Metabolic Reset

Metabolic Reset
SPL v2
SPL
SPL Set ID 2a3dd066-ec16-493d-a3b2-2bb5eb2e321c
Route
ORAL
Published
Effective Date 2019-07-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetic Acid (10 [hp_X]) Semecarpus Anacardium Juice (14 [hp_X]) Barium Cation (12 [hp_X]) Oyster Shell Calcium Carbonate, Crude (5 [hp_X]) Capsicum (7 [hp_X]) Fucus Vesiculosus (16 [hp_X]) Graphite Sodium Cation Phytolacca Americana Root Tin Thyroid, Unspecified Zinc
Inactive Ingredients
Alcohol Glycerin Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-07-01

Description

​Active Ingredients ​(HPUS*): Equal amounts of:   Aceticum   Acidum   10X,  Anacardium Orientale 14X   Baryta Iodata  12X,  Calcarea Carbonica  14X, Capsicum Acidum 14X, Focus Versiculosus 5X, Graphites 14X,  Natrum Sulphuricum 14X, Phytolacca Decandra 7X, Stannum Metallicum 16X, Thyroidinum 12X Zincum Metallicum 14X *" ​HPUS" statement: The letters "HPUS" indicate ​ ​ ​that the components in this product are officially monographed          in       the       ​Homeopathic ​Pharmacopoeia of the Unites States. † ​Claims  based   on   traditional  homeopathic ​practice, not accepted medical evidence. Not ​FDA evaluated. ​


Medication Information

Warnings and Precautions

​Warnings:

•If pregnant or breastfeeding, ask a health

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.

Indications and Usage

​Uses†: ​Temporarily relieves food cravings.

Helps control appetite and balance metabolism

to reduce weight gain.

Dosage and Administration

​Directions: ​Shake 10 times before use. Adults

and children above 12 years of age: spray 3-4

times under the tongue 30 minutes before each

meal    or   as   directed   by   a   health   care

professional.    Children under 12 years  use half

the adult dose.

Description

​Active Ingredients ​(HPUS*): Equal amounts of:   Aceticum   Acidum   10X,  Anacardium Orientale 14X   Baryta Iodata  12X,  Calcarea Carbonica  14X, Capsicum Acidum 14X, Focus Versiculosus 5X, Graphites 14X,  Natrum Sulphuricum 14X, Phytolacca Decandra 7X, Stannum Metallicum 16X, Thyroidinum 12X Zincum Metallicum 14X *" ​HPUS" statement: The letters "HPUS" indicate ​ ​ ​that the components in this product are officially monographed          in       the       ​Homeopathic ​Pharmacopoeia of the Unites States. † ​Claims  based   on   traditional  homeopathic ​practice, not accepted medical evidence. Not ​FDA evaluated. ​

Section 50565-1

​•Keep out of reach of children.

Section 51727-6

​Inactive  Ingredients:  ​Ethanol Alcohol 15%

(Non-GMA, Kosher Certified, Corn Free, Gluten

Free, Allergen Free), Glycerin     15%,  Purified

Water.

Section 51945-4

​Metabolic Reset

​Reset for Life

​2 fl oz (59 mL) 15% Ethanol

Section 53413-1

Distributed by Functional Medicine, Inc. 5900 W

Odgen Ave. Cicero, IL 60804

Manufacturer FDA Est # 3003231743

Section 55105-1

Temporarily relieves food cravings.

Helps control appetite and balance metabolism

to reduce weight gain.

Section 55106-9

​Active Ingredients ​(HPUS*): Equal amounts

of:   Aceticum   Acidum   10X,  Anacardium

Orientale 14X   Baryta Iodata  12X,  Calcarea

Carbonica  14X, Capsicum Acidum 14X, Focus

Versiculosus 5X, Graphites 14X,  Natrum

Sulphuricum 14X, Phytolacca Decandra 7X,

Stannum Metallicum 16X, Thyroidinum 12X

Zincum Metallicum 14X

*" ​HPUS" statement: The letters "HPUS" indicate

​that the components in this product are officially

monographed          in       the       ​Homeopathic

​Pharmacopoeia of the Unites States.

​Claims  based   on   traditional  homeopathic

​practice, not accepted medical evidence. Not

​FDA evaluated.


Structured Label Content

Indications and Usage (34067-9)

​Uses†: ​Temporarily relieves food cravings.

Helps control appetite and balance metabolism

to reduce weight gain.

Dosage and Administration (34068-7)

​Directions: ​Shake 10 times before use. Adults

and children above 12 years of age: spray 3-4

times under the tongue 30 minutes before each

meal    or   as   directed   by   a   health   care

professional.    Children under 12 years  use half

the adult dose.

Warnings and Precautions (34071-1)

​Warnings:

•If pregnant or breastfeeding, ask a health

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.

Section 50565-1 (50565-1)

​•Keep out of reach of children.

Section 51727-6 (51727-6)

​Inactive  Ingredients:  ​Ethanol Alcohol 15%

(Non-GMA, Kosher Certified, Corn Free, Gluten

Free, Allergen Free), Glycerin     15%,  Purified

Water.

Section 51945-4 (51945-4)

​Metabolic Reset

​Reset for Life

​2 fl oz (59 mL) 15% Ethanol

Section 53413-1 (53413-1)

Distributed by Functional Medicine, Inc. 5900 W

Odgen Ave. Cicero, IL 60804

Manufacturer FDA Est # 3003231743

Section 55105-1 (55105-1)

Temporarily relieves food cravings.

Helps control appetite and balance metabolism

to reduce weight gain.

Section 55106-9 (55106-9)

​Active Ingredients ​(HPUS*): Equal amounts

of:   Aceticum   Acidum   10X,  Anacardium

Orientale 14X   Baryta Iodata  12X,  Calcarea

Carbonica  14X, Capsicum Acidum 14X, Focus

Versiculosus 5X, Graphites 14X,  Natrum

Sulphuricum 14X, Phytolacca Decandra 7X,

Stannum Metallicum 16X, Thyroidinum 12X

Zincum Metallicum 14X

*" ​HPUS" statement: The letters "HPUS" indicate

​that the components in this product are officially

monographed          in       the       ​Homeopathic

​Pharmacopoeia of the Unites States.

​Claims  based   on   traditional  homeopathic

​practice, not accepted medical evidence. Not

​FDA evaluated.


Advanced Ingredient Data


Raw Label Data

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