drug facts:

drug facts:
SPL v3
SPL
SPL Set ID a6824636-7098-4ac6-9199-c7fc5c7451df
Route
oral
Published
Effective Date 2026-03-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
beta vulgaris (3 [hp_X]) milk thistle (12 [hp_X]) arctium lappa root aluminum arsenic cation (3+) chelidonium majus goldenseal lycopodium clavatum spore sodium sulfate anhydrous strychnos nux-vomica seed phosphorus
Inactive Ingredients
water alcohol

Identifiers & Packaging

Marketing Status
unapproved homeopathic active Since 2015-05-21

Purpose

Aluminium Metallicum – stomach inflammation,** Arsenicum Album - nausea,** Beta Vulgaris – mucus congestion,** Carduus Marianus – upset stomach,** Chelidonium Majus - gas,** Hydrastis Canadensis - fever,** Lappa Major - cough,** Lycopodium Clavatum - bloating,** Natrum Sulphuricum – abdominal pain,** Nux Vomica – stomach cramps,** Phosphorus – stomach inflammation** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

Aluminium Metallicum 12X, Arsenicum Album 12X, Beta Vulgaris 3X, Carduus Marianus 3X, Chelidonium Majus 12X, Hydrastis Canadensis 12X, Lappa Major 3X, Lycopodium Clavatum 12X, Natrum Sulphuricum 12X, Nux Vomica 12X, Phosphorus 12X.


Medication Information

Purpose

Aluminium Metallicum – stomach inflammation,** Arsenicum Album - nausea,** Beta Vulgaris – mucus congestion,** Carduus Marianus – upset stomach,** Chelidonium Majus - gas,** Hydrastis Canadensis - fever,** Lappa Major - cough,** Lycopodium Clavatum - bloating,** Natrum Sulphuricum – abdominal pain,** Nux Vomica – stomach cramps,** Phosphorus – stomach inflammation** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

Aluminium Metallicum 12X, Arsenicum Album 12X, Beta Vulgaris 3X, Carduus Marianus 3X, Chelidonium Majus 12X, Hydrastis Canadensis 12X, Lappa Major 3X, Lycopodium Clavatum 12X, Natrum Sulphuricum 12X, Nux Vomica 12X, Phosphorus 12X.

Uses:

For temporary relief of bloating and fullness of the abdomen; flatulence; painful menses, abdominal cramping, and colic.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Purpose:

Aluminium Metallicum – stomach inflammation,** Arsenicum Album - nausea,** Beta Vulgaris – mucus congestion,** Carduus Marianus – upset stomach,** Chelidonium Majus - gas,** Hydrastis Canadensis - fever,** Lappa Major - cough,** Lycopodium Clavatum - bloating,** Natrum Sulphuricum – abdominal pain,** Nux Vomica – stomach cramps,** Phosphorus – stomach inflammation**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

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.

Questions:

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

1-800-288-9525

Directions:

• 10 drops orally, 3 times a day or as directed by a health care professional.

• Consult a health care professional for use in children under 12 years of age.

Active Ingredients:

Aluminium Metallicum 12X, Arsenicum Album 12X, Beta Vulgaris 3X, Carduus Marianus 3X, Chelidonium Majus 12X, Hydrastis Canadensis 12X, Lappa Major 3X, Lycopodium Clavatum 12X, Natrum Sulphuricum 12X, Nux Vomica 12X, Phosphorus 12X.

Inactive Ingredients:

Demineralized Water, 25% Ethanol

Package Label Display:

BIOActive Nutritional 

COLIC

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

Uses: (USES:)

For temporary relief of bloating and fullness of the abdomen; flatulence; painful menses, abdominal cramping, and colic.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Purpose: (PURPOSE:)

Aluminium Metallicum – stomach inflammation,** Arsenicum Album - nausea,** Beta Vulgaris – mucus congestion,** Carduus Marianus – upset stomach,** Chelidonium Majus - gas,** Hydrastis Canadensis - fever,** Lappa Major - cough,** Lycopodium Clavatum - bloating,** Natrum Sulphuricum – abdominal pain,** Nux Vomica – stomach cramps,** Phosphorus – stomach inflammation**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

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 a cool, dry place.

Questions: (QUESTIONS:)

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

1-800-288-9525

Directions: (DIRECTIONS:)

• 10 drops orally, 3 times a day or as directed by a health care professional.

• Consult a health care professional for use in children under 12 years of age.

Active Ingredients: (ACTIVE INGREDIENTS:)

Aluminium Metallicum 12X, Arsenicum Album 12X, Beta Vulgaris 3X, Carduus Marianus 3X, Chelidonium Majus 12X, Hydrastis Canadensis 12X, Lappa Major 3X, Lycopodium Clavatum 12X, Natrum Sulphuricum 12X, Nux Vomica 12X, Phosphorus 12X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 25% Ethanol

Package Label Display: (PACKAGE LABEL DISPLAY:)

BIOActive Nutritional 

COLIC

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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