Sepia Plex

Sepia Plex
SPL v4
SPL
SPL Set ID 4c4a0a95-3848-4e19-e054-00144ff8d46c
Route
ORAL
Published
Effective Date 2017-04-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Black Cohosh (3 [hp_X]) Lachesis Muta Venom (8 [hp_X]) Platinum (2 [hp_X]) Sanguinaria Canadensis Root (6 [hp_X]) Sepia Officinalis Juice Melissa Officinalis Sulfuric Acid Valerian Aconitum Napellus
Inactive Ingredients
Alcohol Water Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2017-04-03

Description

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


Medication Information

Warnings and Precautions

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.

Indications and Usage

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.

Dosage and 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: Take 10 drops three times daily

or as recommended by your healthcare

practitioner.

Description

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

Section 50565-1

Keep out of reach of children. In case of

overdose, get medical help or contact a

Poison Control Center right away.

Section 51727-6

Inactive ingredients

Ethanol (beet), glycerin, purified water

Section 51945-4

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)

Section 53414-9

If pregnant or breastfeeding, ask a

health professional before use.

Section 55105-1

Uses

For the temporary relief of symptoms associated with menopause.

Section 55106-9

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

Section 60561-8

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.


Structured Label Content

Indications and Usage (34067-9)

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.

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of

overdose, get medical help or contact a

Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive ingredients

Ethanol (beet), glycerin, purified water

Section 51945-4 (51945-4)

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)

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a

health professional before use.

Section 55105-1 (55105-1)

Uses

For the temporary relief of symptoms associated with menopause.

Section 55106-9 (55106-9)

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

Section 60561-8 (60561-8)

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.


Advanced Ingredient Data


Raw Label Data

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