MEDULLOSSEINUM PLEX- arnica montana, calcarea phosphorica, calendula officinalis, hypericum perforatum, medullosseinum, pulsatilla, ruta graveolens, symphytum officinale liquid

MEDULLOSSEINUM PLEX by

Drug Labeling and Warnings

MEDULLOSSEINUM PLEX by is a Homeopathic medication manufactured, distributed, or labeled by Seroyal USA, SAN'UP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Each drop contains equal parts of:
Arnica montana (Leopard's bane) Underground Parts 5CH
Calcarea phosphorica (Calcium hydrogen phosphate) 4CH
Calendula officinalis (Marigold) Flowering Top 5CH
Hypericum perforatum (St. John's wort) Whole Plant 5CH
Medullosseinum (Spinal cord from Oryctolagus cuniculus) 7CH
Pulsatilla (Wind flower) Whole Flowering Plant 5CH
Ruta graveolens (Rue) Aerial Parts 5CH
Symphytum officinale (Comfrey) Underground Parts 5CH

PURPOSE

Uses

Helps promote and maintain overall bone health.

Assists with the temporary relief of general mild back pain.

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.

STOP USE

Stop use and ask a doctor if symptoms persist or worsen.

PREGNANCY OR BREAST FEEDING

If pregnant or breastfeeding, ask a health professional before use.

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.

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.

INACTIVE INGREDIENT

Inactive ingredients
Ethanol (beet), purified water

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.

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

Helps promote and maintain overall bone health.
Assists with the temporary relief of general mild back pain.

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.

PRINCIPAL DISPLAY PANEL

NDC: 62106-9916-0

UNDA

Plex

MEDULLOSSEINUM PLEX

Homeopathic Preparation

For the temporary relief of general mild back pain.

Contains 25% Alcohol
1 fl oz (30 mL)

INGREDIENTS AND APPEARANCE

MEDULLOSSEINUM PLEX 
arnica montana, calcarea phosphorica, calendula officinalis, hypericum perforatum, medullosseinum, pulsatilla, ruta graveolens, symphytum officinale liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62106-9916
Route of Administration	SUBLINGUAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	5 [hp_C]  in 30 mL
ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327)	ARNICA MONTANA ROOT	5 [hp_C]  in 30 mL
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	4 [hp_C]  in 30 mL
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ)	COMFREY ROOT	5 [hp_C]  in 30 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	5 [hp_C]  in 30 mL
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S)	RUTA GRAVEOLENS FLOWERING TOP	5 [hp_C]  in 30 mL
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	5 [hp_C]  in 30 mL
ORYCTOLAGUS CUNICULUS SPINAL CORD (UNII: 49SKT79UB3) (ORYCTOLAGUS CUNICULUS SPINAL CORD - UNII:49SKT79UB3)	ORYCTOLAGUS CUNICULUS SPINAL CORD	7 [hp_C]  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62106-9916-0	1 in 1 CARTON	10/22/2015
1		30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/22/2015

Labeler - Seroyal USA (018361118)

Establishment
Name	Address	ID/FEI	Business Operations
SAN'UP		401010287	manufacture(62106-9916)