The following Structured Product Label (SPL) was submitted to the FDA by Seroyal Usa for the product Unda 49 (NDC 62106-1148). 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 - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, overdosage, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients
Each drop contains:
Aurum metallicum (Gold) 12X
Condurango Bark 5X
Hypericum perforatum (St. John's Wort) Whole Plant 5X
Ocimum basilicum (Basil) Aerial Parts 5X
Plumbum metallicum (Lead) 12X
Active ingredients
Each drop contains:
Boldo Leaf 6X
Cynara scolymus (Artichoke) Aerial Parts 4X
Hamamelis virginiana (Witch hazel) Bark 4X
Lycopodium clavatum (Clubmoss) Spore 6X
Sepia Inky Juice 6X
Uses
For the temporary relief of symptoms associated with low energy and fatigue
Uses
For the temporary relief of symptoms associated with mild digestive distress.
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.
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.
Stop use and ask a doctor if symptoms persist or worsen.
Stop use and ask a doctor if symptoms persist or worsen.
If pregnant or breastfeeding, ask a health professional before use.
If pregnant or breastfeeding, ask a health professional before use.
Keep out of reach of children.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
In case of overdose, get medical help or contact a Poison Control Center right away.
Inactive ingredients
Ethanol (beet), purified water
Inactive ingredients
Ethanol (beet), purified water
Other information
Do not use if seal is missing or broken.
Store in a cool, dry place.
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.
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 low energy and fatigue
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 mild digestive distress.
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 62106-1148-8
UNDA
numbered compounds
UNDA 49
Homeopathic Preparation
For the temporary relief of symptoms
associated with low energy and fatigue.
Contains 31% Alcohol
0.7 fl oz (20 ml)
NDC 62106-1150-8
UNDA
numbered compounds
UNDA 74
Homeopathic Preparation
For the temporary relief of symptoms
associated with mild digestive distress.
Contains 31% Alcohol
0.7 fl oz (20 ml)
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