Label: UNDA 44- inula helenium root, juniperus communis berry, uva-ursi leaf, dulcamara stem and leaf, cytisus scoparius aerial parts, stigmata maidis style and stigma, argentum metallicum, aurum metallicum liquid
- NDC Code(s): 62106-1143-8
- Packager: Seroyal USA
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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 July 7, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active ingredients
Each drop contains:
Argentum metallicum (Silver) 12X
Aurum metallicum (Gold) 12X
Cytisus scoparius (Scotch broom) Aerial Parts 4X
Dulcamara (Bittersweet) Shoots 4X
Inula helenium (Elecampane) Root 4X
Juniperus communis (Common juniper) Berry 4X
Stigmata maidis (Maize) Style and Stigma 4X
Uva-ursi (Bearberry) Leaf 4X - PURPOSE
- WARNINGS
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- ASK DOCTOR
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
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INDICATIONS & USAGE
Uses
For the temporary relief of symptoms associated with minor urinary discomfort.Directions:
Adults and adolescents (12 years and older)
Take 5 drops three times daily or as recommended by your healthcare practitioner.
Children (under 12 years)
Take under the direction of your healthcare practitioner.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
UNDA 44
inula helenium root, juniperus communis berry, uva-ursi leaf, dulcamara stem and leaf, cytisus scoparius aerial parts, stigmata maidis style and stigma, argentum metallicum, aurum metallicum liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62106-1143 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GOLD (UNII: 79Y1949PYO) (GOLD - UNII:79Y1949PYO) GOLD 12 [hp_X] in 20 mL SILVER (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G) SILVER 12 [hp_X] in 20 mL JUNIPER BERRY (UNII: O84B5194RL) (JUNIPER BERRY - UNII:O84B5194RL) JUNIPER BERRY 4 [hp_X] in 20 mL ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36) (ARCTOSTAPHYLOS UVA-URSI LEAF - UNII:3M5V3D1X36) ARCTOSTAPHYLOS UVA-URSI LEAF 4 [hp_X] in 20 mL SOLANUM DULCAMARA STEM (UNII: IR986LE7DF) (SOLANUM DULCAMARA STEM - UNII:IR986LE7DF) SOLANUM DULCAMARA STEM 4 [hp_X] in 20 mL CYTISUS SCOPARIUS FLOWERING TOP (UNII: XZC6H8R666) (CYTISUS SCOPARIUS FLOWERING TOP - UNII:XZC6H8R666) CYTISUS SCOPARIUS FLOWERING TOP 4 [hp_X] in 20 mL CORN SILK (UNII: 7D3VB244UX) (CORN SILK - UNII:7D3VB244UX) CORN SILK 4 [hp_X] in 20 mL INULA HELENIUM ROOT (UNII: E55SMD6DA8) (INULA HELENIUM ROOT - UNII:E55SMD6DA8) INULA HELENIUM ROOT 4 [hp_X] in 20 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62106-1143-8 1 in 1 BOX 12/17/2014 1 20 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/17/2014 Labeler - Seroyal USA (018361118) Establishment Name Address ID/FEI Business Operations SAN’UP 401010287 manufacture(62106-1143)
