Otc - Active Ingredient
Active ingredients
Each drop contains:
Argentum metallicum (Silver) 12X
Boldo Leaf 4X
Combretum raimbaultii Leaf 4X
Jateorhiza palmata (Columbo) Root 4X
Ricinus communis (Castor bean) Seed 4X
Unda 13 Liquid
FDA Label NDC 62106-1112
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Seroyal Usa for the product Unda 13 (NDC 62106-1112). 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.
Label Section Quick Index
Otc - Purpose
Uses
For the temporary relief of symptoms associated with digestive upset.
Warnings
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
In case of overdose, get medical help or contact a
Poison Control Center right away.
Otc - Stop Use
Stop use and ask a doctor if symptoms persist or worsen.
Inactive Ingredient
Inactive ingredients
Ethanol (beet), purified water
Other Safety Information
Other information
Do not use if seal is missing or broken.
Store in a cool, dry place.
Contents may not fill package in order to accommodate required labeling. Please rely on stated quantity.
Dosage & Administration
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.
Indications & Usage
Uses
For the temporary relief of symptoms associated with digestive upset.
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.
Package Label.Principal Display Panel
NDC 62106-1112-8
UNDA
numbered compounds
UNDA 13
Homeopathic Preparation
For the temporary relief of symptoms
associated with digestive upset.
Contains 40% Alcohol
0.7 fl oz (20 mL)
* Please review the disclaimer below.
