| Ingredients | Amount Per Serving |
|---|---|
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Calories
|
0 Calorie(s) |
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Total Carbohydrates
|
<1 Gram(s) |
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Total Sugars
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0 Gram(s) |
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Added Sugars
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0 Gram(s) |
| <1 Gram(s) | |
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(Lactobacillus rhamnosus )
(10 billion CFU)
(Lactobacillus rhamnosus GG Genus: Lactobacillus Species: rhamnosus Note: 10 billion CFU )
|
53 mg |
Xylitol, Stearic Acid (Alt. Name: C18:0), Microcrystalline Cellulose, Natural flavors, Magnesium Stearate, Malic Acid, Citric Acid
Below is general information about the effectiveness of the known ingredients contained in the product Digestive Daily Probiotic Chewables Fresh Orange Flavor. 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
Below is general information about the safety of the known ingredients contained in the product Digestive Daily Probiotic Chewables Fresh Orange Flavor. 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. Lacticaseibacillus rhamnosus has been safely used alone or in combination with other probiotics in studies lasting up to 6 months (4367,12108,35393,105134,107569,107572,107573,107575,107577,111793)(111996,111997,111998,112493,112496,112503,112508). ...when used intravaginally and appropriately. L. rhamnosus has been used safely in studies lasting from one week to six months (4397,12108,90283,111999). There is insufficient reliable information available about the safety of non-viable, heat-killed L. rhamnosus formulations when used orally.
CHILDREN: LIKELY SAFE
when used orally and appropriately in children of most ages.
The strain Lacticaseibacillus rhamnosus GG has been used safely in studies lasting from five days to 36 months (4369,4372,4373,4377,7741,8565,8566,8567,8568,14334)(90280,96889,98427,98428,99782,107518,107539,107571,110988,112000)(112491,112492,112494,112502). L. rhamnosus LOCK 0900 has been used safely in combination with other probiotics for 3 months (107510). There is insufficient reliable information about the safety of non-viable, heat-killed L. rhamnosus formulations in children when taken orally. Also, there is insufficient reliable information available about the safety of L. rhamnosus in preterm infants with a birth weight under 1000 grams. Cases of bacteremia have occurred rarely in preterm infants given L. rhamnosus and other probiotics (102416,111610,111612,111613,111850,111852,111853). The US Food and Drug Administration (FDA) has issued a warning about cases of serious infections caused by probiotics reported in very preterm or very low birth weight infants under 1000 grams (111610). Similarly, the American Academy of Pediatrics does not support the routine administration of probiotics to these infants due to conflicting data on safety and efficacy (111608).
PREGNANCY: POSSIBLY SAFE
when used orally and appropriately.
Lacticaseibacillus rhamnosus GG has been used with apparent safety starting 2-4 weeks before delivery (7743,8515). L. rhamnosus HN001 has been used from 14-16 weeks' gestation until 6 months post-delivery (96888,98437). The combination of L. rhamnosus with Bifidobacterium longum has been used from 2 months prior to delivery until 2 months after delivery or throughout pregnancy (90285,105128,105144). The combination of L. rhamnosus GR-1 and Limosilactobacillus reuteri RC-14 has been used for up to two trimesters during pregnancy (102292,107562). A combination of L. rhamnosus, Lactobacillus jensenii, Lactobacillus crispatus, and Lactobacillus gasseri has been used safely for 3-4 weeks from 32-36 weeks' gestation (105131).
A meta-analysis of four clinical trials shows that taking probiotics during pregnancy increases the relative risk of pre-eclampsia by 85% when compared with placebo. Although the specific effects of L. rhamnosus are unclear from this analysis, two of the included studies used L. rhamnosus GG and one used L. rhamnosus HN001 (105185). More information is needed to determine if certain patients are at increased risk.
LACTATION: POSSIBLY SAFE
when used orally and appropriately.
Lacticaseibacillus rhamnosus GG has been used with apparent safety when breastfeeding for up to six months (7743,8515) and L. rhamnosus HN001 has been used from 14-16 weeks' gestation until 6 months post-delivery (96888,98437). A combination of L. rhamnosus and Bifidobacterium longum has been used with apparent safety from 2 months prior to delivery until 2 months after delivery (90285).
LIKELY SAFE ...when used orally in amounts commonly found in foods. Xylitol is an approved food additive in the US (17915).
POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts as a chewing gum, candy, lozenge, toothpaste, or mouth rinse. Xylitol has been used with apparent safety in doses of 20-53 grams daily for up to 3 years (6815,6819,6821). ...when used as nasal irrigation 1-3 times daily for up to 30 days (95115,95122,103889,105981). ...when inhaled via nebulizer. 5 mL of xylitol 15% solution has been used with apparent safety twice daily for up to 2 weeks (103888).
POSSIBLY UNSAFE ...when used orally in very high doses, long-term. There is some concern that very high doses for extended periods of use can induce tumor growth (6815,6820). However, this effect has not yet been demonstrated in humans.
CHILDREN: POSSIBLY SAFE
when used orally and appropriately in medicinal amounts as a chewing gum, candy, lozenge, toothpaste, or mouth rinse.
Xylitol has been used with apparent safety in doses up to 20 grams daily for up to three years (6815,6819).
PREGNANCY AND LACTATION:
There insufficient reliable information available about the use of xylitol in medicinal amounts during pregnancy and lactation; avoid using.
Below is general information about the interactions of the known ingredients contained in the product Digestive Daily Probiotic Chewables Fresh Orange Flavor. 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 Lacticaseibacillus rhamnosus with antibiotic drugs might decrease the effectiveness of L. rhamnosus.
 Details
L. rhamnosus preparations usually contain live and active organisms. Therefore, simultaneously taking antibiotics might kill a significant number of the organisms (1740). Tell patients to separate administration of antibiotics and L. rhamnosus preparations by at least two hours.
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Below is general information about the adverse effects of the known ingredients contained in the product Digestive Daily Probiotic Chewables Fresh Orange Flavor. 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, Lacticaseibacillus rhamnosus is generally well tolerated.
Most Common Adverse Effects:
Orally: Mild gastrointestinal adverse effects.
Serious Adverse Effects (Rare):
Orally: There is concern that L. rhamnosus may cause infections in some people.
Gastrointestinal
...Orally, taking Lacticaseibacillus rhamnosus alone or in combination with other probiotics may cause gastrointestinal side effects including diarrhea (90235); however, these events are uncommon.
In one small clinical study in infants with suspected cow's milk allergy who were receiving extensively hydrolyzed whey formula, diarrhea occurred in 5 of 13 infants receiving non-viable, heat-killed L. rhamnosus, compared with 0 of 14 infants receiving live L. rhamnosus and 0 of 8 infants receiving placebo (107528).
A 31-year-old male developed severe L. rhamnosus GG stomatitis and oral ulcers while undergoing induction chemotherapy for acute myeloid leukemia. The strain in the ulcers was determined to be the same strain that had been consumed in dairy products (112506).
Immunologic
...Since Lacticaseibacillus rhamnosus preparations contain live and active microorganisms, there is some concern that they might cause pathological infection in some patients.
Some lactobacilli species have been isolated in some cases of bacteremia, sepsis, splenic abscess, endocarditis, necrotizing fasciitis, pancreatic necrosis, and meningoencephalitis. Most of these cases are thought to be due to the translocation of bacteria from other locations in the body in which they occur naturally, such as the oral cavity and gastrointestinal system, in ill and/or immunocompromised patients, or in patients otherwise at risk of infection. However, there are also rare case reports of pathological infections possibly to intake of L. rhamnosus products in these populations (4380,4390,4391,4398,8561,13008,13070,90298,103444,105138)(105139,105141,107543,111613,112499,112505,112509,112536).
Case reports exist of bacteremia or sepsis associated with L. rhamnosus use in infants and children. In infants, some cases have occurred following the use of L. rhamnosus for the treatment or prevention of diarrhea. These cases include a severely ill 6-week-old infant given L. rhamnosus GG (Culturelle) for antibiotic-associated diarrhea (13008), a 6-day old with intrauterine growth restriction given L. rhamnosus GG to prevent antibiotic-associated diarrhea (112509), a 3-month-old infant given L. rhamnosus GG for the prevention of antibiotic-associated diarrhea, and a 18-day-old preterm, very-low-birthweight infant given L. rhamnosus GG for the prevention of necrotizing enterocolitis (111613). In other cases, infants with short bowel syndrome have developed bacteremia (13008,112536). One case report involved an 11-month-old infant receiving L. rhamnosus for 5 weeks through a gastrostomy tube for rotaviral diarrhea (13070). Lactobacillus sepsis has also occurred in a 6-year-old child with cerebral palsy following use of L. rhamnosus GG (Culturelle) for intermittent diarrhea (13008). A 17-year-old male with ulcerative colitis developed bacteremia following once daily use of L. rhamnosus GG 1 billion colony-forming units (CFUs) (Culturelle, ConAgra Foods) (90298).
There are also cases of L. rhamnosus bacteremia or sepsis in adults. Fatal L. rhamnosus septicemia has been reported in an immunocompromised patient consuming yogurt and taking prolonged courses of multiple broad spectrum antibiotics (8561). A 50-year-old male developed L. rhamnosus endocarditis following daily use of a probiotic product providing at least 5 billion CFUs of L. rhamnosus. Although the patient was considered healthy, the role of a previous diagnosis of an unspecified heart murmur or an untreated deep gingival cut 3 months prior to endocarditis diagnosis may have increased the risk of infection (105139). A 56-year-old immunocompetent female developed L. rhamnosus GG bacteremia. She was hospitalized with an indwelling catheter following a motor vehicle accident and had been given this strain following the onset of diarrhea via a nasogastric tube as per hospital protocol (112499). There is also a case of L. rhamnosus sepsis in a male in his late 60s with a bioprosthetic aortic valve. He was taking L. rhamnosus for ulcerative colitis and developed sepsis along with aortic valve endocarditis and septic emboli to the brain (112505).
A specific probiotic preparation (NBL probiotic ATP, Nobel) containing L. rhamnosus, Lacticaseibacillus casei, Lactiplantibacillus plantarum, Bifidobacterium animalis subsp. lactis, fructo-oligosaccharides, galacto-oligosaccharides, colostrum, and lactoferrin was found to be a significant risk factor for vancomycin-resistant Enterococcus colonization in premature infants. Although there was no direct link to determine causation, it was hypothesized that the probiotic mixture helped to mediate the acquisition and transfer of antibiotic resistance genes (96890).
General
...Orally, xylitol is generally well tolerated in food amounts, although it may cause gastrointestinal discomfort at high doses.
Topically, xylitol seems to be well tolerated.
Most Common Adverse Effects:
Orally: With high doses (30-40 grams), bowel sounds, diarrhea, flatulence.
Topically: Stinging of mucous membranes.
Endocrine ...Orally, high doses of xylitol can increase the risk of hyperuricemia. In a small study in healthy adults, taking a single dose of xylitol 35 grams in water increases levels of uric acid, while lower doses of xylitol did not have this effect (105980). Intravenous infusion of high doses of xylitol has been associated with hyperuricemia and acidosis, including lactic acidosis (6815).
Gastrointestinal ...Orally, acute administration of large amounts of xylitol (30 to 40 grams) can cause osmotic diarrhea, nausea, and flatulence (9,112857). However, if the dose is increased gradually, tolerance to this effect can occur and prevent development of diarrhea and flatulence (9).
Hepatic ...Intravenous infusion of high doses has been associated with changes in liver function enzymes (6815).
Immunologic ...There are various cases of suspected allergic reactions to xylitol. In one case, an anaphylactic reaction to xylitol was reported in a 2-year-old. The allergy was confirmed based on a skin-prick test and basophil activation test (100173).
Pulmonary/Respiratory ...Following use of xylitol in nasal irrigation, minor stinging in the nose has been reported (95122,105981).
