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Natural Product Number (NPN):

80090702

Market status:

Marketed

Licence Status:

Active

Brand name(s):

Digestive Enzymes

Licence holder:

New Roots Herbal Inc.

Dosage Form:

Capsule

Recommended route of administration:

Oral

Recommended use or purpose:

Digestive aid to help decrease bloating after high caloric, high fat meals. Helps to decrease bloating after high caloric, high fat meals.

Digestive Enzymes.

Risk Information:

Cautions and Warnings 

If symptoms persist or worsen, consult a health care practitioner. If you have diabetes, consult a health care practitioner prior to use. If you have pancreatitis, pancreatic exocrine insufficiency or cystic fibrosis, consult a health care practitioner prior to use. If you have allergy to latex or fruits (such as avocado, banana, chestnut, passion fruit, fig, melon, mango, kiwi, pineapple, peach, and tomato), consult a health care practitioner prior to use. If you have a peptic ulcer or excess stomach acid, consult a health care practitioner prior to use. If you are taking an anticoagulant/ blood thinner or an anti-inflammatory, or are having surgery, consult a health care practitioner prior to use. Consult a health care practitioner prior to use if you are taking thiazide diurectics, corticosteroids, licorice root or other medications or health products which may aggravate electrolyte imbalance. Laxative effect may occur. Discontinue use if you experience abdominal pain, cramps, spasms and/or diarrhea. Consult a health care practition prior to use if you have faecal impaction or symptoms such as abdominal pain, nausea, vomiting or fever.

Contra-Indications 

Do not use if you suffer from gastric reflux or if you have gastrointestinal lesions/ulcers.If you are sensitive to pancreatic enzymes or pork enzymes, do not use this product. Do not use if you are pregnant or breastfeeding. Do not use if you have liver, gastrointestinal tract or gallbladder disorders and/or bowel obstruction. Do not use if you have gallstones or a bile duct obstruction. Do not use if you have abnormal constrictions of the gastrointestinal tract, potential or existing intestinal blockage, atonic bowel, appendicitis, inflammatory colon disease such as Crohn¿s disease or ulcerative colitis, abdominal pain of unknown origin, undiagnosed rectal bleeding, severe dehydration with depleted water or electrolytes or diarrhea.

Known Adverse Reactions 

Nausea, vomiting, abdominal pain/epigastric pain and/or heartburn have been known to occur, in which case discontinue use (and consult a health care practitioner). Hypersensitivity/allergy has been known to occur; in which case, discontinue use.

List of medicinal ingredients:

Medicinal ingredients	Quantity (Qty)	Extract	Potency
1-Carboxy-N,N,N-trimethylmethanaminium chloride	105.3 milligrams
Bos Taurus	64.8 milligrams		45.0   % Cholic Acids
Pancreatic Enzymes	200.0 milligrams		20000.0   USP Protease 1600.0   USP Lipase 20000.0   USP Amylase
Papain	3.84 milligrams		384000.0   FCC PU
Pepsin A	32.4 milligrams		324000.0   FCC pepsin unit

List of non-medicinal ingredients:

• Hypromellose
• Magnesium Stearate
• Microcrystalline cellulose
• Purified water
• Silicon dioxide

Date of licensing:

2019-02-19

Revised date of licence:

2022-02-11