The following Structured Product Label (SPL) was submitted to the FDA by Seroyal Usa for the product Unda 39 (NDC 62106-1138). 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:
Absinthium (Common wormwood) Aerial Parts 4X
Allium cepa (Onion) Bulb 4X
Argentum metallicum (Silver) 12X
Asafoetida Gum Resin 4X
Cina Flower-heads 6X
Dryopteris filix-mas Rhizome 6X
Tanacetum vulgare Flower and Leaf 4X
Uses
For the temporary relief of minor symptoms associated with
irritability and anxiousness.
Warnings
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 symptoms persist or worsen, consult your healthcare practitioner.
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
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 minor symptoms
associated with irritability and anxiousness.
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.
Other information
Do not use if seal is missing or broken.
Store in a cool, dry place.
NDC 62106-1138-8
UNDA
numbered compounds
UNDA 39
Homeopathic Preparation
For the temporary relief of minor
symptoms associated with
irritability and anxiousness.
Contains 31% Alcohol
0.7 fl oz (20 ml)
* Please review the disclaimer below.
