Ingredients | Amount Per 1 Softgel: |
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Double Strength Proprietary Formula (Herb/Botanical)
(containing)
(Double Strength Proprietary Formula (Herb/Botanical) Note: containing )
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325 mg |
(Eucalyptus radiata )
(leaf)
(with 50- 70% 1,8 Cineole, < 10% Alpha Pinene, 2- 15% Alpha-Terpineol, and < 10% Limonene)
(Eucalyptus (Eucalyptus radiata) leaf oil (Form: with 50- 70% 1,8 Cineole, 2- 15% Alpha Terpineol, < 10% Alpha Pinene, and < 10% Limonene) PlantPart: leaf Genus: Eucalyptus Species: radiata )
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(Myrtus communis cineole )
(leaf)
(15- 35% 1,8 Cineole, containing 20- 60% Alpha Pinene, and < 20% Limonene)
(Myrtle (Myrtus communis cineole) leaf oil (Form: containing 20- 60% Alpha Pinene, 15- 35% 1,8 Cineole, and < 20% Limonene) PlantPart: leaf Genus: Myrtus Species: communis SubSpecies: cineole )
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(Citrus limon )
(zest)
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extra virgin Olive Oil, Gelatin, Glycerol, Water, Enteric Coating (Form: Cellulose Gum, Ethylcellulose, Medium Chain Triglycerides, purified Water, Talc)
Below is general information about the effectiveness of the known ingredients contained in the product Sinutol Extra Strength. 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 Sinutol Extra Strength. 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. Eucalyptus has Generally Recognized As Safe status (GRAS) for use in foods as a flavoring in the US (4912).
POSSIBLY SAFE ...when eucalyptol, a constituent of eucalyptus oil, is used orally and appropriately. Eucalyptol appears to be safe for up to 12 weeks (13302).
POSSIBLY UNSAFE ...when the undiluted oil is used topically. Prolonged or widespread exposure has caused neurotoxicity (12869). There is insufficient reliable information available about the safety of diluted eucalyptus oil when used topically.
LIKELY UNSAFE ...when the undiluted oil is ingested orally. Ingesting 3.5 mL of undiluted oil can be fatal in adults (12867). There is insufficient reliable information available about the safety of eucalyptus oil when inhaled as aromatherapy or when eucalyptus leaf is used orally in medicinal amounts.
CHILDREN: LIKELY SAFE
when used orally in amounts commonly found in foods.
Eucalyptus has Generally Recognized As Safe (GRAS) status for use in foods in the US (4912).
CHILDREN: LIKELY UNSAFE
when eucalyptus oil is used orally (12867,49002,107493,107495).
...when eucalyptus oil is used topically in infants and young children. There are reports of neurotoxicity in infants and young children exposed to topical eucalyptus oil. In one of these cases, a 12-month-old child was bathed in water containing eucalyptus oil and other essential oils; in another case, a child had a dressing containing eucalyptus oil applied every 2-4 hours daily for 2 days (12868,12869). ...when eucalyptus solutions are inhaled using a vaporizer (49002).
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in amounts commonly found in foods (4912).
There is insufficient reliable information available about the safety of medicinal amounts of eucalyptus oil; avoid using.
LIKELY SAFE ...when used in amounts commonly found in foods. Lemon has Generally Recognized as Safe (GRAS) status in the US (4912).
POSSIBLY SAFE ...when inhaled in amounts used for aromatherapy, short-term. Lemon essential oil has been used with apparent safety as aromatherapy for up to 2 weeks in clinical research (93475,98128,98129). There is insufficient reliable information available about the safety of lemon when used topically, or when used orally or intranasally in medicinal amounts.
PREGNANCY AND LACTATION:
Insufficient reliable information available.
Avoid using in amounts greater than those typically found in foods.
POSSIBLY SAFE ...when myrtle berry is used orally, short term. Myrtle berry powder 2,250 mg daily has been used with apparent safety for up to 5 days (106778). ...when diluted myrtle leaf extract is used topically and appropriately, short term. A paste containing myrtle leaf extract 5% has been used with apparent safety for up to 6 days (98643). Other myrtle leaf extracts have been applied to the face for up to 16 weeks with apparent safety (106780). ...when myrtle leaf extract is used intravaginally and appropriately, short term. Vaginal suppositories containing myrtle leaf extract 10% and leaf essential oil 0.5% have been used with apparent safety for up to three menstrual cycles (98644).
LIKELY UNSAFE ...when the undiluted oil of myrtle leaf is used orally. Myrtle leaf contains cineole. Ingesting more than 10 grams of cineole can result in respiratory failure and collapse (18). There is insufficient reliable information available about the safety of myrtle leaf and branch when used orally. There is also insufficient reliable information available about the safety of myrtle berry when used topically or myrtle berry extract when used orally or topically.
CHILDREN: LIKELY UNSAFE
when myrtle oil is used orally.
Avoid facial contact with myrtle oil preparations which may cause glottal spasm, bronchospasm, asthma-like attacks, or respiratory failure in infants or small children (18).
There is insufficient reliable information available about the safety of myrtle berry or myrtle berry extract when used orally in children.
PREGNANCY AND LACTATION: LIKELY UNSAFE
when used orally (18); avoid using.
Below is general information about the interactions of the known ingredients contained in the product Sinutol Extra Strength. 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, inhaling eucalyptol may reduce the effectiveness of amphetamines.
Details
Animal research suggests that inhaling eucalyptol may reduce the levels of amphetamines in the blood (48987).
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Theoretically, eucalyptus leaf might increase the risk of hypoglycemia.
Details
Animal research suggests that eucalyptus leaf might have hypoglycemic activity, and might have additive effects when used with antidiabetes drugs (12871).
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Theoretically, eucalyptus might increase the levels of CYP1A2 substrates.
Details
In vitro research suggests that eucalyptus oil might inhibit CYP1A2, although this has not been reported in humans (12479).
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Theoretically, eucalyptus might increase the levels of CYP2C19 substrates.
Details
In vitro research suggests that eucalyptus oil might inhibit CYP2C19, although this has not been reported in humans (12479).
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Theoretically, eucalyptus might increase the levels of CYP2C9 substrates.
Details
In vitro research suggests that eucalyptus oil might inhibit CYP2C9, although this has not been reported in humans (12479).
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Theoretically, eucalyptus might increase the levels of CYP3A4 substrates.
Details
In vitro research suggests that eucalyptus oil might inhibit CYP3A4, although this has not been reported in humans (12479).
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Theoretically, inhaling eucalyptol might reduce the effectiveness of pentobarbital.
Details
Animal research suggests that inhaling eucalyptol reduces the level of pentobarbital that reaches the brain (48987).
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Theoretically, taking itraconazole capsules or tablets with a beverage containing lemon might increase the levels and clinical effects of itraconazole.
Details
In one case report, dissolving itraconazole tablets in a small amount of specific beverages containing lemon prior to administration increased the level of itraconazole in a lung transplant patient. In this case, the increased bioavailability was desirable and was likely due to improved tablet dissolution in the acidic beverage (110781).
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Below is general information about the adverse effects of the known ingredients contained in the product Sinutol Extra Strength. 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, diluted eucalyptus oil is generally well tolerated, but the undiluted oil can cause toxicity.
Most Common Adverse Effects:
Orally: Diarrhea, nausea, vomiting.
Topically: Burning, itching, redness, stinging.
Serious Adverse Effects (Rare):
Orally: Signs of toxicity can occur with the undiluted oil at doses as low as 1 mL and include central nervous system depression, shallow respiration, rapid pulse, apnea, coma, and death.
Topically: Prolonged exposure or large amounts of eucalyptus oil can cause agitation, ataxia, drowsiness, muscle weakness, seizures, and slurred speech. The risk of toxicity may be greater in children.
Inhalation (as aromatherapy): Seizures.
Cardiovascular ...Orally, one case of premature ventricular contractions has been reported in a previously healthy 29-year-old male who ingested approximately one ounce of eucalyptus oil (48983).
Dermatologic ...Topically, eucalyptus pollen, leaves, oil, and the constituent eucalyptol can cause contact dermatitis in sensitive people (13303,48931,92856,92858,92859,98497). In some cases, symptoms respond to treatment with topical corticosteroids and tacrolimus (92856). In one case report, transient local redness, burning, and irritation was reported in a 4-year-old child who was bathed in water containing eucalyptus oil. The symptoms resolved within one hour of rinsing the skin with clear water (48983). In a clinical study, treatment with a combination of eucalyptus oil and lemon tea tree oil caused burning, redness, itching, or stinging in up to 20% of the patients. Stinging usually resolved within 10 minutes of application and redness within 30 minutes (19188,98492).
Gastrointestinal ...Orally, eucalyptus oil can cause nausea, vomiting, and diarrhea (48983,48993,48995). Abdominal pain has been reported in a trial of the eucalyptus constituent eucalyptol for inflammatory bowel disease (IBD) (48936).
Immunologic
...A case of IgE-mediated exacerbation of asthma and rhinitis symptoms has been reported in a patient who consumed eucalyptus.
Similar worsening of symptoms occurred when the patient inhaled eucalyptus pollen (48957).
Occupational exposure to eucalyptus may cause allergic dermatitis (98497).
Neurologic/CNS
...Orally, eucalyptus oil can cause central nervous system depression, coma, and status epilepticus (12867,48946,48983).
Topically, orally, and by inhalation, eucalyptus oil has been associated with seizures. A systematic review describes the characteristics of 49 children and 61 adults with seizures associated with various routes of administration. Patients with no seizure history were classified as a eucalyptus oil-induced seizure (EOIS), while patients with a history of seizure or susceptibility to seizure were defined as a eucalyptus oil-provoked seizure (EOPS). In EOIS cases, topical use was reported in 74%, inhalation in 22.5%, and ingestion in 3.5%; for EOPS cases, topical use was reported in 79%, inhalation in 16%, and ingestion in 5%. Generalized tonic-clonic seizures are the most prominent type of seizure in EOIS cases (96%). Among EOPS patients, 37% had focal onset motor seizures with impaired awareness, 24% had focal onset aware motor seizures, 13% had focal to bilateral tonic-clonic seizures, and 26% had generalized onset tonic-clonic seizures (107494). One prospective observational study that was included in this systematic review provided additional details on eucalyptus-induced seizures. This study included 18 reports of EOIS and 28 reports of EOPS in adults and children after topical or inhaled use of eucalyptus oil, either alone or in combination with camphor. The time to seizure onset was 0.5-48 hours after topical application, 2-30 minutes after inhalation, and 0.5-6 hours after ingestion. (105028).
One prospective observational study and one case series have described 20 case reports of seizures occurring in children after ingestion of eucalyptus oil. Most of these seizures are generalized tonic-clonic in nature, occur 15-30 minutes after exposure, and do not reoccur following the discontinuation of eucalyptus oil. Seizures have been reported with both overdoses and therapeutic doses (107493,107495) and include cases of both EOIS and EOPS (107495). Additionally, children appear more likely to require intensive care and mechanical ventilation when compared with adult cases (107494).
A case of fever and headache has been reported in a patient who routinely applied a teaspoon of gel containing eucalyptus extract in his throat or nose to treat sore throat or rhinitis (48946).
General
...Orally, lemon is well tolerated in amounts commonly found in foods.
A thorough evaluation of safety outcomes has not been conducted on the use of larger amounts.
Most Common Adverse Effects:
Orally: Epigastralgia and heartburn with the regular consumption of fresh lemon juice.
Dermatologic ...Topically, the application of lemon oil might cause photosensitivity, due to furocoumarin derivative content. This occurs most often in fair-skinned people (11019).
Gastrointestinal ...Orally, fresh lemon juice, taken as 60 mL twice daily, has been reported to cause gastrointestinal disturbances in 37% of patients in one clinical trial, compared with 8% of patients in the placebo group. Specifically, of the patients consuming lemon juice, 21% experienced heartburn and 8% experienced epigastralgia, compared to 1% and 3%, respectively, in the placebo group (107489).
General
...There is currently a limited amount of information on the adverse effects of oral and intravaginal myrtle.
A thorough evaluation of safety outcomes has not been conducted. Topically, myrtle leaf seems to be generally well tolerated in adults.
Most Common Adverse Effects:
Topically: Dry skin.
Intravaginally: Vaginal irritation and dryness.
Serious Adverse Effects (Rare):
Orally: Hypotension, respiratory failure.
Topically: Bronchial spasm and respiratory failure, most commonly in infants or children.
Cardiovascular ...Orally, very large amounts of undiluted myrtle leaf oil might lead to low blood pressure and circulatory disorders due to the cineole constituent (18).
Dermatologic ...Topically, myrtle leaf extract has been reported to cause dry skin (106777).
Gastrointestinal ...Orally, myrtle berry extract has been reported to cause constipation in infants and young children (106781).
Genitourinary ...Intravaginally, myrtle leaf extract suppositories have been reported to cause vaginal irritation and dryness (98644).
Pulmonary/Respiratory
...Orally, consumption of very large amounts of undiluted myrtle leaf oil might lead to respiratory failure and collapse (18).
Topically, facial contact with myrtle oil preparations may cause glottal or bronchial spasm, asthma-like attacks, or respiratory failure in infants and children (18).