PACREAPLEX- chelidonium majus, glycyrrhiza glabra, nux moschata, rheum (officinale), syzygium jambolanum, taraxacum officinale,

United States - English - NLM (National Library of Medicine)

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Active ingredient:
CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN), GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) (GLYCYRRHIZA GLABRA - UNII:2788Z9758H), NUTMEG (UNII: AEE24M3MQ9) (NUTMEG - UNII:AEE24M3MQ9), RHEUM OFFICINALE ROOT (UNII: A47JP5ZG9M) (RHEUM OFFICINALE ROOT - UNII:A47JP5ZG9M), SYZYGIUM CUMINI SEED (UNII: 820LSF646I) (SYZYGIUM CUMINI SEED - UNII:820LSF646I), TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375), GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ), GO
Available from:
BioActive Nutritional, Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
For temporary relief of nervous anxiety, afternoon headache, feeling faint relieved by eating, craving of sweets, nervousness if meals missed. For temporary relief of nervous anxiety, afternoon headache, feeling faint relieved by eating, craving of sweets, nervousness if meals missed.
Authorization status:
unapproved homeopathic
Authorization number:
43857-0427-1

PACREAPLEX- chelidonium majus, glycyrrhiza glabra, nux moschata, rheum (officinale),

syzygium jambolanum, taraxacum officinale, zingiber officinale, hydrastis canadensis, glandula

suprarenalis suis, hepar suis, hypophysis suis, pancreas suis, thyroidinum (suis), phaseolus,

phosphoricum acidum, phosphorus liquid

BioActive Nutritional, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for

safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

----------

Drug Facts:

ACTIVE INGREDIENTS:

Chelidonium Majus 3X, Glycyrrhiza Glabra 3X, Nux Moschata 3X, Rheum (Officinale) 3X, Syzygium

Jambolanum 3X, Taraxacum Officinale 3X, Zingiber Officinale 3X, Hydrastis Canadensis 5X, Glandula

Suprarenalis Suis 6X, Hepar Suis 6X, Hypophysis Suis 6X, Pancreas Suis 6X, Thyroidinum (Suis) 8X,

Phaseolus 12X, Phosphoricum Acidum 12X, Phosphorus 12X.

INDICATIONS:

For temporary relief of nervous anxiety, afternoon headache, feeling faint relieved by eating, craving of

sweets, nervousness if meals missed.

WARNINGS:

If pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control

Center right away.

Do not use if tamper evident seal is broken or missing.

Store in cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control

Center right away.

DIRECTIONS:

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

INDICATIONS:

For temporary relief of nervous anxiety, afternoon headache, feeling faint relieved by eating, craving of

sweets, nervousness if meals missed.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

QUESTIONS:

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

PACKAGE LABEL DISPLAY:

BIOActive Nutritional

PANCREAPLEX

HOMEOPATHIC

1 FL OZ (30 ml)

PACREAPLEX

chelidonium majus, glycyrrhiza glabra, nux moschata, rheum (officinale), syzygium jambolanum, taraxacum

officinale, zingiber officinale, hydrastis canadensis, glandula suprarenalis suis, hepar suis, hypophysis suis, pancreas

suis, thyroidinum (suis), phaseolus, phosphoricum acidum, phosphorus liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:438 57-0 427

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CHELIDO NIUM MAJUS (UNII: 7E8 8 9 U5RNN) (CHELIDONIUM MAJUS -

UNII:7E8 8 9 U5RNN)

CHELIDONIUM MAJUS

3 [hp_X]

in 1 mL

GLYCYRRHIZA GLABRA (UNII: 278 8 Z9 758 H) (GLYCYRRHIZA GLABRA -

UNII:278 8 Z9 758 H)

GLYCYRRHIZA GLABRA

3 [hp_X]

in 1 mL

NUTMEG (UNII: AEE24M3MQ9 ) (NUTMEG - UNII:AEE24M3MQ9 )

NUTMEG

3 [hp_X]

in 1 mL

RHEUM O FFICINALE RO O T (UNII: A47JP5ZG9 M) (RHEUM OFFICINALE ROOT -

UNII:A47JP5ZG9 M)

RHEUM OFFICINALE

ROOT

3 [hp_X]

in 1 mL

SYZYGIUM CUMINI SEED (UNII: 8 20 LSF6 46 I) (SYZYGIUM CUMINI SEED -

UNII:8 20 LSF6 46 I)

SYZYGIUM CUMINI SEED

3 [hp_X]

in 1 mL

TARAXACUM O FFICINALE (UNII: 39 9 8 1FM375) (TARAXACUM OFFICINALE -

UNII:39 9 8 1FM375)

TARAXACUM

OFFICINALE

3 [hp_X]

in 1 mL

GINGER (UNII: C5529 G5JPQ) (GINGER - UNII:C5529 G5JPQ)

GINGER

3 [hp_X]

in 1 mL

GO LDENSEAL (UNII: ZW3Z11D0 JV) (GOLDENSEAL - UNII:ZW3Z11D0 JV)

GOLDENSEAL

5 [hp_X]

in 1 mL

SUS SCRO FA ADRENAL GLAND (UNII: 39 8 IYQ16 YV) (SUS SCROFA ADRENAL GLAND

- UNII:39 8 IYQ16 YV)

SUS SCROFA ADRENAL

GLAND

6 [hp_X]

in 1 mL

PO RK LIVER (UNII: 6 EC70 6 HI7F) (PORK LIVER - UNII:6 EC70 6 HI7F)

PORK LIVER

6 [hp_X]

in 1 mL

SUS SCRO FA PITUITARY GLAND (UNII: E8 S8 7O6 6 0 T) (SUS SCROFA PITUITARY

GLAND - UNII:E8 S8 7O6 6 0 T)

SUS SCROFA PITUITARY

GLAND

6 [hp_X]

in 1 mL

SUS SCRO FA PANCREAS (UNII: 9 Y3J336 2RY) (SUS SCROFA PANCREAS -

UNII:9 Y3J336 2RY)

SUS SCROFA PANCREAS

6 [hp_X]

in 1 mL

SUS SCRO FA THYRO ID (UNII: 6 RV0 24OAUQ) (SUS SCROFA THYROID -

UNII:6 RV0 24OAUQ)

SUS SCROFA THYROID

8 [hp_X]

in 1 mL

KIDNEY BEAN (UNII: M9 8 C8 416 QO) (KIDNEY BEAN - UNII:M9 8 C8 416 QO)

KIDNEY BEAN

12 [hp_X]

in 1 mL

PHO SPHO RIC ACID (UNII: E4GA8 8 8 4NN) (PHOSPHORIC ACID - UNII:E4GA8 8 8 4NN)

PHOSPHORIC ACID

12 [hp_X]

in 1 mL

PHO SPHO RUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)

PHOSPHORUS

12 [hp_X]

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:438 57-

0 427-1

30 mL in 1 BOTTLE, DROPPER; Type 0 : No t a Co mbinatio n

Pro duc t

0 1/24/20 17

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved ho meo pathic

0 1/24/20 17

Labeler -

BioActive Nutritional, Inc. (624980496)

Registrant -

Apotheca Company (844330915)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

BioActive Nutritional, Inc.

Apo the c a

Co mpany

8 44330 9 15

manufacture(438 57-0 427) , api manufacture(438 57-0 427) , label(438 57-0 427) , pack(438 57-

0 427)

Revised: 1/2017

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