FDA Label for Unda 12
View Indications, Usage & Precautions
Unda 12 Product Label
The following document was submitted to the FDA by the labeler of this product Seroyal Usa. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredients
Each drop contains:
Argentum metallicum (Silver) 12X
Aurum metallicum (Gold) 12X
Dulcamara (Bittersweet) Shoots 4X
Fagopyrum esculentum Aerial Parts 4X
Illicium verum (Star Anise) Fruit 4X
Lappa major (Great burdock) Root 4X
Salvia officinalis (Garden sage) Leaf 4X
Sarsaparilla Root 4X
Staphysagria (Stavesacre) Seed 12X
Viola tricolor (Pansy) Aerial Parts 4X
Active ingredients
Each drop contains:
Absinthium (Common wormwood) Aerial Parts 4X
Aconitum napellus (Aconite) Whole Plant 4X
Argentum metallicum (Silver) 12X
Boldo Leaf 4X
Chamomilla (German chamomile) Whole Flowering Plant 4X
Coffea tosta (Roasted coffee) Seed 4X
Jateorhiza palmata (Columbo) Root 4X
Manganum oxydatum nigrum (Manganese dioxide) 12X
Salvia officinalis (Garden sage) Leaf 4X
Active ingredients
Each drop contains:
Argentum metallicum (Silver) 12X
Crataegus (Hawthorn) Fruit 4X
Gelsemium sempervirens (Yellow jessamine) Underground Parts 4X
Hamamelis virginiana (Witch hazel) Bark 4X
Magnolia grandiflora Flower 4X
Spiraea ulmaria (Queen-of-the-meadow) Underground Parts 4X
Stannum metallicum (Tin) 12X
Valeriana officinalis (Valerian) Root 4X
Active ingredients
Each drop contains:
Antimonium crudum (Antimonous sulfide) 12X
Borago officinalis (Common borage) Leaf 4X
Cetraria islandica (Iceland moss) Whole Plant 4X
Drosera (Sundew) Whole Plant 4X
Mentha piperita (Peppermint) Aerial Parts 4X
Senega officinalis (Snakeroot) Root 4X
Otc - Purpose
Uses
For the temporary relief of symptoms associated with mild skin irritation.
Uses
For the temporary relief of symptoms associated with mild anxiousness and nervousness.
Uses
For the temporary relief of symptoms associated with
coldness or numbness of the extremities.
Uses
For the relief of symptoms associated with laryngitis and voice hoarseness.
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.
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.
Warnings
Ask a doctor before use if you have Persistent cough or chronic cough
such as occurs with smoking, asthma, chronic bronchitis, or emphysema and Cough that is accompanied by
excessive phlegm (mucus) or fever.
Stop use and ask a doctor if symptoms persist or worsen and 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.
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 - Stop Use
Stop use and ask a doctor if symptoms persist or worsen.
Stop use and ask a doctor if symptoms persist or worsen.
Stop use and ask a doctor if symptoms persist or worsen.
Stop use and ask a doctor if symptoms persist or worsen and 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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use.
If pregnant or breastfeeding, ask a health professional before use.
If pregnant or breastfeeding, ask a health professional before use.
If pregnant or breastfeeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Keep out of reach of children.
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.
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.
In case of overdose, get medical help or contact a Poison Control Center right away.
Inactive Ingredient
Inactive ingredients
Ethanol (beet), purified water
Inactive ingredients
Ethanol (beet), purified water
Inactive ingredients
Ethanol (beet), purified water
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.
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.
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.
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.
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.
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 mild skin irritation.
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 anxiousness and nervousness.
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
coldness or numbness of the extremities.
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 relief of symptoms associated with laryngitis and voice hoarseness.
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.
Otc - Ask Doctor
Ask a doctor before use if you have Persistent cough or chronic cough
such as occurs with smoking, asthma, chronic bronchitis, or emphysema and Cough that is accompanied by
excessive phlegm (mucus) or fever.
Package Label.Principal Display Panel
NDC 62106-1152-8
UNDA
numbered compounds
UNDA 12
Homeopathic Preparation
For the temporary relief of symptoms
associated with mild skin irritation.
Contains 31% Alcohol
0.7 fl oz (20 ml)
NDC 62106-1121-8
UNDA
numbered compounds
UNDA 22
Homeopathic Preparation
For the temporary relief of symptoms
associated with mild anxiousness
and nervousness.
Contains 31% Alcohol
0.7 fl oz (20 ml)
NDC 62106-1124-8
UNDA
numbered compounds
UNDA 25
Homeopathic Preparation
For the temporary relief of symptoms
associated with coldness or numbness
of the extremities.
Contains 31% Alcohol
0.7 fl oz (20 ml)
UNDA
NDC 62106-1126-8
numbered compounds
UNDA 27
Homeopathic Preparation
For the relief of symptoms associated with laryngitis and voice hoarseness.
Contains 31% Alcohol
0.7 fl oz (20 mL)
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