The following Structured Product Label (SPL) was submitted to the FDA by Seroyal Usa for the product Unda 46 (NDC 62106-1145). 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 - stop use, inactive ingredient, 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
Aloe Inspissated Juice 10X
Argentum metallicum (Silver) 12X
Condurango Bark 4X
Jateorhiza palmata (Columbo) Root 4X
Mentha piperita Aerial Parts 4X
Uses
For the temporary relief of symptoms associated with
indigestion
lack of appetite
stomach aches
Warnings
Stop use and ask a doctor if symptoms persist or worsen.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 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
indigestion
lack of appetite
stomach aches
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 62106-1145-8
UNDA
numbered compounds
UNDA 46
Homeopathic Preparation
For the temporary relief of symptoms
associated with indigestion, lack of
appetite and stomach aches.
Contains 31% Alcohol
0.7 fl oz (20 ml)
* Please review the disclaimer below.
