The following Structured Product Label (SPL) was submitted to the FDA by Seroyal Usa for the product Chelidonium Plex (NDC 62106-1201). 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 - pregnancy or breast feeding, otc - keep out of reach of children, overdosage, inactive ingredient, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients
Each drop contains:
Berberis vulgaris (Barberry) Bark 10X
Carduus marianus (Milk thistle) Fruit 3X
Chelidonium majus (Greater celandine) Rhizome and Root 10X
Dolichos pruriens (Cowhage) Dried Fruit Hairs 10X
Iris versicolor (Blue flag) Underground Parts 10X
Ptelea trifoliata (Hop tree) Leaf and Twig Bark 10X
Solidago virgaurea (Goldenrod) Inflorescences 3X
Taraxacum officinale (Common dandelion) Whole Plant 10X
Uses
Helps promote and maintain healthy liver and kidney functions and alleviates
symptoms associated with overindulgence of food and alcohol.
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.
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.
Inactive Ingredients:
Ethanol (beet),
purified water
Directions:
To be taken ten minutes away from food.
Children: Divided dosage by half and follow adult directions.
Invert bottle and shake lightly allowing for drops to fall directly under the tongue or into 1/4 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.
Uses
Helps promote and maintain healthy liver and kidney functions and alleviates symptoms associated with overindulgence
of food and alcohol.
Directions:
To be taken ten minutes away from food.
Invert bottle and shake lightly allowing for drops to fall directly under the tongue or into 1/4 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.
Other information
Do not use if seal is missing or broken.
Store in a cool, dry place.
NDC 62106-1201-0
UNDA
plex
CHELIDONIUM PLEX
Homeopathic Preparation
For the temporary relief of symptoms of food and alcohol overindulgence
Contains 25% Alcohol
1 fl oz (30 mL)
* Please review the disclaimer below.
