The following Structured Product Label (SPL) was submitted to the FDA by Seroyal Usa for the product Sepia Plex (NDC 62106-0117). 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 - keep out of reach of children, otc - pregnancy or breast feeding, other safety information, inactive ingredient, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients
Each drop contains:
Aconitum napellus (Aconite) Whole Plant 6X
Cimicifuga racemosa (Black cohosh) Root and Rhizome 3X
Lachesis mutus (Bushmaster) Venom 8X
Melissa officinalis (Lemon balm) Leaf and Shoot 2X
Platinum metallicum (Platinum) 8X
Sanguinaria canadensis (Blood root) Underground Parts 3X
Sepia Dried Inky Secretion 3X
Sulphuricum acidum (Sulfuric acid) 6X
Valeriana officinalis (Valerian) Root 6X
Uses
For the temporary relief of symptoms associated with menopause.
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.
Keep out of reach of children. In case of
overdose, get medical help or contact a
Poison Control Center right away.
If pregnant or breastfeeding, ask a
health professional before use.
Other information
Do not use if seal is missing or broken.
Store in a cool, dry place.
Inactive ingredients
Ethanol (beet), glycerin, purified water
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: Take 10 drops three times daily
or as recommended by your healthcare
practitioner.
Uses
For the temporary relief of symptoms associated with menopause.
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: Take 10 drops three times daily
or as recommended by your healthcare
practitioner.
NDC 62106-0117-0
UNDA
plex
SEPIA PLEX
Homeopathic Preparation
For the temporary relief of symptoms associated with menopause.
Contains 31% Alcohol
1 fl oz (30 mL)
* Please review the disclaimer below.
