FDA Label for Lobelia Plex
View Indications, Usage & Precautions
Lobelia Plex 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:
Antimonium sulphuratum aureum (Golden antimony sulfide) 8X
Arsenicum iodatum (Arsenic triiodide) 8X
Blatta orientalis (Indian cockroach) Live Insect 6X
Eriodictyon californicum (Yerba santa) Aerial Parts 3X
Ipecacuanha (Ipecac) Underground Parts 4X
Lobelia inflata (Indian tobacco) Whole Plant 8X
Natrum sulphuricum (Sodium sulfate) 10X
Sambucus nigra (European elder) Leaves and Inflorescences 1X
Senega officinalis (Seneca snakeroot) Root 1X
Otc - Purpose
Uses
Assists with the temporary relief of cough.
Warnings
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.
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.
Symptoms persist or worsen.
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.
Inactive Ingredient
Inactive ingredients
Ethanol (beet), glycerin, 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
To be taken ten minutes away from food.
Invert bottle and shake lightly allowing drops to fall directly under the tongue or into ¼ oz of water.
Hold contents for about 20 seconds and swallow.
To promote drop flow, invert bottle and shake before each use.
Adults and adolescents (12 years and older)
Take 10 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
Assists with the temporary relief of cough.
Directions
To be taken ten minutes away from food.
Invert bottle and shake lightly allowing drops to fall directly under the tongue or into ¼ oz of water.
Hold contents for about 20 seconds and swallow.
To promote drop flow, invert bottle and shake before each use.
Adults and adolescents (12 years and older)
Take 10 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 62106-1195-0
UNDA
plex
LOBELIA PLEX
Homeopathic Preparation
Assists with the temporary relief of cough.
Contains 76% Alcohol
1 fl oz (30 mL)
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