Drosera Plex

Drosera Plex
SPL v4
SPL
SPL Set ID 43a4b756-c80d-5043-e054-00144ff8d46c
Route
SUBLINGUAL
Published
Effective Date 2018-07-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Copper (6 [hp_X]) Artemisia Cina Flower (2 [hp_X]) Ferrum Phosphoricum Ipecac Solidago Virgaurea Flowering Top Drosera Rotundifolia Flowering Top Atropa Belladonna Whole Arnica Montana Root Protortonia Cacti Corallium Rubrum Exoskeleton
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2016-12-14

Description

Active ingredients Each drop contains: Arnica montana (Leopard's bane) Underground Parts 6X Belladonna (Deadly nightshade) Whole Plant 6X (<1 x 10-8 % alkaloids, calculated) Cina (Wormseed) Flower-heads 6X Coccus cacti (Cochineal) 6X Corallium rubrum (Red coral) Calcareous Exoskeleton 6X Cuprum metallicum (Copper) 6X Drosera (Sundew) Whole Plant 6X Ferrum phosphoricum (Hydrated iron (III) phosphate) 6X Ipecacuanha (Ipecac) Underground Parts 6X Solidago virgaurea (Goldenrod) Inflorescences 2X


Medication Information

Warnings and Precautions

Warnings

Ask a doctor before use if you have

Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

Cough that is accompanied by excessive phlegm (mucus) or fever.

Stop use and ask a doctor if

Cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

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

Assists with the temporary relief of cough.

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.

Dosage frequency may be increased up to six times daily depending on the severity of symptoms.

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.

Dosage frequency may be increased up to six times daily depending on the severity of symptoms.

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: Arnica montana (Leopard's bane) Underground Parts 6X Belladonna (Deadly nightshade) Whole Plant 6X (<1 x 10-8 % alkaloids, calculated) Cina (Wormseed) Flower-heads 6X Coccus cacti (Cochineal) 6X Corallium rubrum (Red coral) Calcareous Exoskeleton 6X Cuprum metallicum (Copper) 6X Drosera (Sundew) Whole Plant 6X Ferrum phosphoricum (Hydrated iron (III) phosphate) 6X Ipecacuanha (Ipecac) Underground Parts 6X Solidago virgaurea (Goldenrod) Inflorescences 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), purified water

Section 51945-4

NDC 62106-1194-0

UNDA

plex

DROSERA PLEX

Homeopathic Preparation

Assists with the temporary relief of cough.

Contains 31% Alcohol

1 fl oz (30 mL)

Section 53414-9

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

Section 55105-1

Uses

Assists with the temporary relief of cough.

Section 55106-9

Active ingredients

Each drop contains:

Arnica montana (Leopard's bane) Underground Parts 6X

Belladonna (Deadly nightshade) Whole Plant 6X (<1 x 10-8 % alkaloids, calculated)

Cina (Wormseed) Flower-heads 6X

Coccus cacti (Cochineal) 6X

Corallium rubrum (Red coral) Calcareous Exoskeleton 6X

Cuprum metallicum (Copper) 6X

Drosera (Sundew) Whole Plant 6X

Ferrum phosphoricum (Hydrated iron (III) phosphate) 6X

Ipecacuanha (Ipecac) Underground Parts 6X

Solidago virgaurea (Goldenrod) Inflorescences 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

Assists with the temporary relief of cough.

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.

Dosage frequency may be increased up to six times daily depending on the severity of symptoms.

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.

Dosage frequency may be increased up to six times daily depending on the severity of symptoms.

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

Ask a doctor before use if you have

Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

Cough that is accompanied by excessive phlegm (mucus) or fever.

Stop use and ask a doctor if

Cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

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), purified water

Section 51945-4 (51945-4)

NDC 62106-1194-0

UNDA

plex

DROSERA PLEX

Homeopathic Preparation

Assists with the temporary relief of cough.

Contains 31% 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

Assists with the temporary relief of cough.

Section 55106-9 (55106-9)

Active ingredients

Each drop contains:

Arnica montana (Leopard's bane) Underground Parts 6X

Belladonna (Deadly nightshade) Whole Plant 6X (<1 x 10-8 % alkaloids, calculated)

Cina (Wormseed) Flower-heads 6X

Coccus cacti (Cochineal) 6X

Corallium rubrum (Red coral) Calcareous Exoskeleton 6X

Cuprum metallicum (Copper) 6X

Drosera (Sundew) Whole Plant 6X

Ferrum phosphoricum (Hydrated iron (III) phosphate) 6X

Ipecacuanha (Ipecac) Underground Parts 6X

Solidago virgaurea (Goldenrod) Inflorescences 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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