Paeonia Plex

Paeonia Plex
SPL v5
SPL
SPL Set ID 228f83c4-269c-49b3-e054-00144ff8d46c
Route
SUBLINGUAL
Published
Effective Date 2015-10-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana Root (4 [hp_C]) Graphite (4 [hp_X]) Hamamelis Virginiana Bark (6 [hp_X]) Paeonia Officinalis Root (3 [hp_X]) Sulfur Strychnos Nux-vomica Seed Nitric Acid Horse Chestnut
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2015-10-20

Description

Active ingredients Each drop contains: Aesculus hippocastanum (Horse chestnut) Seeds 3X Arnica montana (Leopard's bane) Underground Parts 4CH Graphites (Black lead) 4CH Hamamelis virginiana (Witch hazel) Bark 4X Nitricum acidum (Nitric acid) 4CH Nux vomica (Poison nut) Seeds 4CH (<2.7 x 10-9 % alkaloids, calculated) Paeonia officinalis (Peony) Underground Parts 4X Sulphur (Sublimed sulfur) 6X


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

Assists with the temporary relief of hemorrhoids.

Helps promote and maintain healthy liver function.

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: Aesculus hippocastanum (Horse chestnut) Seeds 3X Arnica montana (Leopard's bane) Underground Parts 4CH Graphites (Black lead) 4CH Hamamelis virginiana (Witch hazel) Bark 4X Nitricum acidum (Nitric acid) 4CH Nux vomica (Poison nut) Seeds 4CH (<2.7 x 10-9 % alkaloids, calculated) Paeonia officinalis (Peony) Underground Parts 4X Sulphur (Sublimed sulfur) 6X

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 symptoms persist or worsen.

Section 51727-6

Inactive ingredients

Ethanol (beet), purified water

Section 51945-4

NDC 62106-1198-0

UNDA

Plex

PAEONIA PLEX

Homeopathic Preparation

Assists with the temporary relief of

hemorrhoids and helps promote and

maintain healthy liver function.

Contains 25% 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 hemorrhoids.

Helps promote and maintain healthy liver function.

Section 55106-9

Active ingredients

Each drop contains:

Aesculus hippocastanum (Horse chestnut) Seeds 3X

Arnica montana (Leopard's bane) Underground Parts 4CH

Graphites (Black lead) 4CH

Hamamelis virginiana (Witch hazel) Bark 4X

Nitricum acidum (Nitric acid) 4CH

Nux vomica (Poison nut) Seeds 4CH (<2.7 x 10-9 % alkaloids, calculated)

Paeonia officinalis (Peony) Underground Parts 4X

Sulphur (Sublimed sulfur) 6X

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 hemorrhoids.

Helps promote and maintain healthy liver function.

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

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.

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 62106-1198-0

UNDA

Plex

PAEONIA PLEX

Homeopathic Preparation

Assists with the temporary relief of

hemorrhoids and helps promote and

maintain healthy liver function.

Contains 25% 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 hemorrhoids.

Helps promote and maintain healthy liver function.

Section 55106-9 (55106-9)

Active ingredients

Each drop contains:

Aesculus hippocastanum (Horse chestnut) Seeds 3X

Arnica montana (Leopard's bane) Underground Parts 4CH

Graphites (Black lead) 4CH

Hamamelis virginiana (Witch hazel) Bark 4X

Nitricum acidum (Nitric acid) 4CH

Nux vomica (Poison nut) Seeds 4CH (<2.7 x 10-9 % alkaloids, calculated)

Paeonia officinalis (Peony) Underground Parts 4X

Sulphur (Sublimed sulfur) 6X

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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