Two capsules contain: Amylase 6800 DU • Protease Protease Note: 250,000 HUT/G 19,600 HUT • Lipase 72 LU • Cellulase 80 CU. Other Ingredients: Plant Fiber , Gelatin , Water.
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 Formula 20. 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
Proteolytic enzymes represent a wide group of enzymes that are used alone or in combination. See specific monographs for effectiveness information.
Below is general information about the safety of the known ingredients contained in the product Formula 20. 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. Gelatin has Generally Recognized as Safe (GRAS) status in the US (4912).
POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts, short-term . A specific type of gelatin from donkey hide, called colla corii asini, has been safely used in doses of 6-10 grams orally daily for 6-8 weeks. Higher doses of 15 grams daily have been associated with an increased risk of inflammatory adverse effects, including sore throat, swollen gums, local eczema, and oral ulcers (97634,107011). Since gelatin is often derived from bovine bones and skin, there is some concern about contamination with diseased animal parts (1825). So far, there are no reports of disease transmission to humans due to use of contaminated gelatin preparations.
CHILDREN: POSSIBLY SAFE
when gelatin tannate is used orally and appropriately in medicinal amounts, short-term.
In children under 15 kg or under 3 years of age, gelatin tannate has been used with apparent safety at doses up to 250 mg four times daily for up to 5 days. In children over 15 kg or over 3 years of age, it has been used with apparent safety at doses up to 500 mg four times daily for up to 5 days (103296). There is insufficient reliable information available about the safety of other forms of gelatin in children.
PREGNANCY: LIKELY SAFE
when used orally in the amounts commonly found in foods.
PREGNANCY: POSSIBLY SAFE
when a specific type of gelatin from donkey hide, called colla corii asini, is used orally in doses of 10 grams daily for 6 weeks.
Higher doses of 15 grams daily have been associated with an increased risk of inflammatory adverse effects, including sore throat, swollen gums, local eczema, and ulcers in the oral cavity (97634).
There is insufficient reliable information available about the safety of other types of gelatin when used during pregnancy in medicinal amounts.
LACTATION: LIKELY SAFE
when used orally in the amounts commonly found in foods.
There is insufficient reliable information available about the safety of using larger amounts of gelatin during lactation; avoid using.
There is insufficient reliable information available about the safety of lipase.
CHILDREN: POSSIBLY UNSAFE
when recombinant human bile salt-stimulated lipase (rhBSSL) is used orally by premature infants.
Adding rhBSSL to infant formula or pasteurized breast milk increases the risk for serious gastrointestinal adverse effects in premature infants (101940).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
POSSIBLY SAFE ...when used orally and appropriately. Various proteolytic enzymes have been safely used orally in clinical research (716,964,965,968,969,6252,6253,10622,11457,18281,18284) (91104,91105,91106,91111,96449). Side effects are typically mild to moderate and most often include gastrointestinal effects. See specific monographs for more detailed information related to the safety of individual proteolytic enzymes. ...when used topically and appropriately. Various proteolytic enzymes have been safely used topically in clinical research (67835,67843,67845,91113). Some proteolytic enzymes might cause allergic reactions when used topically. See specific monographs for more detailed information related to the safety of individual proteolytic enzymes.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
Below is general information about the interactions of the known ingredients contained in the product Formula 20. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Below is general information about the adverse effects of the known ingredients contained in the product Formula 20. 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, gelatin seems to be well tolerated.
Most Common Adverse Effects:
Oral: Belching, bloating, and dyspepsia.
Serious Adverse Effects (Rare):
Injection: IgE-mediated allergic reactions, Kounis syndrome.
Gastrointestinal ...Orally, gelatin can cause unpleasant taste, sensation of heaviness in the stomach, bloating, dyspepsia, and belching (7704).
Immunologic
...Gelatin can cause allergic reactions.
Gelatin in foods can cause initial sensitization (7703). Gelatin-containing medicines including oral medications, suppositories, vaccines, and injectable products can cause IgE-mediated allergic reactions, including urticaria, angioedema, wheezing, hypotension, and anaphylaxis (7708,7709,7710,97633,111345). In the US, gelatin is used as a stabilizer in some vaccines such as measles, mumps, and rubella (MMR), and diphtheria, pertussis, tetanus (DPT) (7711). In one case report, a 73-year-old male experienced anaphylactic symptoms within 10 minutes of receiving gelatin lysate as a plasma expander during a routine surgery. The patient proceeded to develop heart, respiratory, and kidney failure and died 76 days after receiving the gelatin infusion (97633). At least 12 case reports describe life-threatening anaphylaxis after administration of gelatin-containing hemostatic agents during surgery. In these cases, hypotension, tachycardia, and increased airway pressure occurred shortly after injection of the agent into the pedicle tract (111345).
There are at least two cases of Kounis syndrome, an acute coronary syndrome related to a massive mast cell activation, after the use of a gelatin infusion during general anesthesia. In one case, immediate symptoms included bradycardia and hypotension, followed by myocardial ischemia and coronary vasospasm (97631).
Other ...Since gelatin is sometimes produced from bovine bones and skin, there is some concern about the potential risk of contamination with diseased animals and transmission of bovine spongiform encephalopathy (BSE, mad cow disease) and other diseases (1825). So far, there are no reports of BSE or other disease transmission to humans from gelatin products.
General
...No adverse effects have been reported in adults.
However, a thorough evaluation of safety outcomes has not been conducted.
Serious Adverse Effects (Rare):
Orally: Gastrointestinal adverse effects, such as necrotizing enterocolitis, when recombinant human bile salt-stimulated lipase is used in premature infants.
Gastrointestinal ...Orally, when added to the formula or pasteurized breast milk consumed by premature infants, recombinant human bile salt-stimulated lipase (rhBSSL) can cause gastrointestinal adverse effects, including abdominal distension, flatulence, constipation, colic, abdominal pain, gastroenteritis, vomiting, regurgitation, and rectal bleeding (101940). Premature infants receiving rhBSSL also had a slightly higher rate of necrotizing enterocolitis (NEC) when compared with those receiving placebo. After review by a panel of experts, it was determined that the rate of confirmed or suspected NEC in infants consuming rhBSSL was 3.3%, compared with 0.5% in those receiving placebo. Although this rate of NEC is lower than the historical rate of occurrence in premature infants (11%), a possible increased risk for NEC cannot be ruled out (101940).
General
...Orally, proteolytic enzymes are generally well tolerated.
See specific monographs for detailed safety information related to individual proteolytic enzymes.
Most Common Adverse Effects:
Orally: Gastrointestinal upset.
Serious Adverse Effects (Rare):
Topically: Allergic reactions.
Gastrointestinal ...Orally, some patients taking proteolytic enzymes may have gastrointestinal complaints (101517).
Immunologic ...Proteolytic enzymes are commonly found in laundry detergents and pre-spotter products. Rarely, protease specific IgE positive tests possibly related to these products have occurred. Exposure may be airborne or topical (102705). In addition, in case reports, occupational exposure to the airborne proteolytic enzyme pepsin has resulted in allergic rhinoconjunctivitis or asthma (102706,102707).
