FDA Label for Allium Cepa Plex
View Indications, Usage & Precautions
Allium Cepa 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:
Allium cepa (Onion) Bulb 6X
Belladonna (Deadly nightshade) Whole Plant 6X (<1.43 x 10-8 % alkaloids, calculated)
Euphrasia officinalis (Eyebright) Whole Plant 6X
Hydrastis canadensis (Golden seal) Underground Parts 6X
Kali bichromicum (Potassium bichromate) 6X
Mercurius dulcis (Calomel) 6X
Sambucus nigra (European elder) Leaves and Inflorescences 6X
Otc - Purpose
Uses
For the temporary relief of nasal congestion and watery eyes due to colds and allergies.
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.
Otc - Stop Use
Stop use and ask a doctor if 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), 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.
Dosage frequency may be increased up to six times daily depending on the severity of symptoms.
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
For the temporary relief of nasal congestion and watery eyes due to colds and allergies.
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.
Dosage frequency may be increased up to six times daily depending on the severity of symptoms.
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 62106-1192-0
UNDA
plex
ALLIUM CEPA PLEX
Homeopathic Preparation
For the temporary relief of nasal congestion
and watery eyes due to colds and allergies.
Contains 30% Alcohol
1 fl oz (30 mL)
* Please review the disclaimer below.