STOMAPLEX- carduus marianus, gentiana lutea, sambucus nigra, senna (cassia angustifolia), stomach (bovine), arsenicum album, atropinum sulphuricum, carbo vegetabilis, lycopodium clavatum, nux vomica, 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:

Carduus Marianus 3X, Gentiana Lutea 3X, Sambucus Nigra 3X, Senna (Cassia Angustifolia) 3X, Stomach (Bovine) 8X, Arsenicum Album 12X, Atropinum Sulphuricum 12X, Carbo Vegetabilis 12X, Lycopodium Clavatum 12X, Nux Vomica 12X, Phosphorus 12X.

INDICATIONS:

For temporary relief of aching in the stomach, nausea, flatulence, fullness in the abdomen, and indigestion.

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.

DIRECTIONS:

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

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol.

KEEP OUT OF REACH OF CHLDREN:

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

INDICATIONS:

For temporary relief of aching in the stomach, nausea, flatulence, fullness in the abdomen, and indigestion.

QUESTIONS:

Distributed by:
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
bioactivenutritional.com

PACKAGE LABEL DISPLAY:

BIOActive Nutritional

STOMAPLEX

HOMEOPATHIC

1 FL OZ (30 ml)

Stomaplex

STOMAPLEX
carduus marianus, gentiana lutea, sambucus nigra, senna (cassia angustifolia), stomach (bovine), arsenicum album, atropinum sulphuricum, carbo vegetabilis, lycopodium clavatum, nux vomica, phosphorus liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43857-0090
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SILYBUM MARIANUM SEED (UNII: U946SH95EE) (SILYBUM MARIANUM SEED - UNII:U946SH95EE)	SILYBUM MARIANUM SEED	3 [hp_X] in 1 mL
GENTIANA LUTEA ROOT (UNII: S72O3284MS) (GENTIANA LUTEA ROOT - UNII:S72O3284MS)	GENTIANA LUTEA ROOT	3 [hp_X] in 1 mL
SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U)	SAMBUCUS NIGRA FLOWERING TOP	3 [hp_X] in 1 mL
SENNA LEAF (UNII: AK7JF626KX) (SENNA LEAF - UNII:AK7JF626KX)	SENNA LEAF	3 [hp_X] in 1 mL
TRIPE (UNII: C46FS57S0X) (TRIPE - UNII:C46FS57S0X)	TRIPE	8 [hp_X] in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	12 [hp_X] in 1 mL
ATROPINE SULFATE (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I)	ATROPINE SULFATE	12 [hp_X] in 1 mL
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10)	ACTIVATED CHARCOAL	12 [hp_X] in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	12 [hp_X] in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	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:43857-0090-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	08/24/2016	02/19/2026

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		02/19/2013	02/19/2026

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43857-0090) , api manufacture(43857-0090) , label(43857-0090) , pack(43857-0090)