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Natural Product Number (NPN):

80109774

Market status:

Marketed

Licence Status:

Active

Brand name(s):

New Roots Essence

Licence holder:

New Roots Herbal Inc.

Dosage Form:

Tincture

Recommended route of administration:

Oral

Recommended use or purpose:

Burdock is traditionally used in Herbal Medicine as a diuretic, diaphoretic and alterative to help remove accumulated waste products via the kidneys, skin and mucus membranes.

Risk Information:

Cautions and Warnings 

Consult a health care practitioner prior to use if you have a medical condition or if you are taking any medications. Keep out of reach of children. Discontinue use if abdominal pain, diarrhea or vomiting occurs. Mild headaches, nausea, and flu like symptoms may occur. In such cases, reduce initial dose to one tablespoon daily for the first week and gradually increase to the suggested adult dosage thereafter. Consult a health care practitioner if symptoms persist or worsen. This product contains 25% of ethanol (alcohol), i.e. up to 11.8g per dose, which is equivalent to about 1.5 glasses of wine, per 4 tablespoons. Consult with a health care practitioner prior to use if you have an alcohol related disease, liver disease, epilepsy, diabetes or hypertension. Consult a health care practitioner prior to use if you are taking any other medications, as the amount of ethanol in this product may alter their effects. The amount of alcohol in this product may impair your ability to drive or use machines.

Contra-Indications 

Do not use if you are pregnant or breastfeeding, allergic to plants of the Asteraceae/Compositae/Daisy/Polygonaceae/Brassicacease family, taking products containing diuretics, have heart disease, high blood or low blood pressure, kidney or liver disorder, diabetes or edema (swelling of the hands, face and feet). Do not exceed the recommended dose unless suggested by a health care practitioner.

Known Adverse Reactions 

Hypersensitivity/allergy is known to occur; in which case, discontinue use. Stop use and seek medical attention immediately if you experience dizziness, confusion, muscle weakness or pain, abnormal heart beat and/or difficulty breathing.

List of medicinal ingredients:

Medicinal ingredients	Quantity (Qty)	Extract	Potency
Arctium lappa	7.6173 mL	1 : 44.287 DHE: 172 mg Dry
Cnicus benedictus	0.354296 mL	1 : 44.287 DHE: 8 mg Dry
Handroanthus heptaphyllus	1.35961 mL	1 : 44.287 DHE: 30.7 mg Dry
Nasturtium officinale	0.354296 mL	1 : 44.287 DHE: 8 mg Dry
Rheum officinale	0.221435 mL	1 : 44.287 DHE: 5 mg Dry
Rumex acetosella	3.80868 mL	1 : 44.287 DHE: 86 mg Dry
Trifolium pratense	0.354296 mL	1 : 44.287 DHE: 8 mg Dry
Ulmus rubra	0.930027 mL	1 : 44.287 DHE: 21 mg Dry

List of non-medicinal ingredients:

• Ascophyllum nodosum Powder
• Grain alcohol
• Purified water

Date of licensing:

2021-05-07

Revised date of licence:

2021-05-19