Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID 1e4bccd6-11ed-42ca-8072-98996e1421c3
Route
ORAL
Published
Effective Date 2021-06-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Triticum Aestivum Whole (1 [hp_X]) Baptisia Tinctoria Root (3 [hp_X]) Capsicum (5 [hp_X]) Alpine Strawberry (6 [hp_X]) Hamamelis Virginiana Root Bark/stem Bark (8 [hp_X]) Quassia Amara Wood (12 [hp_X]) Senna Leaf (15 [hp_C]) Goldenseal (18 [hp_C]) Podophyllum Beef Liver Sus Scrofa Pancreas Bos Taurus Spleen Atropa Belladonna Cinchona Officinalis Bark Lycopodium Clavatum Spore Nitric Acid Strychnos Nux-vomica Seed Giardia Lamblia Entamoeba Histolytica
Inactive Ingredients
Melaleuca Cajuputi Leaf Oil Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2021-06-16

Description

Triticum Aestivum MT, Baptisia Tinctoria 3X, Capsicum Annuum 3X, Fragaria Vesca 3X, Hamamelis Virginiana 3X, Quassia (Amara) 3X, Senna (Cassia Angustifolia) 3X, Hydrastis Canadensis 5X, Podophyllum Peltatum 6X, Hepar Bovine 8X, Pancreas Suis 8X, Spleen (Bovine) 8X, Belladonna 12X, Cinchona Officinalis 12X, Lycopodium Clavatum 12X, Nitricum Acidum 12X, Nux Vomica 12X, Giardia Lamblia 15C, 30C, 100C, Entamoeba Histolytica 18C, 30C, 100C.


Medication Information

Description

Triticum Aestivum MT, Baptisia Tinctoria 3X, Capsicum Annuum 3X, Fragaria Vesca 3X, Hamamelis Virginiana 3X, Quassia (Amara) 3X, Senna (Cassia Angustifolia) 3X, Hydrastis Canadensis 5X, Podophyllum Peltatum 6X, Hepar Bovine 8X, Pancreas Suis 8X, Spleen (Bovine) 8X, Belladonna 12X, Cinchona Officinalis 12X, Lycopodium Clavatum 12X, Nitricum Acidum 12X, Nux Vomica 12X, Giardia Lamblia 15C, 30C, 100C, Entamoeba Histolytica 18C, 30C, 100C.

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.

Questions:

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

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 symptoms of diarrhea, mucousy stools, intestinal bloating.

Active Ingredients:

Triticum Aestivum MT, Baptisia Tinctoria 3X, Capsicum Annuum 3X, Fragaria Vesca 3X, Hamamelis Virginiana 3X, Quassia (Amara) 3X, Senna (Cassia Angustifolia) 3X, Hydrastis Canadensis 5X, Podophyllum Peltatum 6X, Hepar Bovine 8X, Pancreas Suis 8X, Spleen (Bovine) 8X, Belladonna 12X, Cinchona Officinalis 12X, Lycopodium Clavatum 12X, Nitricum Acidum 12X, Nux Vomica 12X, Giardia Lamblia 15C, 30C, 100C, Entamoeba Histolytica 18C, 30C, 100C.

Inactive Ingredients:

Cajuput (Leaf) Essential Oil, Demineralized Water, 25% Ethanol

Package Label Display:

BIOActive Nutritional

STOMACHFORCE A

HOMEOPATHIC

1 FL OZ (30 ml)

Keep Out of Reach of Children:

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


Structured Label Content

Warnings: (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.

Questions: (QUESTIONS:)

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

Directions: (DIRECTIONS:)

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

Indications: (INDICATIONS:)

For temporary relief of symptoms of diarrhea, mucousy stools, intestinal bloating.

Active Ingredients: (ACTIVE INGREDIENTS:)

Triticum Aestivum MT, Baptisia Tinctoria 3X, Capsicum Annuum 3X, Fragaria Vesca 3X, Hamamelis Virginiana 3X, Quassia (Amara) 3X, Senna (Cassia Angustifolia) 3X, Hydrastis Canadensis 5X, Podophyllum Peltatum 6X, Hepar Bovine 8X, Pancreas Suis 8X, Spleen (Bovine) 8X, Belladonna 12X, Cinchona Officinalis 12X, Lycopodium Clavatum 12X, Nitricum Acidum 12X, Nux Vomica 12X, Giardia Lamblia 15C, 30C, 100C, Entamoeba Histolytica 18C, 30C, 100C.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Cajuput (Leaf) Essential Oil, Demineralized Water, 25% Ethanol

Package Label Display: (PACKAGE LABEL DISPLAY:)

BIOActive Nutritional

STOMACHFORCE A

HOMEOPATHIC

1 FL OZ (30 ml)

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.


Advanced Ingredient Data


Raw Label Data

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