Label: CARDUUS PLEX- belladonna, carduus marianus, chelidonium majus, cholesterinum, cinchona succirubra, colocynthis, leptandra virginica, lycopodium clavatum, podophyllum peltatum, taraxacum officinale liquid
- NDC Code(s): 62106-1200-0
- 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 14, 2021
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active ingredients
Each drop contains:
Belladonna (Deadly nightshade) Whole Plant 4X (<1 x 10-6 % alkaloids, calculated)
Carduus marianus (Milk thistle) Fruit 2X
Chelidonium majus (Greater celandine) Rhizome and Root 2X
Cholesterinum (Cholesterol) 4X
Cinchona succirubra (Peruvian bark) Bark 3X
Colocynthis (Bitter apple) Fruit 6X
Leptandra virginica (Culver’s root) Underground Parts
Lycopodium clavatum (Clubmoss) Spores 4X
Podophyllum peltatum (Mayapple) Underground Parts 4X
Taraxacum officinale (Common dandelion)Whole Plant 2X - PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
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DOSAGE & ADMINISTRATION
Directions
To be taken ten minutes away from food.
Invert bottle and shake lightly allowing drops to fall directly under the tongue or into ¼ oz of water.
Hold contents for about 20 seconds and swallow.
To promote drop flow, invert bottle and shake before each use.Adults and adolescents (12 years and older)
Take 10 drops three times daily or as recommended by your healthcare practitioner.
Children (under 12 years)
Take under the direction of your healthcare practitioner.
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INDICATIONS & USAGE
Uses
Helps promote and maintain overall digestive health.
For the temporary relief of symptoms associated with poor digestion.Directions
To be taken ten minutes away from food.
Invert bottle and shake lightly allowing drops to fall directly under the tongue or into ¼ oz of water.Hold contents for about 20 seconds and swallow.
To promote drop flow, invert bottle and shake before each use.Adults and adolescents (12 years and older)
Take 10 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
CARDUUS PLEX
belladonna, carduus marianus, chelidonium majus, cholesterinum, cinchona succirubra, colocynthis, leptandra virginica, lycopodium clavatum, podophyllum peltatum, taraxacum officinale liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62106-1200 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MILK THISTLE (UNII: U946SH95EE) (MILK THISTLE - UNII:U946SH95EE) MILK THISTLE 2 [hp_X] in 30 mL CHOLESTEROL (UNII: 97C5T2UQ7J) (CHOLESTEROL - UNII:97C5T2UQ7J) CHOLESTEROL 4 [hp_X] in 30 mL LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 4 [hp_X] in 30 mL PODOPHYLLUM PELTATUM ROOT (UNII: 2S713A4VP3) (PODOPHYLLUM - UNII:2S713A4VP3) PODOPHYLLUM PELTATUM ROOT 4 [hp_X] in 30 mL TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE 2 [hp_X] in 30 mL CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS 2 [hp_X] in 30 mL CULVER'S ROOT (UNII: M2O62YTN42) (CULVER'S ROOT - UNII:M2O62YTN42) CULVER'S ROOT 1 [hp_X] in 30 mL CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP 6 [hp_X] in 30 mL CINCHONA PUBESCENS BARK (UNII: S96N10R972) (CINCHONA PUBESCENS BARK - UNII:S96N10R972) CINCHONA PUBESCENS BARK 3 [hp_X] in 30 mL ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 4 [hp_X] in 30 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62106-1200-0 1 in 1 CARTON 05/18/2016 1 30 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 05/18/2016 Labeler - Seroyal USA (018361118) Establishment Name Address ID/FEI Business Operations SAN'UP 401010287 manufacture(62106-1200)
