PANCREAPLEX- chelidonium majus, glycyrrhiza glabra, nux moschata, rheum (palmatum), 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.

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DRUG FACTS:

ACTIVE INGREDIENTS:

Chelidonium Majus 3X, Glycyrrhiza Glabra 3X, Nux Moschata 3X, Rheum 3X, Syzygium Jambolanum 3X, Taraxacum Officinale 3X, Zingiber Officinale 3X, Hydrastis Canadensis 5X, Glandula Suprarenalis Suis 6X, Hepar Suis 6X, Hypophysis Suis 6X, Pancreas 6X, Thyroidinum 8X, Phaseolus 12X, Phosphoricum Acidum 12X, Phosphorus 12X.

PURPOSE:

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 a cool, dry place.

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:

BIOActiveNutritional

PANCREAPLEX

HOMEOPATHIC

1 FL OZ (30 ml)

PANCREAPLEX

PANCREAPLEX
chelidonium majus, glycyrrhiza glabra, nux moschata, rheum (palmatum), 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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43857-0590
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHELIDONIUM MAJUS WHOLE (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN)	CHELIDONIUM MAJUS WHOLE	3 [hp_X] in 1 mL
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) (GLYCYRRHIZA GLABRA - UNII:2788Z9758H)	GLYCYRRHIZA GLABRA	3 [hp_X] in 1 mL
NUTMEG (UNII: AEE24M3MQ9) (NUTMEG - UNII:AEE24M3MQ9)	NUTMEG	3 [hp_X] in 1 mL
RHEUM PALMATUM ROOT (UNII: G025DAL7CE) (RHEUM PALMATUM ROOT - UNII:G025DAL7CE)	RHEUM PALMATUM ROOT	3 [hp_X] in 1 mL
SYZYGIUM CUMINI SEED (UNII: 820LSF646I) (SYZYGIUM CUMINI SEED - UNII:820LSF646I)	SYZYGIUM CUMINI SEED	3 [hp_X] in 1 mL
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375)	TARAXACUM OFFICINALE	3 [hp_X] in 1 mL
GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ)	GINGER	3 [hp_X] in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	5 [hp_X] in 1 mL
SUS SCROFA ADRENAL GLAND (UNII: 398IYQ16YV) (SUS SCROFA ADRENAL GLAND - UNII:398IYQ16YV)	SUS SCROFA ADRENAL GLAND	6 [hp_X] in 1 mL
PORK LIVER (UNII: 6EC706HI7F) (PORK LIVER - UNII:6EC706HI7F)	PORK LIVER	6 [hp_X] in 1 mL
SUS SCROFA PITUITARY GLAND (UNII: L0PFEMQ1DT) (SUS SCROFA PITUITARY GLAND - UNII:L0PFEMQ1DT)	SUS SCROFA PITUITARY GLAND	6 [hp_X] in 1 mL
SUS SCROFA PANCREAS (UNII: 9Y3J3362RY) (SUS SCROFA PANCREAS - UNII:9Y3J3362RY)	SUS SCROFA PANCREAS	6 [hp_X] in 1 mL
THYROID (UNII: 6RV024OAUQ) (SUS SCROFA THYROID - UNII:6RV024OAUQ)	THYROID	8 [hp_X] in 1 mL
KIDNEY BEAN (UNII: M98C8416QO) (KIDNEY BEAN - UNII:M98C8416QO)	KIDNEY BEAN	12 [hp_X] in 1 mL
PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN)	PHOSPHORIC ACID	12 [hp_X] in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	12 [hp_X] in 1 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43857-0590-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	06/05/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		06/05/2023

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43857-0590) , api manufacture(43857-0590) , label(43857-0590) , pack(43857-0590)