The following Structured Product Label (SPL) was submitted to the FDA by Seroyal Usa for the product Paeonia Plex (NDC 62106-1198). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, overdosage, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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
Uses
Assists with the temporary relief of hemorrhoids.
Helps promote and maintain healthy liver function.
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 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.
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 ingredients
Ethanol (beet), purified water
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.
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.
Ndc (185180 30u Box)
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)
* Please review the disclaimer below.
