Label: WATER- betula pendula, cortex, lappa major, plantago major, taraxacum officinale, capsule
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Contains inactivated NDC Code(s)
NDC Code(s): 57520-0595-1 - Packager: Apotheca Company
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated January 25, 2011
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- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
WATER X
betula pendula, cortex, lappa major, plantago major, taraxacum officinale, capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57520-0595 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETULA PENDULA BARK (UNII: 40S83Y133C) (BETULA PENDULA BARK - UNII:40S83Y133C) BETULA PENDULA BARK 4 [hp_X] in 1 g ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) (ARCTIUM LAPPA ROOT - UNII:597E9BI3Z3) ARCTIUM LAPPA ROOT 4 [hp_X] in 1 g PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR 4 [hp_X] in 1 g TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE 4 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) BETULA PUBESCENS LEAF (UNII: 84SOH0O3OO) ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) TARAXACUM OFFICINALE ROOT (UNII: 9DE5YCO0RU) AGATHOSMA BETULINA LEAF (UNII: 369DDH39Z0) ELYMUS REPENS ROOT (UNII: 3IXW0F6P8W) JUNIPERUS COMMUNIS FRUIT (UNII: O84B5194RL) POWDERED CELLULOSE (UNII: SMD1X3XO9M) Product Characteristics Color white (white) Score no score Shape CAPSULE (none) Size 25mm Flavor Imprint Code none Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57520-0595-1 30 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/25/2011 Labeler - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture