SPL v4
SPL
SPL Set ID 937b6700-3ba8-0266-e053-2995a90a3318
Route
SUBLINGUAL
Published
Effective Date 2019-09-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Passiflora Incarnata Flowering Top (12.07 g) Arabica Coffee Bean (14.94 g) Magnesium (3 [hp_X]) Strychnos Ignatii Seed (10 [hp_X]) Ipomoea Purga Root (8 [hp_X]) Palladium (14 [hp_X]) Tellurium Phosphoric Acid
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2015-02-09

Description

Active ingredients Each drop contains: Coffea cruda (Coffee) Unroasted Seed 10X Ignatia amara (St. Ignatius’ bean) Seed 8X Jalapa (Jalap) Tuber 8X Magnesium metallicum (Magnesium) 10X Passiflora incarnata (Passion flower) Aerial Parts 3X Phosphoricum acidum (Phosphoric acid) 14X Palladium metallicum (Palladium) 10X Tellurium metallicum (Tellurium) 10X


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

For the temporary relief of symptoms associated with irregular sleep patterns and ordinary restlessness.

Product ‘Uses’ are based on Homeopathic Materia Medica and are not supported by clinical trials. These 'Uses' have not been evaluated by the Food and Drug Administration.

Directions

To be taken 10 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 6 times daily depending on the severity of symptoms.

Adults and adolescents (12 years and older) Take 10 drops 3 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 10 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 6 times daily depending on the severity of symptoms.

Adults and adolescents (12 years and older) Take 10 drops 3 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: Coffea cruda (Coffee) Unroasted Seed 10X Ignatia amara (St. Ignatius’ bean) Seed 8X Jalapa (Jalap) Tuber 8X Magnesium metallicum (Magnesium) 10X Passiflora incarnata (Passion flower) Aerial Parts 3X Phosphoricum acidum (Phosphoric acid) 14X Palladium metallicum (Palladium) 10X Tellurium metallicum (Tellurium) 10X

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

Section 50566-9

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

Section 51727-6

Inactive ingredients

Ethanol (beet), purified water

Section 51945-4

NDC 62106-1322-0

UNDA

PLEX

PASSIFLORA PLEX

Homeopathic Preparation

For the temporary relief of symptoms associated with irregular sleep patterns and ordinary restlessness.

Contains 60% Alcohol

30 mL (1 fl oz)

Section 53414-9

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

Section 55105-1

Uses

For the temporary relief of symptoms associated with irregular sleep patterns and ordinary restlessness.

Section 55106-9

Active ingredients

Each drop contains:

Coffea cruda (Coffee) Unroasted Seed 10X

Ignatia amara (St. Ignatius’ bean) Seed 8X

Jalapa (Jalap) Tuber 8X

Magnesium metallicum (Magnesium) 10X

Passiflora incarnata (Passion flower) Aerial Parts 3X

Phosphoricum acidum (Phosphoric acid) 14X

Palladium metallicum (Palladium) 10X

Tellurium metallicum (Tellurium) 10X

Section 60561-8

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.

Indications & Usage Section

Addition of:

"Product ‘Uses’ are based on Homeopathic Materia Medica and are not supported by clinical trials. These 'Uses' have not been evaluated by the Food and Drug Administration."


Structured Label Content

Indications and Usage (34067-9)



Uses

For the temporary relief of symptoms associated with irregular sleep patterns and ordinary restlessness.

Product ‘Uses’ are based on Homeopathic Materia Medica and are not supported by clinical trials. These 'Uses' have not been evaluated by the Food and Drug Administration.

Directions

To be taken 10 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 6 times daily depending on the severity of symptoms.

Adults and adolescents (12 years and older) Take 10 drops 3 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 10 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 6 times daily depending on the severity of symptoms.

Adults and adolescents (12 years and older) Take 10 drops 3 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 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. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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

Section 51727-6 (51727-6)

Inactive ingredients

Ethanol (beet), purified water

Section 51945-4 (51945-4)

NDC 62106-1322-0

UNDA

PLEX

PASSIFLORA PLEX

Homeopathic Preparation

For the temporary relief of symptoms associated with irregular sleep patterns and ordinary restlessness.

Contains 60% Alcohol

30 mL (1 fl oz)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Uses

For the temporary relief of symptoms associated with irregular sleep patterns and ordinary restlessness.

Section 55106-9 (55106-9)

Active ingredients

Each drop contains:

Coffea cruda (Coffee) Unroasted Seed 10X

Ignatia amara (St. Ignatius’ bean) Seed 8X

Jalapa (Jalap) Tuber 8X

Magnesium metallicum (Magnesium) 10X

Passiflora incarnata (Passion flower) Aerial Parts 3X

Phosphoricum acidum (Phosphoric acid) 14X

Palladium metallicum (Palladium) 10X

Tellurium metallicum (Tellurium) 10X

Section 60561-8 (60561-8)

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.

Indications & Usage Section (Indications & Usage section)

Addition of:

"Product ‘Uses’ are based on Homeopathic Materia Medica and are not supported by clinical trials. These 'Uses' have not been evaluated by the Food and Drug Administration."


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)