The following Structured Product Label (SPL) was submitted to the FDA by Seroyal Usa for the product Unda 19 (NDC 62106-1118). 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 - keep out of reach of children, otc - pregnancy or breast feeding, otc - ask doctor, otc - stop use, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients
Each drop contains:
Aluminium metallicum (Aluminum) 12X
Drosera (Sundew) Whole Plant 5X
Illicium verum (Star anise) Fruit 3X
Mentha piperita Aerial Parts 5X
Senega officinalis (Seneca snakeroot) Root 4X
Uses
For the temporary relief of symptoms associated with minor respiratory problems.
Warnings
Ask a doctor before use if you have
Persistent or chronic cough such as
occurs with smoking, asthma, chronic
bronchitis, or emphysema.
Cough that is accompanied by
excessive phlegm (mucus) or fever.
Stop use and ask a doctor if
Cough persists for more than 1 week,
tends to recur, or is accompanied by a
fever, rash, or persistent headache. A
persistent cough may be a sign of a
serious condition.
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.
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.
Ask a doctor before use if you have
Persistent or chronic cough such as
occurs with smoking, asthma, chronic
bronchitis, or emphysema.
Cough that is accompanied by
excessive phlegm (mucus) or fever
Stop use and ask a doctor if
Cough persists for more than 1 week,
tends to recur, or is accompanied by a
fever, rash, or persistent headache. A
persistent cough may be a sign of a
serious condition.
Symptoms persist or worsen.
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
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 symptoms associated with minor respiratory problems.
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 62106-1118-8
UNDA
numbered compounds
UNDA 19
Homeopathic Preparation
For the temporary relief of symptoms
associated with minor respiratory problems.
Contains 32% Alcohol
0.7 fl oz (20 mL)
* Please review the disclaimer below.
