PAEONIA PLEX- aesculus hippocastanum,arnica montana, graphites, hamamelis virginiana, nitricum acidum, nux vomica, paeonia officinalis, sulphur liquid

PAEONIA Plex by

Drug Labeling and Warnings

PAEONIA Plex by is a Homeopathic medication manufactured, distributed, or labeled by Seroyal USA, SAN'UP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

Uses

Assists with the temporary relief of hemorrhoids.
Helps promote and maintain healthy liver function.

WARNINGS

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.

STOP USE

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

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OVERDOSAGE

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

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT

Inactive ingredients

Ethanol (beet), purified water

DOSAGE & 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.

INDICATIONS & 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.

PRINCIPAL DISPLAY PANEL

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)

INGREDIENTS AND APPEARANCE

PAEONIA PLEX 
aesculus hippocastanum,arnica montana, graphites, hamamelis virginiana, nitricum acidum, nux vomica, paeonia officinalis, sulphur liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62106-1198
Route of Administration	SUBLINGUAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327)	ARNICA MONTANA ROOT	4 [hp_C]  in 30 mL
GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O)	GRAPHITE	4 [hp_C]  in 30 mL
HAMAMELIS VIRGINIANA BARK (UNII: IH3063S9MY) (HAMAMELIS VIRGINIANA BARK - UNII:IH3063S9MY)	HAMAMELIS VIRGINIANA BARK	4 [hp_X]  in 30 mL
PAEONIA OFFICINALIS ROOT (UNII: 8R564U2E1P) (PAEONIA OFFICINALIS ROOT - UNII:8R564U2E1P)	PAEONIA OFFICINALIS ROOT	4 [hp_X]  in 30 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	6 [hp_X]  in 30 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	4 [hp_C]  in 30 mL
NITRIC ACID (UNII: 411VRN1TV4) (NITRIC ACID - UNII:411VRN1TV4)	NITRIC ACID	4 [hp_C]  in 30 mL
HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ)	HORSE CHESTNUT	3 [hp_X]  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62106-1198-0	1 in 1 CARTON	10/20/2015
1		30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/20/2015

Labeler - Seroyal USA (018361118)

Establishment
Name	Address	ID/FEI	Business Operations
SAN'UP		401010287	manufacture(62106-1198)