Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID 4f114242-fbe0-4f23-bbe7-c74fa2d091aa
Route
ORAL
Published
Effective Date 2019-11-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bromide Ion (3 [hp_X]) Fucus Vesiculosus (4 [hp_X]) Sodium Sulfate Anhydrous (6 [hp_X]) Niacinamide (12 [hp_X]) Spongia Officinalis Skeleton, Roasted Thiamine Ion Pyridoxine Riboflavin Thyroid, Bovine Oyster Shell Calcium Carbonate, Crude Graphite
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2014-12-03

Description

AMMONIUM BROMATUM 3X,  FUCUS VESICULOSUS 3X,  NATRUM SULPHURICUM 3X,  NICOTINAMIDUM 3X,  SPONGIA TOSTA 3X,  THIAMINUM HYDROCHLORICUM 4X,  PYRIDOXINUM HYDROCHLORICUM 6X,  RIBOFLAVINUM 6X,  THYROIDINUM (BOVINE) 6X,  CALCAREA CARBONICA 12X,  GRAPHITES 12X


Medication Information

Description

AMMONIUM BROMATUM 3X,  FUCUS VESICULOSUS 3X,  NATRUM SULPHURICUM 3X,  NICOTINAMIDUM 3X,  SPONGIA TOSTA 3X,  THIAMINUM HYDROCHLORICUM 4X,  PYRIDOXINUM HYDROCHLORICUM 6X,  RIBOFLAVINUM 6X,  THYROIDINUM (BOVINE) 6X,  CALCAREA CARBONICA 12X,  GRAPHITES 12X

Warnings:

If pregnant or breast feeding, do not 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.

Questions:

Manufactured for and distributed by

Integrative Health Alliance

1089 Granada Blvd Ste 3

Ormond Beach, FL 32174

Directions:

Adults: Take 10 drops orally 3 times a day. Take 30 minutes before eating.

Shake well before using. Store at room temperature away from light.

Consult a physician for use in children under 12 years of age.

Active Ingredients:

AMMONIUM BROMATUM 3X,  FUCUS VESICULOSUS 3X,  NATRUM SULPHURICUM 3X,  NICOTINAMIDUM 3X,  SPONGIA TOSTA 3X,  THIAMINUM HYDROCHLORICUM 4X,  PYRIDOXINUM HYDROCHLORICUM 6X,  RIBOFLAVINUM 6X,  THYROIDINUM (BOVINE) 6X,  CALCAREA CARBONICA 12X,  GRAPHITES 12X

Indication for Use:

Safe weight management

Inactive Ingredients:

Demineralized Water, Ethanol 25%

Package Label Display:

ESSENTIAL

WEIGHT LOSS

HOMEOPATHIC

Promotes Increased

Metabolism*

Enhances Energy Levels*

Regulates Appetite*

25%Ethanol

30 ml (1 fl oz)

Made in USA

*These statements have not been evaluated by the Food and Drug Administration.

This product is not intended to treat, cure or prevent any disease.*

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.


Structured Label Content

Warnings: (WARNINGS:)

If pregnant or breast feeding, do not 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.

Questions: (QUESTIONS:)

Manufactured for and distributed by

Integrative Health Alliance

1089 Granada Blvd Ste 3

Ormond Beach, FL 32174

Directions: (DIRECTIONS:)

Adults: Take 10 drops orally 3 times a day. Take 30 minutes before eating.

Shake well before using. Store at room temperature away from light.

Consult a physician for use in children under 12 years of age.

Active Ingredients: (ACTIVE INGREDIENTS:)

AMMONIUM BROMATUM 3X,  FUCUS VESICULOSUS 3X,  NATRUM SULPHURICUM 3X,  NICOTINAMIDUM 3X,  SPONGIA TOSTA 3X,  THIAMINUM HYDROCHLORICUM 4X,  PYRIDOXINUM HYDROCHLORICUM 6X,  RIBOFLAVINUM 6X,  THYROIDINUM (BOVINE) 6X,  CALCAREA CARBONICA 12X,  GRAPHITES 12X

Indication for Use: (INDICATION FOR USE:)

Safe weight management

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, Ethanol 25%

Package Label Display: (PACKAGE LABEL DISPLAY:)

ESSENTIAL

WEIGHT LOSS

HOMEOPATHIC

Promotes Increased

Metabolism*

Enhances Energy Levels*

Regulates Appetite*

25%Ethanol

30 ml (1 fl oz)

Made in USA

*These statements have not been evaluated by the Food and Drug Administration.

This product is not intended to treat, cure or prevent any disease.*

Keep Out of Reach of Children: (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

All Sections (JSON)