The following Structured Product Label (SPL) was submitted to the FDA by Seroyal Usa for the product Pyrogenium Plex (NDC 62106-1233). 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:
Arsenicum album (Arsenic trioxide) 5CH
Hepar sulphuris calcareum (Crude calcium sulfide) 5CH
Hydrastis canadensis (Golden seal) Underground Parts 5CH
Kali bichromicum (Potassium bichromate) 5CH
Kali iodatum (Potassium iodide) 5CH
Pyrogenium (Pyrogen) 6CH
Uses
Helps promote and maintain a healthy upper respiratory tract.
Temporarily alleviates symptoms associated with general nasal and sinus congestion.
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.
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.
Uses
Helps promote and maintain a healthy upper respiratory tract.
Temporarily alleviates symptoms associated with general nasal and sinus congestion.
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.
NDC 62106-1233-0
UNDA
plex
PYROGENIUM PLEX
Homeopathic Preparation
For the temporary relief of general nasal
and sinus congestion symptoms.
Contains 25% Alcohol
1 fl oz (30 mL)
* Please review the disclaimer below.
