Search by Drug Name or NDC

NDC 62106-9916-00 MEDULLOSSEINUM PLEX 5; 4; 5; 5; 5; 7; 5; 5 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL Details

MEDULLOSSEINUM PLEX 5; 4; 5; 5; 5; 7; 5; 5 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL

MEDULLOSSEINUM PLEX is a SUBLINGUAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Seroyal USA. The primary component is ARNICA MONTANA ROOT; CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; HYPERICUM PERFORATUM; ORYCTOLAGUS CUNICULUS SPINAL CORD; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP.

Product Information

NDC	62106-9916
Product ID	62106-9916_b13efa1f-d372-32f7-e053-2995a90a678c
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	MEDULLOSSEINUM PLEX
Proprietary Name Suffix	n/a
Non-Proprietary Name	Arnica montana, Calcarea phosphorica, Calendula officinalis, Hypericum perforatum, Medullosseinum, Pulsatilla, Ruta graveolens, Symphytum officinale
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	SUBLINGUAL
Active Ingredient Strength	5; 4; 5; 5; 5; 7; 5; 5
Active Ingredient Units	[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL
Substance Name	ARNICA MONTANA ROOT; CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; HYPERICUM PERFORATUM; ORYCTOLAGUS CUNICULUS SPINAL CORD; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP
Labeler Name	Seroyal USA
Pharmaceutical Class	Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 62106-9916-00 (62106991600)

Pricing Information	N/A
NDC Package Code	62106-9916-0
Billing NDC	62106991600
Package	1 BOTTLE, GLASS in 1 CARTON (62106-9916-0) / 30 mL in 1 BOTTLE, GLASS
Marketing Start Date	2015-10-22
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 22b7eafe-ef76-0677-e054-00144ff88e88 Details

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Uses

Helps promote and maintain overall bone health.

Assists with the temporary relief of general mild back pain.

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Keep out of reach of children.

SPL UNCLASSIFIED SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

Inactive ingredients

Ethanol (beet), purified water

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		10/22/2015

Labeler - Seroyal USA (018361118)

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

Revised: 10/2020

Document Id: b13efa1f-d372-32f7-e053-2995a90a678c

Set id: 22b7eafe-ef76-0677-e054-00144ff88e88

Version: 4

Effective Time: 20201009

Search by Drug Name or NDC

NDC 62106-9916-00 MEDULLOSSEINUM PLEX 5; 4; 5; 5; 5; 7; 5; 5 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL Details

MEDULLOSSEINUM PLEX 5; 4; 5; 5; 5; 7; 5; 5 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL

Product Information

Package

Package Images

NDC 62106-9916-00 (62106991600)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 22b7eafe-ef76-0677-e054-00144ff88e88 Details

SPL UNCLASSIFIED SECTION

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SPL UNCLASSIFIED SECTION

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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