old female who had taken an ashwagandha root extract (unspecified dose) for 2 years to treat hypothyroidism which had been previously managed with levothyroxine. The patient was diagnosed with hyperthyroidism after presenting with supraventricular tachycardia, chest pain, tremor, dizziness, fatigue, irritability, hair thinning, and low thyroid stimulating hormone (TSH) levels. Hyperthyroidism resolved after discontinuing ashwagandha (108745).
Gastrointestinal ...Orally, large doses may cause gastrointestinal upset, diarrhea, and vomiting secondary to irritation of the mucous and serous membranes (3710). When taken orally, nausea and abdominal pain (19276,110490) and gastritis and flatulence (90651) have been reported.
Genitourinary ...In one case report, a 28-year-old male with a decrease in libido who was taking ashwagandha 5 grams daily over 10 days subsequently experienced burning, itching, and skin and mucous membrane discoloration of the penis, as well as an oval, dusky, eroded plaque (3 cm) with erythema on the glans penis and prepuce (32537).
Hepatic ...Orally, ashwagandha in doses of 154-1350 mg daily has played a role in several case reports of liver injury. In most of these cases, other causes of liver injury were excluded, and liver failure did not occur. Symptoms included jaundice, pruritus, malaise, fatigue, lethargy, weight loss, nausea, diarrhea, abdominal pain, stool discoloration, and dark urine. Symptom onset was typically 5-180 days from first intake, although in some cases onset occurred after more than 12 months of use (102686,107372,110490,110491,111533,111535,112111). Laboratory findings include elevated aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase, and serum bilirubin (112111). In most cases, liver enzymes normalized within 1-5 months after discontinuation of ashwagandha (102686,107372,110491,111535,112111). However, treatment with corticosteroids, lactulose, ornithine, ursodeoxycholic acid, and plasmapheresis, among other interventions, was required in one case (111533). Rarely, use of oral ashwagandha has been reported to cause hepatic encephalopathy and liver failure requiring liver transplantation (110490).
Neurologic/CNS ...Orally, ashwagandha has been reported to cause drowsiness (110492). Headache, neck pain, and blurry vision have been reported in a 47-year-old female taking ashwagandha, cannabis, and venlafaxine. Imaging over the course of multiple years and hospital admissions indicated numerous instances of intracranial hemorrhage and multifocal stenosis of intracranial arteries, likely secondary to reversible cerebral vasoconstriction syndrome (RCVS) (112113). It is unclear whether the RCVS and subsequent intracranial hemorrhages were precipitated by ashwagandha, cannabis, or venlafaxine.
General
...Orally and topically, biotin is generally well tolerated.
Most Common Adverse Effects: None.
Gastrointestinal ...Orally, high-dose biotin has been rarely associated with mild diarrhea. Transient mild diarrhea was reported by 2 patients taking biotin 300 mg daily (95662).
Pulmonary/Respiratory ...In one case report in France, a 76-year-old female frequent traveler developed eosinophilic pleuropericarditis after taking biotin 10 mg and pantothenic acid 300 mg daily for 2 months. She had also been taking trimetazidine for 6 years (3914). Whether eosinophilia in this case was related to biotin, pantothenic acid, other substances, or patient-specific conditions is unknown. There have been no other similar reports.
General
...Orally, fo-ti may be unsafe.
Most Common Adverse Effects:
Orally: Abdominal pain, diarrhea, nausea, and vomiting with use of unprocessed fo-ti.
Serious Adverse Effects (Rare):
Orally: Hepatotoxicity with processed or unprocessed fo-ti.
Dermatologic ...Orally, one case of a fine maculopapular rash was reported in a patient taking the herbal product known as Shen-Min, which contains fo-ti. Symptoms resolved within three weeks after discontinuing the product (14482). It is unclear if the rash was due to fo-ti or other ingredients in the herbal product.
Gastrointestinal ...Orally, unprocessed fo-ti may cause diarrhea, abdominal pain, nausea, and vomiting (12,50733).
Hematologic ...Orally, one case of mild eosinophilia was reported in a patient taking the herbal product known as Shen-Min, which contains fo-ti. Symptoms resolved within three weeks after discontinuing the product (14482). It is unclear if this reaction was due to fo-ti or other ingredients in the herbal product. A case of agranulocytosis was reported in a 65-year-old female taking fo-ti 30 grams/day for 17 days. The patient recovered gradually following a 15-day hospitalization, which included treatment with intravenous steroids and granulocyte colony-stimulating factor (112231).
Hepatic
...Orally, cases of liver damage due to both processed and unprocessed fo-ti have been well documented in the medical literature.
(7626,7627,14327,14339,14347,14482,16459,17192,50711,50726)(50727,50729,92892,92895,112231).
In a systematic review, around 450 cases of hepatitis associated with fo-ti were identified. These cases occurred in patients 5-78 years of age. Liver damage occurred at a wide range of doses, formulations, and durations of intake. The type of liver injury ranged from hepatocellular, to cholestatic, or mixed. Outcomes ranged from full recovery to cirrhosis, liver transplantation, and/or death. The evidence suggests that when the daily fo-ti dose is less than 12 grams, the median time to occurrence of liver damage is 60 days. When the daily fo-ti dose is more than 12 grams, the median time to liver damage is 30 days (92895). Presenting signs and symptoms may include jaundice, abdominal pain, nausea, fatigue, loss of appetite, dark urine, myalgias, and elevations in liver function tests (LFTs), ferritin, transferrin, prothrombin time, and INR (17192,92892). Other manifestations may include fever, skin rash, thrombocytopenia, pancytopenia, and arthralgias. Symptoms and increased LFTs usually seem to resolve within a month after discontinuing fo-ti (7626,7627,14339,14347,14482,16459). In one case series, liver enzymes began to normalize 48 hours after discontinuation of fo-ti and treatment with S-adenosylmethionine, compound glycyrrhizin injection, polyene phosphatidylcholine, and reduced glutathione. All patients were eventually discharged home in stable condition (92892). Rechallenge with fo-ti should not be attempted. A patient who had recovered from hepatitis associated with fo-ti use presented with myalgias and markedly elevated LFTs after a single dose of the herb (17192).
It is thought that this idiosyncratic reaction leading to liver damage is at least partially related to genetic polymorphisms. Cytochrome P450 1A2 (CYP1A2) is the predominant enzyme involved in biotransformation of emodin, a constituent of fo-ti thought to play a role in liver damage. In one genetic study, the frequency of CYP1A2*1C mutation in fo-ti induced drug-induced liver injury patients was 46.5%, which is significantly higher than the 27.9% frequency of liver injury reported in healthy patients without the mutation. Patients with a CYP1A2*1C mutation may have decreased activity of the CYP1A2 enzyme, which could inhibit the metabolism of fo-ti, causing an accumulation of toxic substances (92897).
General
...Orally and intravenously, inositol seems to be well tolerated.
Topically, no adverse effects have been reported, although a thorough evaluation of safety outcomes has not been conducted.
Most Common Adverse Effects:
Orally: Diarrhea, gas, and nausea.
Gastrointestinal ...Orally, inositol may cause nausea, diarrhea, gas, and gastrointestinal discomfort (10387,11972,91547,91549,95089,95090,95092).
Immunologic ...Orally, inositol in combination with omega-3 fatty acids has been associated with reports of cold and allergy symptoms in children in clinical research (95092).
Musculoskeletal ...Orally, inositol in combination with omega-3 fatty acids has been associated with reports of tics and other musculoskeletal side effects in children in clinical research (95092).
Neurologic/CNS ...Orally, inositol may cause dizziness, tiredness, insomnia, agitation, and headache (10387,11972,95089,95092). In combination with omega-3 fatty acids, inositol has been associated with reports of feelings of thirst in children in clinical research (95092).
Psychiatric ...In one case report, a 36-year-old male with adequately controlled bipolar disorder was hospitalized with symptoms of mania after consuming several cans of an energy drink containing inositol, caffeine, taurine, and other ingredients (Red Bull Energy Drink) over a period of 4 days (14302). It is not known if this is related to inositol, caffeine, taurine, a different ingredient, or a combination of the ingredients.