The following Structured Product Label (SPL) was submitted to the FDA by Seroyal Usa for the product Allium Cepa Plex (NDC 62106-1192). 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 - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, overdosage, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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
Uses
For the temporary relief of nasal congestion and watery eyes due to colds and allergies.
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.
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.
Inactive ingredients
Ethanol (beet), purified water
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.
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.
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.
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.
