Four softgels contain: Flaxseed Oil 1000 mg • Evening Primrose Oil 500 mg • Bilberry extract 40 mg. Other Ingredients: Safflower Oil, Lecithin (precept 8120), d-Alpha Tocopheryl Acetate, Gelatin, Glycerin, Purified Water, Caramel Powder.
Brand name products often contain multiple ingredients. To read detailed information about each ingredient, click on the link for the individual ingredient shown above.
Below is general information about the effectiveness of the known ingredients contained in the product Tears Again Hydrate. 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 Tears Again Hydrate. 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 and appropriately in amounts commonly found in foods. Bilberry has Generally Recognized As Safe status (GRAS) for use in foods in the US (4912).
POSSIBLY SAFE ...when used orally and appropriately for medicinal purposes. Bilberry fruit extracts have been used with apparent safety in clinical trials at a dose of up to 160 mg daily for up to 6 months (39,40,8139,9739,14280,35472,35510,35512,103190,104192,104195). A higher bilberry extract dose of 1.4 grams daily has been used with apparent safety for up to 4 weeks (104194). Whole bilberries or bilberry juice have also been consumed with apparent safety in quantities of 100-160 grams daily for up to 35 days (35463,91506).
POSSIBLY UNSAFE ...when the leaves are used orally in high doses or for a prolonged period. Death can occur with chronic use of 1.5 gram/kg daily (2).
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in the amounts commonly found in foods.
However, there is insufficient reliable information available about the safety of bilberry when used in medicinal amounts during pregnancy and lactation; avoid using.
LIKELY SAFE ...when used orally and appropriately. Evening primrose oil has been used safely in doses up to 6 grams daily for up to 1 year (7566,7567,8926,12036,20512,49286,49360,109426). There is insufficient reliable information available about the safety of evening primrose oil when used topically. There is also insufficient reliable information available about the safety of evening primrose seed, flower, or leaf when used orally or topically.
CHILDREN: POSSIBLY SAFE
when evening primrose oil is used orally and appropriately, short-term.
In children up to 5 years of age, doses of evening primrose oil up to 3 grams daily have been used safely for 5 months (20512,49273), and 0.5 grams/kg daily has been used safely for 8 weeks (7570). In children up to 12 years of age, doses of 4-6 grams daily have been used safely for 3-5 months (7565,7566,20512,49286). ...when used topically and appropriately, short-term. In children 2-10 years of age, evening primrose oil has been applied to affected areas of the skin twice daily for up to 3 months (96718). There is insufficient reliable information available about the safety of evening primrose seed, flower, or leaf when used orally or topically.
PREGNANCY: POSSIBLY SAFE
when evening primrose oil is used orally and appropriately.
In small studies of evening primrose oil for pre-eclampsia, 4 grams has been used orally daily for up to 10 weeks during pregnancy with apparent safety (1409,20525). Evening primrose oil has also been used safely during the last week of pregnancy to improve cervical ripening (20524,96717), although in one retrospective case series improvement was lacking and there was a trend toward prolonged labor, increased rates of arrest of descent, and increased oxytocin requirements (1411). Evening primrose oil has also been linked to a case report of petechiae and ecchymoses in a newborn infant whose mother took a total of 6.5 grams during the week before giving birth (16303); use with caution, especially in high doses.
LACTATION: POSSIBLY SAFE
when evening primrose oil is used orally.
Supplementation with evening primrose oil during lactation results in the secretion of high levels of the constituent gamma linolenic acid into breast milk (1982); however, this fatty acid is normally present in significant amounts in breast milk (11884).
LIKELY SAFE ...when used orally and appropriately for medicinal purposes, short-term. Flaxseed oil has been used safely in doses up to 2 grams daily for up to 6 months. Higher doses of up to 24 grams daily has been safely used for up to 7 weeks (845,3912,5898,14443,16789,16791,16794,16795,17523,101951,101952,101955).
POSSIBLY SAFE ...when used topically for medicinal purposes, short-term. Flaxseed oil has been used safely on the wrist for up to 4 weeks (25691). ...when used in eye drops twice daily for up to 90 days (101953).
CHILDREN: POSSIBLY SAFE
when used orally and appropriately, short-term.
Some evidence suggests that flaxseed oil, providing 200 mg of alpha-linolenic acid, can be safely used in children for up to 3 months (14443).
PREGNANCY: POSSIBLY SAFE
when used orally and appropriately for medicinal purposes, short-term.
Although flaxseed oil has been used with apparent safety in clinical research in doses of 1-2 grams daily for up to 6 weeks (96432,101957), some population research has found that consuming flaxseed oil during the second and third trimesters of pregnancy is associated with a four-fold increased risk of premature birth (16797).
LACTATION:
Insufficient reliable information available; avoid using.
Below is general information about the interactions of the known ingredients contained in the product Tears Again Hydrate. 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, bilberry fruit extract might increase the risk of bleeding when taken with anticoagulant or antiplatelet drugs.
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Theoretically, bilberry leaf or fruit extract may increase the risk of hypoglycemia when taken with antidiabetes drugs.
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Animal research suggests that bilberry leaf extract might have blood glucose-lowering activity (1264). Also, one small clinical trial in patients with type 2 diabetes shows that taking bilberry fruit extract 470 mg as a single dose prior to an oral glucose tolerance test lowers plasma glucose levels when compared with placebo (91507).
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Theoretically, bilberry fruit extract might decrease levels of drugs metabolized by CYP2E1.
Details
Animal research shows that exposure to small concentrations of bilberry extract in drinking water for around one month increased CYP2E1 activity by 31%. However, exposure over a 2-month period did not increase CYP2E1 activity (103191). This effect has not been reported in humans.
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Theoretically, bilberry fruit extract might reduce the efficacy of erlotinib.
Details
In vitro research suggests that bilberry fruit extract and its constituents, delphinidin and delphinidin-3-O-glucoside, inhibit the activity of erlotinib (97031). This interaction has not been reported in humans.
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Theoretically, evening primrose oil may increase the risk of bleeding if used with anticoagulant or antiplatelet drugs.
Details
Evening primrose oil contains gamma linolenic acid (GLA). There is preliminary clinical evidence that GLA can reduce platelet aggregation and prolong bleeding time (1979).
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Theoretically, evening primrose may increase the levels and clinical effects of CYP2C9 substrates.
Details
In vitro research shows that linoleic acid, a constituent of evening primrose oil, inhibits CYP2C9 (21017).
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Theoretically, concomitant use of lithium with evening primrose oil might decrease lithium levels and effects.
Details
In a case report, a patient on a stable dose of lithium for 10 years experienced a reduction in lithium levels after taking evening primrose oil 500 mg daily. Baseline levels were 0.69 mmol/L, which decreased to 0.37 mmol/L after 2 months and 0.23 mmol/L after 3 months of use. Lithium levels increased within 6 weeks of discontinuing evening primrose oil, to 0.73 mmol/L; no clinical effects were noted (96715).
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Theoretically, evening primrose oil might increase the levels and effects of lopinavir.
Details
In a case report, an HIV patient who took evening primrose oil (Efamol) along with lopinavir/ritonavir experienced an increase in serum levels of lopinavir to 15.2 mg/L. Six weeks after discontinuing evening primrose oil, levels of lopinavir returned to the normal range of 5-10 mg/L. When re-challenged with evening primrose oil for a week, the patient's lopinavir levels increased from 6.69 to 8.11 mg/L. It is suspected that evening primrose oil increases levels of lopinavir by inhibiting cytochrome P450 3A4 (CYP3A4), which metabolizes lopinavir (93578). However, this effect has not been reported in other research.
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Theoretically, taking evening primrose oil with phenothiazines might increase the risk of convulsions.
Details
Evening primrose oil contains gamma-linolenic acid (GLA). There is some concern that taking supplements containing GLA might cause seizures, or lower the seizure threshold, when taken with phenothiazines (88187). In one report, three patients with schizophrenia who had received phenothiazines developed EEG changes suggestive of temporal lobe epilepsy after starting treatment with GLA, although none experienced an actual seizure (21013). In another report, two patients with schizophrenia who were stabilized on phenothiazines developed seizures when evening primrose oil 4 grams daily was added. One of these patients had a prior history of seizures (21010). It is unclear whether evening primrose oil had any additive epileptogenic effects with the phenothiazines; there is no evidence that taking evening primrose oil alone causes seizures (88187).
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Theoretically, using flaxseed oil in combination with anticoagulant or antiplatelet drugs might have additive effects and increase the risk of bleeding.
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Theoretically, combining flaxseed oil with other antihypertensive drugs might have additive effects and increase the risk of hypotension.
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Concomitant use of flaxseed oil and ezetimibe reduces the absorption of alpha-linolenic acid from flaxseed oil.
Details
In one clinical study, concomitant consumption of ezetimibe 10 mg daily with flaxseed oil 2 grams providing 1 gram of alpha-linolenic acid daily blocked the absorption of alpha-linolenic acid, resulting in an overall reduction in alpha-linolenic plasma levels from baseline (96433).
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Below is general information about the adverse effects of the known ingredients contained in the product Tears Again Hydrate. 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, bilberry fruit, juice, and extracts seem to be well tolerated.
Most Common Adverse Effects:
Orally: Dark-colored stools, flatulence, and gastrointestinal discomfort.
Gastrointestinal
...In one small clinical trial, mild-to-moderate flatulence was reported in 33% of patients taking sieved bilberries and concentrated bilberry juice (91506).
However, the patients in this study had ulcerative colitis, and the study lacked a control group, limiting the validity of this finding. In another small clinical study of males with age-related cognitive impairment, temporary adverse gastrointestinal (GI) effects were reported in 13% of patients drinking a combination of bilberry and grape juice. However, the adverse GI effect rate was identical in patients drinking a placebo juice (110641). A post-marketing surveillance report of 2295 patients using bilberry extract (Tegens) found that 1% of patients complained of GI discomfort and less than 1% experienced nausea or heartburn (35500).
Theoretically, fresh bilberry fruit may have laxative effects. One clinical trial noted an increased frequency of bowel movements following the administration of a combination formulation containing aerial agrimony parts, cinnamon quills, powdered bilberry fruit, and slippery elm bark (35462). It is unclear if these effects were due to bilberry, other ingredients, or the combination.
Other ...Orally, bilberry may cause discoloration of feces and the tongue. In one study, a dark-bluish to black discoloration of both the feces and the tongue was observed following consumption of sieved bilberries and concentrated bilberry juice. In one patient, a slight discoloration of the teeth has also been observed (91506). In another study, 50% of patients reported dark green stools after taking bilberry extract 700 mg twice daily for 4 weeks (104194).
General
...Orally and topically, evening primrose oil is generally well tolerated.
There is limited reliable information available regarding the safety or adverse effects of other parts of the plant.
Most Common Adverse Effects:
Orally: Abdominal pain and distention, diarrhea, dyspepsia, flatulence, nausea, and vomiting.
Dermatologic ...Orally, use of evening primrose oil has been associated with reports of skin rash and acne (9156,9794,49338). There is a case report of extensive but transient petechiae and purpuric ecchymoses in a newborn infant whose mother had consumed raspberry leaf tea and a total of 6.5 grams of evening primrose oil orally and vaginally during the week prior to delivery. The infant had a normal platelet count and no signs of hemorrhage, and was discharged healthy at 3 days of age (16303).
Gastrointestinal ...Gastrointestinal complaints, including abdominal pain, distension and fullness, nausea and vomiting, diarrhea, dyspepsia, and flatulence are the most common adverse effects of evening primrose (8926,9794,20533,49188,49286,49339,49365,65864,88184,102556). Often these effects resolve with continued use. Altered taste has also been reported (49339).
Hematologic ...There is preliminary clinical evidence that evening primrose oil can decrease platelet aggregation and prolong bleeding time. In a small study of patients with hyperlipidemia, taking evening primrose oil 3 grams daily for 4 months was associated with a 40% increase in bleeding time, and decreases in ADP- and epinephrine-induced platelet aggregation of 50% and 60% respectively (1979). There is also a case report of diffuse ecchymoses and petechiae in a neonate whose mother had consumed 6.5 grams of evening primrose oil over the week prior to delivery (16303).
Neurologic/CNS
...Cases of dizziness (9794) and headache (88184) have been reported with evening primrose oil when used orally.
There is a report of seizures in a patient taking evening primrose oil and receiving anesthesia; however, the patient was also taking other drugs and it is therefore unclear if evening primrose was the cause (613). There is also concern that evening primrose oil might cause seizures, or lower the seizure threshold, in patients with schizophrenia who are treated with phenothiazines. This is based on limited data from two studies published in the 1980s. In one report, three patients with schizophrenia who had received phenothiazines developed EEG changes suggestive of temporal lobe epilepsy after starting treatment with evening primrose, although none experienced an actual seizure (21013). In the other report, two patients with schizophrenia who were stabilized on phenothiazines developed seizures when evening primrose oil 4 grams daily was added. One of these patients had a prior history of seizures (21010). There is no evidence that evening primrose taken alone, without medications known to lower the seizure threshold, can cause seizures (88187).
Other ...Weight gain has been reported in individuals receiving evening primrose oil (49338).
General
...Orally, flaxseed oil is generally well tolerated.
Topically, flaxseed oil seems to be well-tolerated.
Most Common Adverse Effects:
Topically: Itching, redness.
Serious Adverse Effects (Rare):
Orally: Severe allergic reactions such as anaphylaxis.
Endocrine ...Orally, flaxseed oil might cause gynecomastia. In a case report, a 70-year-old male developed gynecomastia after taking flaxseed oil daily for 3 months. Discontinuing flaxseed oil lead to resolution of gynecomastia (105478).
Gastrointestinal ...Orally, flaxseed oil may cause a change in bowel habits, dry mouth, and dyspepsia when taken at a dose of about 5 grams daily. However, these effects have been reported by only a small number of patients (approximately 3%) (16794). High doses of flaxseed oil (30 grams per day and higher) have been associated with loose stools and diarrhea (5898,11025).
Immunologic ...Severe allergic reactions such as anaphylaxis have been reported with flaxseed oil ingestion and also in workers processing flaxseed products (6809).
Ocular/Otic ...Topically, eye drops containing flaxseed oil may cause redness and itching (101953).
Oncologic ...Flaxseed oil has not been linked to increased prostate cancer risk. Although epidemiologic research has found that high dietary intake of alpha-linolenic acid (ALA) is associated with increased prostate cancer risk (1337,2558,7147,7823,12978), this risk does not seem to apply to ALA from plant sources, like flaxseed (12909).
