FDA Label for Unda 312
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- WARNINGS
- OTC - ASK DOCTOR
- OTC - STOP USE
- OTC - DO NOT USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Unda 312 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:
Angelica archangelica (European angelica) Root 6X
Drosera (Sundew) Whole Plant 6X
Grindelia (Gum-plant) Aerial Parts 6X
Lamium album (Dead nettle) Aerial Parts 6X
Pinus sylvestris (Scotch pine) Shoots 6X
Rubus fruticosus (Shrubby blackberry) Leaf 6X
Senega officinalis (Snakeroot) Root 6X
Active ingredients
Each drop contains equal parts of:
Berberis vulgaris (Barberry) Bark 4X
Calcarea fluorica (Calcium fluoride) 12X
Otc - Purpose
Uses
For the relief of symptoms associated with sore throat.
Uses
For the relief of symptoms associated with low energy and fatigue
Warnings
Warnings
Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache,
nausea and vomiting may be serious.
Consult physician promptly.
Do not use more than 2 days or administer to children under 3 years of age unless directed by physician.
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.
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.
Otc - Ask Doctor
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.
Otc - Stop Use
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.
Stop use and ask a doctor if symptoms persist or worsen.
Stop use and ask a doctor if symptoms persist or worsen.
Otc - Do Not Use
Do not use more than 2 days or administer to children under 3 years of age unless directed by physician.
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.
Otc - 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.
Inactive Ingredient
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.
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.
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.
Indications & Usage
Uses
For the relief of symptoms associated with sore throat.
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 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.
Package Label.Principal Display Panel
UNDA
NDC 62106-1169-8
numbered compounds
UNDA 312
Homeopathic Preparation
For the relief of symptoms associated with sore throat.
Contains 31% Alcohol
0.7 fl oz (20 mL)
UNDA
NDC 62106-1171-8
numbered compounds
UNDA 700
Homeopathic Preparation
Contains 31% Alcohol
0.7 fl oz (20 mL)
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