Below is general information about the effectiveness of the known ingredients contained in the product Hadas Baby Cal Syrup. 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 Hadas Baby Cal Syrup. 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. Caraway has Generally Recognized as Safe (GRAS) status in the US (4912).
POSSIBLY SAFE ...when caraway oil is used orally in medicinal amounts. Caraway oil has been used with apparent safety at a dose of up to 150 mg daily for up to 4 weeks, in combination with peppermint oil (6740,6741,6742,10075,96344). ...when caraway seed is used orally, short-term. An aqueous caraway seed extract has been used with apparent safety at a dose of 3 grams daily for up to 3 months (94086,94087,94088). ...when used topically and appropriately. A heated poultice containing caraway oil 2% has been used with apparent safety for up to 3 weeks (94085).
PREGNANCY: POSSIBLY UNSAFE
when used in medicinal amounts (4912,6746).
Caraway oil has been used to stimulate menstruation (6746); avoid using.
LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when used orally in amounts commonly found in foods. Fennel has Generally Recognized as Safe (GRAS) status in the US (4912).
POSSIBLY SAFE ...when fennel essential oil or extract is used orally and appropriately, short-term. Twenty-five drops (about 1.25 mL) of fennel fruit extract standardized to fennel 2% essential oil has been safely used four times daily for 5 days (49422). Also, two 100 mg capsules each containing fennel 30% essential oil standardized to 71-90 mg of anethole has been safely used daily for 8 weeks (97498). Powdered fennel extract has been used with apparent safety at a dose of 800 mg daily for 2 weeks (104199). ...when creams containing fennel 2% to 5% are applied topically (49429,92509).
CHILDREN: POSSIBLY SAFE
when combination products containing fennel are used to treat colic in infants for up to one week.
Studied products include up to 20 mL of a fennel seed oil emulsion; a specific product (ColiMil) containing fennel 164 mg, lemon balm 97 mg, and German chamomile 178 mg; and up to 450 mL of a specific tea (Calma-Bebi, Bonomelli) containing fennel, chamomile, vervain, licorice, and lemon balm (16735,19715,49428).
PREGNANCY: POSSIBLY UNSAFE
when used orally.
Observational research has found that regular use of fennel during pregnancy is associated with shortened gestation (100513).
LACTATION: POSSIBLY UNSAFE
when used orally.
Case reports have linked consumption of an herbal tea containing extracts of fennel, licorice, anise, and goat's rue to neurotoxicity in two breast-feeding infants. The adverse effect was attributed to anethole, a constituent of fennel and anise (16744). However, levels of anethole were not measured in breastmilk, and the herbal tea was not tested for contaminants. Furthermore, other adverse effects related to use of fennel during lactation have not been reported. However, until more is known, avoid using.
LIKELY SAFE ...when used orally in amounts commonly found in foods. Roman chamomile has Generally Recognized as Safe (GRAS) status in the US (4912).
POSSIBLY SAFE ...when used topically as a 2% gel for up to 4 weeks (107369). ...when the essential oil is inhaled or used topically as aromatherapy (7107). There is insufficient reliable information available about the safety of Roman chamomile when used orally in amounts greater than those found in foods.
PREGNANCY: LIKELY UNSAFE
when used orally in medicinal amounts.
Roman chamomile is believed to be an abortifacient (4). Some population research has found a possible link between the use of Roman chamomile and an increased incidence of reduced birth weight, threatened miscarriage, and preterm labor (97292). There is insufficient reliable information available about the safety of the topical use of Roman chamomile during pregnancy; avoid using.
LACTATION:
Insufficient reliable information available; avoid using (4).
Below is general information about the interactions of the known ingredients contained in the product Hadas Baby Cal Syrup. 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, caraway might increase the risk of hypoglycemia when used with antidiabetes drugs.
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Theoretically, caraway might increase the effects and adverse effects of CNS depressants.
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Animal research suggests that (S)-(+)-carvone, a major constituent of caraway seed extract, has sedative effects (39800).
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Theoretically, caraway might increase the levels and clinical effects of CYP1A1 substrates.
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In vitro evidence suggests that caraway extract can inhibit the activity of CYP1A1 in a dose-dependent manner (39780). This interaction has not been reported in humans.
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Theoretically, caraway might increase the risk of hypokalemia when used with diuretics that deplete potassium.
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Animal research suggests that a single dose of caraway fruit extract can promote diuresis and increase the urinary excretion of sodium and potassium. However, sub-chronic use of caraway fruit extract does not seem to significantly increase potassium excretion, although urine output continues to be increased for up to 6 days (39797).
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Theoretically, caraway might increase the effects and adverse effects of isoniazid.
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Animal research suggests that a specific fraction of caraway seed extract (CC-1a) can increase plasma levels of isoniazid when administered concomitantly (25529). This interaction has not been reported in humans.
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Theoretically, caraway might reduce excretion and increase levels of lithium due to diuretic effects.
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Animal research suggests that caraway fruit extract has diuretic properties (39797).
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Theoretically, caraway might increase the effects and adverse effects of pyrazinamide.
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Animal research suggests that a specific fraction of caraway seed extract (CC-1a) can increase plasma levels of pyrazinamide when administered concomitantly (25529). This interaction has not been reported in humans.
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Theoretically, caraway might increase the effects and adverse effects of rifampin.
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Animal research suggests that a specific fraction of caraway seed extract (CC-1a) can increase plasma levels of rifampin when administered concomitantly (25529). This interaction has not been reported in humans.
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Theoretically, fennel might increase the risk of bleeding when used with antiplatelet or anticoagulant drugs.
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Theoretically, fennel might decrease the levels and clinical effects of ciprofloxacin.
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Animal research shows that fennel reduces ciprofloxacin bioavailability by nearly 50%, possibly due to the metal cations such as calcium, iron, and magnesium contained in fennel. This study also found that fennel increased tissue distribution and slowed elimination of ciprofloxacin (6135). |
Theoretically, taking large amounts of fennel might decrease the effects of contraceptive drugs due to competition for estrogen receptors.
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Theoretically, fennel might increase levels of drugs metabolized by CYP3A4.
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Theoretically, taking large amounts of fennel might interfere with hormone replacement therapy due to competition for estrogen receptors.
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Theoretically, taking large amounts of fennel might decrease the antiestrogenic effect of tamoxifen.
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Some constituents of fennel have estrogenic activity (11), which may interfere with the antiestrogenic activity of tamoxifen. |
Below is general information about the adverse effects of the known ingredients contained in the product Hadas Baby Cal Syrup. 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, caraway oil seems to be well tolerated.
Gastrointestinal ...Orally, caraway oil, when used in combination with peppermint oil, may cause a substernal burning sensation, belching, nausea, and vomiting (6741,6742,10075,96344). It is unclear if these adverse effects are due to caraway oil, peppermint oil, or the combination. Peppermint oil, when used alone, has been reported to cause similar adverse effects.
Immunologic ...Orally, an allergic reaction has been reported after use of caraway oil in combination with peppermint oil in a patient with a history of bronchial asthma (96344). It is unclear if this adverse effect is due to caraway oil, peppermint oil, or the combination.
General
...Orally and topically, fennel seems to be well tolerated.
Most Common Adverse Effects:
Orally: Gastrointestinal discomfort, photosensitivity, and allergic reactions in sensitive individuals.
Serious Adverse Effects (Rare):
Orally: Seizures.
Dermatologic ...Advise patients to avoid excessive sunlight or ultraviolet light exposure while using fennel (19). Allergic reactions affecting the skin such as atopic dermatitis and photosensitivity may occur in patients who consume fennel (6178,49507).
Gastrointestinal ...Orally, fennel may cause gastrointestinal complaints, including nausea and vomiting (19146,104196).
Hematologic ...Methemoglobinemia has been reported in four infants following intoxication related to ingestion of a homemade fennel puree that may have been made from improperly stored fennel (49444).
Immunologic ...A case report describes an 11-year-old male who developed an allergy to fennel-containing toothpaste. Immediately after using the toothpaste, the patient experienced sneezing, coughing, itchy mouth, rhinorrhea, nasal congestion, wheezing, difficulty breathing, and palpitations, which resolved within 10 minutes of spitting out the toothpaste and rinsing the mouth. In challenge tests, the patient reacted to chewing fresh fennel root, but not ground fennel seeds (103822).
Neurologic/CNS ...Orally, fennel oil has been associated with tonic clonic and generalized seizures (12868). New-onset cluster headaches are reported in a 24-year-old female while using a toothpaste containing fennel and camphor for 3 months. The headaches resolved upon stopping the toothpaste (112368). It is unclear if this adverse effect can be attributed to fennel, camphor, or the combination.
Pulmonary/Respiratory ...Orally, fennel and fennel seed have been reported to cause bronchial asthma (49478).
General
...Roman chamomile is generally well tolerated.
Most Common Adverse Effects:
Topically: Allergic skin reactions.
Dermatologic ...Topically, Roman chamomile can cause contact dermatitis (4,567,97292). Allergic skin reactions can occur in up to 20% of individuals exposed to Roman chamomile (19). Multiple case reports have described the development of topical allergic reactions, including eczema and rash, with the use of cleaning products and cosmetics containing chamomile oil or chamomile extract (97292). In one case report, a 55-year-old man experienced disseminated erythroderma with itchy, scaly lesions after non-contact exposure to an area containing many plant varieties. Patch testing confirmed the presence of allergenicity to Roman chamomile (97292).
Gastrointestinal ...Orally, large amounts of Roman chamomile might cause vomiting, although data are conflicting (11,12).
Immunologic ...Allergic skin reactions can occur in up to 20% of individuals exposed to Roman chamomile (19). Cross-sensitivity can occur in individuals with sensitivity to the Asteraceae/Compositae family (19,97292). Multiple case reports have described the development of topical and respiratory allergic reactions with the use of cleaning products and cosmetics containing chamomile oil or chamomile extract (97292).
Pulmonary/Respiratory ...A case report describes the development of cough and rhinitis in a 20-year-old female after exposure to chamomile-scented toilet paper. Skin prick testing confirmed the presence of allergenicity to the toilet paper product (97292).