Carduus Plex

Carduus Plex
SPL v3
SPL
SPL Set ID 330fa208-69c2-6c37-e054-00144ff88e88
Route
ORAL
Published
Effective Date 2016-05-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Milk Thistle (2 [hp_X]) Cholesterol (4 [hp_X]) Lycopodium Clavatum Spore (1 [hp_X]) Podophyllum (6 [hp_X]) Taraxacum Officinale (3 [hp_X]) Chelidonium Majus Culver's Root Citrullus Colocynthis Fruit Pulp Cinchona Pubescens Bark Atropa Belladonna
Inactive Ingredients
Alcohol Water Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2016-05-18

Description

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


Medication Information

Warnings and Precautions

Warnings

Stop use and ask a doctor if symptoms persist or worsen.

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Indications and 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.

Dosage and 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.

Description

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

Section 50565-1

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 51727-6

Inactive ingredients

Ethanol (beet), glycerin, purified water

Section 51945-4

NDC 62106-1200-0

UNDA

plex

CARDUUS PLEX

Homeopathic Preparation

For the temporary relief of symptoms associated with poor digestion.

Contains 45% Alcohol

1 fl oz (30 mL)

Section 53414-9

If pregnant or breastfeeding, ask a health professional before use.

Section 55105-1

Uses

Helps promote and maintain overall digestive health.

For the temporary relief of symptoms associated with poor digestion.

Section 55106-9

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

Section 60561-8

Other information

  • Do not use if seal is missing or broken.
  • Store in a cool, dry place.
  • Contents may not fill package in order to accommodate required labeling.Please rely on stated quantity.

Structured Label Content

Indications and Usage (34067-9)

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.

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

Warnings

Stop use and ask a doctor if symptoms persist or worsen.

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive ingredients

Ethanol (beet), glycerin, purified water

Section 51945-4 (51945-4)

NDC 62106-1200-0

UNDA

plex

CARDUUS PLEX

Homeopathic Preparation

For the temporary relief of symptoms associated with poor digestion.

Contains 45% Alcohol

1 fl oz (30 mL)

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health professional before use.

Section 55105-1 (55105-1)

Uses

Helps promote and maintain overall digestive health.

For the temporary relief of symptoms associated with poor digestion.

Section 55106-9 (55106-9)

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

Section 60561-8 (60561-8)

Other information

  • Do not use if seal is missing or broken.
  • Store in a cool, dry place.
  • Contents may not fill package in order to accommodate required labeling.Please rely on stated quantity.

Advanced Ingredient Data


Raw Label Data

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