The following Structured Product Label (SPL) was submitted to the FDA by Seroyal Usa for the product Unda 228 (NDC 62106-1159). 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, otc - ask doctor, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients
Each drop contains:
Lactuca virosa (Poisonous lettuce) Whole Plant 4X
Melissa officinalis (Lemon balm) Leaf/Young Shoot 4X
Millefolium (Yarrow) Aerial Parts 4X
Passiflora incarnata (Passion flower) Aerial Parts 4X
Thymus vulgaris Aerial Parts 4X
Valeriana officinalis (Valerian) Root 4X
Verbena officinalis (Common vervain) Aerial Parts 4X.
Uses
For the temporary relief of symptoms associated with occasional stress.
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.
Stop use and ask a doctor if symptoms persist or worsen.
Inactive Ingredients:
Ethanol (beet),
purified water
Other information
Do not use if seal is missing or broken.
Store in a cool, dry place.
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
For the temporary relief of symptoms associated with occasional stress.
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 62106-1159-8
UNDA
numbered compounds
UNDA 228
Homeopathic Preparation
For the temporary relief
of symptomsassociated with
occasional stress.
Contains 31% Alcohol
0.7 fl oz (20 ml)
* Please review the disclaimer below.
