Lobelia Plex

Lobelia Plex
SPL v4
SPL
SPL Set ID 270e4074-0309-2573-e054-00144ff88e88
Route
ORAL
Published
Effective Date 2018-07-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Blatta Orientalis (6 [hp_X]) Antimony Pentasulfide (8 [hp_X]) Arsenic Cation (3+) (3 [hp_X]) Eriodictyon Californicum Leaf (4 [hp_X]) Ipecac (10 [hp_X]) Lobelia Inflata (1 [hp_X]) Sodium Sulfate Anhydrous Sambucus Nigra Flowering Top Polygala Senega Root
Inactive Ingredients
Glycerin Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2015-12-16

Description

Active ingredients Each drop contains: Antimonium sulphuratum aureum (Golden antimony sulfide) 8X Arsenicum iodatum (Arsenic triiodide) 8X Blatta orientalis (Indian cockroach) Live Insect 6X Eriodictyon californicum (Yerba santa) Aerial Parts 3X Ipecacuanha (Ipecac) Underground Parts 4X Lobelia inflata (Indian tobacco) Whole Plant 8X Natrum sulphuricum (Sodium sulfate) 10X Sambucus nigra (European elder) Leaves and Inflorescences 1X Senega officinalis (Seneca snakeroot) Root 1X


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.

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: Antimonium sulphuratum aureum (Golden antimony sulfide) 8X Arsenicum iodatum (Arsenic triiodide) 8X Blatta orientalis (Indian cockroach) Live Insect 6X Eriodictyon californicum (Yerba santa) Aerial Parts 3X Ipecacuanha (Ipecac) Underground Parts 4X Lobelia inflata (Indian tobacco) Whole Plant 8X Natrum sulphuricum (Sodium sulfate) 10X Sambucus nigra (European elder) Leaves and Inflorescences 1X Senega officinalis (Seneca snakeroot) Root 1X

Section 34088-5

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

Section 50565-1

Keep out of reach of children.

Section 50566-9

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.

Section 50569-3

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.

Section 51727-6

Inactive ingredients

Ethanol (beet), glycerin, purified water

Section 51945-4

NDC 62106-1195-0

UNDA

plex

LOBELIA PLEX

Homeopathic Preparation

Assists with the temporary relief of cough.

Contains 76% 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:

Antimonium sulphuratum aureum (Golden antimony sulfide) 8X

Arsenicum iodatum (Arsenic triiodide) 8X

Blatta orientalis (Indian cockroach) Live Insect 6X

Eriodictyon californicum (Yerba santa) Aerial Parts 3X

Ipecacuanha (Ipecac) Underground Parts 4X

Lobelia inflata (Indian tobacco) Whole Plant 8X

Natrum sulphuricum (Sodium sulfate) 10X

Sambucus nigra (European elder) Leaves and Inflorescences 1X

Senega officinalis (Seneca snakeroot) Root 1X

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.

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

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 34088-5 (34088-5)

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.

Section 50566-9 (50566-9)

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.

Section 50569-3 (50569-3)

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.

Section 51727-6 (51727-6)

Inactive ingredients

Ethanol (beet), glycerin, purified water

Section 51945-4 (51945-4)

NDC 62106-1195-0

UNDA

plex

LOBELIA PLEX

Homeopathic Preparation

Assists with the temporary relief of cough.

Contains 76% 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:

Antimonium sulphuratum aureum (Golden antimony sulfide) 8X

Arsenicum iodatum (Arsenic triiodide) 8X

Blatta orientalis (Indian cockroach) Live Insect 6X

Eriodictyon californicum (Yerba santa) Aerial Parts 3X

Ipecacuanha (Ipecac) Underground Parts 4X

Lobelia inflata (Indian tobacco) Whole Plant 8X

Natrum sulphuricum (Sodium sulfate) 10X

Sambucus nigra (European elder) Leaves and Inflorescences 1X

Senega officinalis (Seneca snakeroot) Root 1X

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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