The following Structured Product Label (SPL) was submitted to the FDA by Seroyal Usa for the product Unda 219 (NDC 62106-1156). 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 - keep out of reach of children, otc - pregnancy or breast feeding, other safety information, 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:
Crataegus (Hawthorn) Fruit 4X
Lactuca virosa (Poisonous lettuce) Whole Plant 4X
Passiflora incarnata (Passion flower) Aerial Parts 4X
Thymus vulgaris Aerial Parts 4X
Valeriana officinalis (Valerian) Root 4X
Uses
Helps to promote relaxation and temporarily relieve mild nervousness
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.
Keep out of reach of children.
If pregnant or breastfeeding, ask a health professional before use.
Other information
Do not use if seal is missing or broken.
Store in a cool, dry place.
Inactive ingredients
Ethanol (beet), purified water
Directions
Adults and adolescents (12 years and older)
Take 5 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 to promote relaxation and temporarily relieve mild nervousness
Directions
Adults and adolescents (12 years and older): Take 5 drops three times daily or as
recommended by your healthcare practitioner.
Children (under 12 years): Take under the direction of your
healthcare practitioner.
NDC 62106-1156-8
UNDA
numbered compounds
UNDA 219
Homeopathic Preparation
Helps to promote relaxation and temporarily relieve mild nervousness.
Contains 31% Alcohol
0.7 fl oz (20 ml)
* Please review the disclaimer below.
