NatraBio Children's Cough Syrup by Nutraceutical Corp.

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Asthma. Although there is interest in using oral belladonna for asthma, there is insufficient reliable information about the effects of belladonna for this condition.
• Common cold. Although there is interest in using oral belladonna for the common cold, there is insufficient reliable information about the effects of belladonna for this condition.
• Hemorrhoids. Although there is interest in using rectal belladonna for hemorrhoids, there is insufficient reliable information about the effects of belladonna for this condition.
• Irritable bowel syndrome (IBS). It is unclear if oral belladonna is beneficial in patients with IBS. Details: A prescription-only oral combination of belladonna and phenobarbital, first marketed prior to the passing of the Food, Drug, and Cosmetic Act of 1938, is considered an unapproved drug, but is allowed to remain on the market while the FDA evaluates its effectiveness and safety (106908). However, preliminary clinical research suggests that taking a combination of belladonna and phenobarbital orally for one month does not improve symptoms of IBS when compared with placebo (34156).
• Kidney stones (nephrolithiasis). It is unclear if rectal belladonna is beneficial in patients with ureteral spasm associated with kidney stones. Details: A prescription-only rectal combination of belladonna and opium, first marketed prior to the passing of the Food, Drug, and Cosmetic Act of 1938, is considered an unapproved drug, but is allowed to remain on the market while the FDA evaluates its effectiveness and safety (106909). Clinical trials for this indication have not been published, and clinical data are not included in the package insert.
• Parkinson disease. Although there is interest in using oral belladonna for Parkinson disease, there is insufficient reliable information about the effects of belladonna for this condition.
• Rheumatoid arthritis (RA). Although there is interest in using topical belladonna for RA, there is insufficient reliable information about the effects of belladonna for this condition. More evidence is needed to rate belladonna for these uses.

(Read more about BELLADONNA)

There is insufficient reliable information available about the effectiveness of bryonia.

(Read more about BRYONIA)

POSSIBLY INEFFECTIVE

• Poisoning. Historically, ipecac syrup was commonly used to manage poisoning (15,56380,56387,56403,56415). However, the American Academy of Pediatrics, American Academy of Clinical Toxicologists, and European Association of Poisons Centres and Clinical Toxicologists state that ipecac should not be used routinely for poisoning due to a lack of evidence of improved outcomes over available alternatives and an increased risk for adverse consequences (11349,12394,56389). Research shows that inducing emesis with oral ipecac syrup within 10 minutes of poison ingestion can remove 28% to 54% of the poison dose from the patient (56408,56419,56455). However, as the interval between poison ingestion and ipecac-induced emesis is extended, the percentage of poison dose recovered declines, approaching zero after 90 minutes (56454,56466). Furthermore, ipecac syrup does not appear to be more effective than activated charcoal (103744). While some research shows that taking 30 mL of ipecac syrup within one hour of poison ingestion can reduce absorption of poisons by about the same amount as taking 50-60 grams of activated charcoal (56411), most research shows that ipecac syrup is less effective than activated charcoal (56427,56442,56444). Also, using ipecac followed by activated charcoal after cessation of vomiting does not provide any benefit over earlier administration of activated charcoal alone (56403,56451,103744), and may increase patient recovery times (56392). Finally, there are also adverse consequences of ipecac use, including an increased risk for aspiration pneumonia and the need to delay administration of activated charcoal, poison-specific oral antidotes, or fluids for whole bowel irrigation after ipecac administration in order to avoid emesis of these treatments (12394,56392,56406,56444,103744). There is insufficient reliable information available about the effectiveness of ipecac for its other uses.

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INSUFFICIENT RELIABLE EVIDENCE to RATE

• Aging skin. It is unclear if a topical thyme flower and leaf extract reduces wrinkles. Details: A small clinical trial in healthy females aged 40-60 years with wrinkles shows that applying a specific gel preparation (ThymLec 2%, PhytoPharmaTech) containing thyme flower and leaf 1-3% extract in lecithin on the face twice daily for 60 days reduces facial wrinkles when compared with inactive control gel, but not when compared with an active comparator gel containing propanediol, ornithine, phospholipids, and glycolipids (105909).
• Alopecia areata. Topical thyme oil has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: One small clinical study shows that applying a combination of the essential oils from thyme, rosemary, lavender, and cedarwood improves hair growth in up to 44% of patients after 7 months of treatment when compared with baseline (5177). The validity of this finding is limited by the lack of a comparator group. Additionally, it is unclear if this effect is due to thyme, other ingredients, or the combination.
• Bronchitis. Oral thyme has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Some research has evaluated thyme in combination with cowslip. One observational study in adults and children has found that taking a specific product (Bronchipret) containing thyme and cowslip relieves symptoms of bronchitis and increases production of sputum (13557). A clinical study in patients with acute bronchitis shows that taking a similar combination extract (Bronchicum Tropfen) containing thyme and cowslip root 1 mL five times daily for 7-9 days seems to reduce severity and duration of coughing when compared with placebo (49219). Other thyme and cowslip preparations such as Bronchicum Elixir S and Bronchcium Tropfen seem to be similarly beneficial for bronchitis (49223). Thyme has also been studied in combination with other ingredients. A large clinical study in patients with acute bronchitis shows that taking a specific syrup (Bronchipret Saft, Bionorica AG) containing thyme and English ivy leaf 5.4 mL three times daily for 11 days reduces the frequency and duration of cough when compared with placebo (78152). Additionally, an observational study in children with acute bronchitis has found that taking this combination product in an age-specific dosing schema is associated with reduced bronchitis severity and coughing fits when compared to baseline (78181). However, due to the lack of a comparator group, it is unclear if these changes are due to the product or to the natural resolution of the condition.
• Colic. Although there is interest in using oral thyme for colic, there is insufficient reliable information about the clinical effects of thyme for this condition.
• Cough. Oral thyme has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A large open-label, uncontrolled study in adults with acute cough due to an upper respiratory tract infection who purchased a specific syrup (Bronchipret drops, Bionorica AG) containing thyme and English ivy leaf extracts suggests that taking this product as 2.6 mL three times daily for at least 4 days may improve patient-reported bronchitis symptom severity, cough severity, and quality of life, with over 90% of patients reporting overall satisfaction and product tolerability (110401). However, due to the lack of a comparator group, it is unclear if these changes are due to the product or the natural resolution of the condition. Additionally, the validity of these findings is limited by poor study methodology.
• Common cold. Although there is interest in using oral thyme for the common cold, there is insufficient reliable information about the clinical effects of thyme for this condition.
• Dementia. It is unclear if aromatherapy with thyme oil is beneficial in patients with dementia. Details: One very small clinical study in patients with advanced dementia shows that attaching a pad containing thyme oil to the collar area of the shirt does not reduce agitation when compared with lavender oil or unscented grapeseed oil (12213).
• Developmental coordination disorder (DCD). Oral thyme oil has only been evaluated in combination with other oils; its effect when used alone is unclear. Details: One very small clinical study in children with DCD shows that taking thyme oil, in combination with evening primrose oil, fish oil, and vitamin E (Efalex, Efamol Ltd.), seems to modestly improve movement disorders when compared with baseline (5708). The validity of this finding is limited by the lack of a comparator group. Additionally, it is unclear if this effect is due to thyme, other ingredients, or the combination.
• Dyspepsia. Although there is interest in using oral thyme for dyspepsia, there is insufficient reliable information about the clinical effects of thyme for this condition.
• Dysmenorrhea. It is unclear if drinking thyme tea is beneficial for the prevention of dysmenorrhea. Details: One small observational study in adolescents living in Ethiopia has found that drinking thyme tea is associated with a lower occurrence of primary dysmenorrhea when compared with those who did not drink thyme tea (105910).
• Halitosis. It is unclear whether oral thyme is beneficial for halitosis. Details: One small retrospective study in adults with gingival halitosis who received periodontal treatment and oral hygiene instructions suggests that drinking thyme tea twice daily for 1 week is associated with a reduction in volatile sulfur compounds, which is a marker for halitosis, when compared with chlorhexidine or oral hygiene alone (111716). However, the interpretation of this finding is limited by the lack of thyme dosing information and the narrow focus on intraoral halitosis, excluding most extraoral halitosis-associated conditions.
• Laryngitis. Although there is interest in using oral and topical thyme for laryngitis, there is insufficient reliable information about the clinical effects of thyme for this condition.
• Oral mucositis. Although there is interest in using oral and topical thyme for oral mucositis, there is insufficient reliable information about the clinical effects of thyme for this condition.
• Tonsillitis. Although there is interest in using oral and topical thyme for tonsillitis, there is insufficient reliable information about the clinical effects of thyme for this condition. More evidence is needed to rate thyme for these uses.

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POSSIBLY UNSAFE ...when used rectally. It is not known whether significant amounts of the toxic alkaloids are absorbed from the rectum (106909). ...when used topically. It is not known whether significant amounts of the toxic alkaloids are absorbed through the skin (106909).

LIKELY UNSAFE ...when used orally. Belladonna contains toxic alkaloids and has been linked to reports of serious adverse effects (12,553,34144).

CHILDREN: LIKELY UNSAFE
when used orally. Fatalities in children may occur at doses of belladonna providing atropine 0.2 mg/kg (34168). Two belladonna berries, which contain 2 mg atropine per fruit, may be lethal for a small child (34144). Severe adverse effects and fatalities have been reported in infants treated with topical homeopathic teething products containing belladonna (17493,34142,34146,93537).

PREGNANCY: LIKELY UNSAFE
when used orally. Belladonna contains toxic alkaloids and has been linked to reports of serious adverse effects (12,553,34144).

LACTATION: LIKELY UNSAFE
when used orally. Belladonna can reduce milk production and is secreted into breast milk (15).

(Read more about BELLADONNA)

LIKELY UNSAFE ...when the root or berries are used orally (2,18). Consuming 40 berries might be fatal (18).

CHILDREN: LIKELY UNSAFE
when the root or berries are used orally (2,18). Consuming as few as 15 berries can be fatal in children (18).

PREGNANCY: UNSAFE
when the root is used orally. Bryonia root might have abortifacient effects (2). ...when the berries are used orally (2).

LACTATION: LIKELY UNSAFE
when the root or berries are used orally (2).

(Read more about BRYONIA)

POSSIBLY SAFE ...when the rhizome or syrup of ipecac is used orally and appropriately, as a single dose. A single 15-30 mL dose of syrup containing 10-21 mg ipecac has been used with apparent safety in clinical research (12,56419,103744).

POSSIBLY UNSAFE ...when in contact with skin or when inhaled. The constituent emetine is a skin irritant, and ipecac powder is a respiratory irritant (6,18).

LIKELY UNSAFE ...when used orally long-term or in amounts greater than 30 mL. Misuse can lead to serious toxicity, including cardiomyopathy and death. Chronic ingestion of ipecac 30 mL (21 mg) 2-3 times daily for 5 months has been associated with cardiomyopathy. The acute lethal dose of ipecac is 850-1780 mL (600-1250 mg) (6,12,19,56412,56460,56467). ...when a total dose of more than 1 gram is injected, it can cause nervous system symptoms, blood in the urine, and circulatory collapse (6).

CHILDREN: POSSIBLY SAFE
when used orally and appropriately as an emetic (272,11349).

CHILDREN: LIKELY UNSAFE
when used orally in large doses and in infants under 1 year old (12,19). Children are more sensitive to large doses and effects on the nervous system than adults (19).

PREGNANCY: LIKELY UNSAFE
when used orally; ipecac is a potential uterine stimulant (12,19).

LACTATION:
Insufficient reliable information available; avoid using.

(Read more about IPECAC)

LIKELY SAFE ...when used in amounts commonly found in foods. Thyme has Generally Recognized as Safe (GRAS) status in the US (4912).

POSSIBLY SAFE ...when thyme is used orally and appropriately in supplemental amounts. Orally, thyme, in combination with other herbs, has been used safely for up to 23 days (13557,49219,49223,78133). ...when diluted thyme oil is used topically, short-term. Diluted thyme oil has been used with apparent safety for up to 7 months (5177). There is insufficient reliable information available about the safety of thyme oil when used orally or when inhaled.

CHILDREN: LIKELY SAFE
when used in amounts commonly found in foods. Thyme has Generally Recognized as Safe (GRAS) status in the US (4912).

CHILDREN: POSSIBLY SAFE
when thyme is used orally in medicinal amounts in combination with English ivy. Thyme has been used with apparent safety in combination with English ivy for up to 10 days (78181). There is insufficient reliable information available about the safety of thyme oil when used orally or topically in children.

PREGNANCY AND LACTATION: LIKELY SAFE
when used in amounts commonly found in foods. Thyme has Generally Recognized as Safe (GRAS) status in the US (4912). There is insufficient reliable information available about the safety of thyme when used in medicinal amounts during pregnancy and breast-feeding; avoid using.

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ANTICHOLINERGIC DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = D Belladonna may increase the risk of adverse effects when used concomitantly with anticholinergic drugs.  Details Belladonna has anticholinergic activity and increases the activity of anticholinergic drugs (2,12).

CISAPRIDE (Propulsid) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, belladonna might reduce the effects of cisapride.  Details Belladonna contains atropine. In vivo evidence suggests that atropine can prevent cisapride from increasing motility in the gastrointestinal tract (25191).

(Read more about BELLADONNA)

(Read more about BRYONIA)

(Read more about IPECAC)

ANTICHOLINERGIC DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, concurrent use of anticholinergic drugs and thyme essential oil might reduce the effects of anticholinergic drugs.  Details In vitro evidence suggests that thyme essential oil and specific essential oil constituents like thymohydroquinone and carvacrol can inhibit acetylcholinesterase (AChE) (78155). However, this effect has not been observed in humans.

ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, thyme leaf extract might have additive effects with anticoagulant or antiplatelet drugs.  Details In vitro and animal research suggests that thyme leaf extract has antiplatelet effects (13457,18335,49445). However, this effect has not been observed in humans.

CHOLINERGIC DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, concurrent use of cholinergic drugs and thyme essential oil might cause additive cholinergic effects.  Details In vitro evidence suggests that thyme essential oil and specific essential oil constituents like thymohydroquinone and carvacrol can inhibit acetylcholinesterase (AChE) (78155). However, this effect has not been observed in humans.

ESTROGENS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, thyme might competitively inhibit the effects of estrogen replacement therapy.  Details In vitro research shows that thyme has estrogen receptor-binding activity and phytoestrogen content (3701). However, this effect has not been observed in humans.

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General ...Orally, belladonna can cause anticholinergic side effects even at low doses, and is considered poisonous.
Most Common Adverse Effects:
Orally: Anticholinergic side effects, including blurred vision, constipation, delirium, dilated pupils, dizziness, dry mouth, fever, headache, hypertension, muscle rigidity and tremor, psychosis, respiratory failure, and slurred speech.

Cardiovascular ...Orally, belladonna can cause anticholinergic side effects such as hypertension, hypotension, tachycardia, and ventricular premature beats (553,34168,34180).

Dermatologic ...Orally, belladonna can cause anticholinergic side effects such as dry, red skin and decreased perspiration (553,34146,34152). One case of rash and another case of hives have been reported in patients taking belladonna with phenobarbital and ergotamine orally; it is unclear if the adverse effects were due to belladonna or the other ingredients (34154).
Topically, belladonna plaster (Cuxon Gerrard) can cause contact dermatitis (34152).

Gastrointestinal ...Orally, belladonna can cause anticholinergic side effects such as dry mouth and constipation (553,34162,34163,34176,34180,34181).

Genitourinary ...Orally, belladonna can cause anticholinergic side effects such as urinary retention (553,34145,34150,34163).

Neurologic/CNS ...Orally, belladonna can cause anticholinergic side effects such as memory and attention impairment, headache, and confusion (553,34163,34180).

Ocular/Otic ...Orally and topically, belladonna can cause anticholinergic side effects such as dilation of pupils and blurred vision (553,34157,34168,34169,34180). A case report describes anisocoria (unequal pupil sizes) in a 70-year-old female who used homeopathic pink eye relief drops (Similasan) containing belladonna, eyebright, and hepar sulphuris (calcium sulfide) in one eye for 3 days. The pupil dilation lasted more than 2 weeks and did not respond to bright light or pilocarpine (106907). Another report describes a case of acute angle closure glaucoma, requiring referral to an ophthalmologist, in a 55-year-old female who used these eye drops for 2 days (106906).

(Read more about BELLADONNA)

General ...Orally, bryonia root can cause dizziness, vomiting, convulsions, colic, bloody diarrhea, abortion, nervous excitement, and kidney damage. Large doses of bryonia can cause anuria, collapse, paralysis, and death (2). Bryonia berries can be fatal when taken orally; 40 berries can be fatal in adults, and 15 berries can be fatal in children (18).
Topically, skin contact with fresh bryonia may cause irritation (19).

Dermatologic ...Topically, skin contact with fresh bryonia may cause irritation (19).

Gastrointestinal ...Orally, bryonia root can cause vomiting, colic, and bloody diarrhea (2).

Genitourinary ...Orally, bryonia root can cause abortion (2). Large doses of bryonia can cause anuria and death (2).

Musculoskeletal ...Orally, large doses of bryonia can cause paralysis and death (2).

Neurologic/CNS ...Orally, bryonia root can cause dizziness, convulsions, and nervous excitement (2). Large doses of bryonia can cause paralysis and death (2).

Renal ...Orally, bryonia root can cause kidney damage (2). Large doses of bryonia can cause anuria and death (2).

Other ...Orally, bryonia berries can be fatal. Consuming 40 berries can be fatal in adults and as few as 15 berries can be fatal in children (18).

(Read more about BRYONIA)

General ...Orally, ipecac syrup can cause nausea, vomiting, diarrhea, GI irritation, dizziness, hypotension, dyspnea, and tachycardia. Rarely, it can also cause intracerebral hemorrhage, pneumomediastinum, retropneumoperitoneum, esophageal bleeding (3,6,11,13,15,18,56390,56440,56447,56448)(56449,56464). Chronic use is associated with myopathies and death (6,18,56391,56412,56413,56414,56416,56421,56422,56424)(56433,56441,56446,56459,56462,56467). Overdose is associated with erosion of GI tract mucous membranes, cardiac arrhythmias, disorders of respiratory function, convulsions, shock, and coma (18).
Topically, emetine is a skin irritant (6).
When inhaled, ipecac powder is a respiratory irritant and can result in allergic symptoms such as rhinitis, as well as aspiration pneumonitis (18,56406,56445).
Intravenously, emetine may cause inflammation of the muscle tissue at the injection site with chronic administration. In total doses over 1 gram, it can lead to gastrointestinal and nervous system symptoms, hematuria and circulatory collapse (6).

Cardiovascular ...Orally, ipecac can cause hypotension, dyspnea, and tachycardia (11,56440). Chronic use is associated with cardiac myopathy and death related to heart failure (6,18,56391,56409,56424,56467). Overdose is associated with shock and cardiac arrhythmias (18).
Intravenously, ipecac in total doses over 1 gram can lead to circulatory collapse (6).

Dermatologic ...Topically, emetine, a constituent of ipecac syrup, is a skin irritant (6).

Gastrointestinal ...Orally, ipecac causes nausea, vomiting, diarrhea, and GI irritation (3,6,11,13,15,18,56390,56464). In some cases, these adverse effects are severe. There is a case report of a pneumomediastinum (air in the membrane around the heart) and retropneumoperitoneum (air behind the chest cavity) indicative of esophageal rupture following administration of a therapeutic dose of ipecac (56448). There is also a case report of esophageal bleeding following therapeutic use of ipecac (56447). Overdose is associated with erosion of GI tract mucous membranes (18).
Intravenously, ipecac in total doses over 1 gram can lead to gastrointestinal symptoms (6).

Hematologic ...Orally, a case of intracerebral hemorrhage related to the use of ipecac syrup has been reported in an elderly patient (56449).

Immunologic ...When inhaled, ipecac powder has resulted in occupational allergy symptoms, such as rhinitis (56445).

Musculoskeletal ...Orally, progressive muscular weakness has occurred following ipecac abuse, in some cases resulting in death. Discontinuation of ipecac seems to reverse the myopathy (56391,56412,56413,56414,56416,56421,56422,56424,56433,56441)(56446,56459,56462).
Intravenously, emetine may cause inflammation of the muscle tissue at the injection site with chronic administration (6).

Neurologic/CNS ...Orally, ipecac may cause dizziness (11). Overdose is associated with convulsions and coma (18).
Intravenously, ipecac in total doses over 1 gram can lead to nervous system symptoms (6).

Pulmonary/Respiratory ...Orally, ipecac causes dyspnea (11). Overdose is associated with disorders of respiratory function (18).
When inhaled, ipecac powder is a respiratory irritant and can result in aspiration pneumonitis (18,56406).

Renal ...Intravenously, ipecac in total doses over 1 gram can lead to hematuria (6).

(Read more about IPECAC)

General ...Orally, thyme is well tolerated when used in food and seems to be well tolerated when used medicinally. Topically, thyme seems to be generally well tolerated.
Most Common Adverse Effects:
Orally: Allergic reactions, diarrhea, dizziness, headache, heartburn, nausea, or vomiting.
Topically: Contact dermatitis and skin irritation.

Dermatologic ...Topically, thyme, thyme oil, or the constituent thymol can cause contact dermatitis and skin irritation (13463,78252,78362,78384,77982,78154,78310,78313,78384). In one study of 100 patients with contact allergies, 5% were attributed to thyme oil as an allergen contained in wound dressings (78362). Toothpastes containing thymol have been associated with cheilitis and glossitis (13463).

Gastrointestinal ...Orally, thyme and thyme oil may cause heartburn, nausea, vomiting, stomach upset, or diarrhea (13557,94033). In a clinical study, two patients using extracts of thyme herb and ivy leaves experienced temporary stomach ache and mild nausea (78181).
Intravaginally, cream containing thyme and garlic has been associated with reports of nausea and vomiting in one clinical study (88387). It is not clear if these adverse effects were associated with thyme, garlic, or the combination.

Genitourinary ...Intravaginally, cream containing thyme and garlic has been associated with reports of vaginal dryness and vaginal irritation in one clinical study (88387). It is not clear if these adverse effects were associated with thyme, garlic, or the combination.

Immunologic ...Orally, thyme can cause allergic reactions; however, this is uncommon (13463). Allergic reactions to thyme might be more common in people who are also allergic to oregano and other Lamiaceae species (3808).

Neurologic/CNS ...Orally, thyme may case headache or dizziness (94033).

Pulmonary/Respiratory ...By inhalation, occupational exposure to thyme dust can cause acute airway obstruction (783,13463,13464,77982,78098).

(Read more about THYME)