Breakthrough M2 Women's Platinum

Breakthrough M2 Women's Platinum
SPL v2
SPL
SPL Set ID bb65a25a-6c5b-4773-8eed-b08cd76348d4
Route
ORAL
Published
Effective Date 2018-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oyster Shell Calcium Carbonate, Crude (12 [hp_X]) Capsicum (6 [hp_X]) Iron (8 [hp_X]) Sus Scrofa Adrenal Gland (10 [hp_X]) Graphite (18 [hp_X]) Pork Liver (30 [hp_X]) Bos Taurus Hypothalamus Iodine Carbonate Ion Sus Scrofa Ovary Pancrelipase Lipase Phytolacca Americana Root Pulsatilla Vulgaris Sepia Officinalis Juice
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2016-10-10

Description

Active Ingredients (HPUS*) equal amounts of: Calcarea Carbonica 12X, Capsicum Annuum 6X, Ferrum Metallicum 12X, Glandula Suprarenalis 8X, Graphites 12X, Hepar Suis 10X, Hypothalamus 18X, Iodium 6X, Kali Carbonicum 6X, Oophorinum 8X, Pancreatinum 12X, Phytolacca Decandra 12X, Pulsatilla 30X, Sepia 30X. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. *The letters " ​HPUS" ​indicate that the componenets in this product are officially monographed in the Homeopathic Pharmacopoeia of the  Unitied Sates.


Medication Information

Warnings and Precautions

Warnings

  • This product is not intended for use by children under 18 years of age.
  • IF PREGNANT OR NURSING or taking any medication, ask a healthcare professional before use.
  • KEEP OUT OF REACH OF CHILDERN. In case of accidental overdose, get medical help or contact a Poison Control Center immediately (800-222-1222).
Indications and Usage

Uses:

Temporarily gives support during weight management program.†

Dosage and Administration

​Directions: ​Use only as directed. Shake well before use. Take 12 drops, 3 times a day, 30 minutes before meals. Place drops under the tongue and hold for 10-15 seconds before starting any diet/exercise program.

Description

Active Ingredients (HPUS*) equal amounts of: Calcarea Carbonica 12X, Capsicum Annuum 6X, Ferrum Metallicum 12X, Glandula Suprarenalis 8X, Graphites 12X, Hepar Suis 10X, Hypothalamus 18X, Iodium 6X, Kali Carbonicum 6X, Oophorinum 8X, Pancreatinum 12X, Phytolacca Decandra 12X, Pulsatilla 30X, Sepia 30X. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. *The letters " ​HPUS" ​indicate that the componenets in this product are officially monographed in the Homeopathic Pharmacopoeia of the  Unitied Sates.

Section 50565-1

​KEEP OUT OF REACH OF CHILDREN.

Section 51727-6

Inactive ingredients:

Ethyl Alcohol, Purified Water

Section 51945-4

NDC 70965-002-02

Breakthrough

M2

Homeopathic 

PLATINUM®

​WOMEN

2 fl oz (60 mL)

Ethyl Alcohol 20%

Section 53413-1

Distributed By

Breakthrough M2 Inc.

2308 St. Rte 208, Montgomery, NY 12549

 (845) 713-4320

Visit www.breakthroughM2.com

Made in USA in FDA inspected facility.

Section 55105-1

Purpose: Supports healthy sleep, stable mood, lower stress levels, body processes and organ support while following a healthy weight management diet and exercise regimen.†

Section 55106-9

Active Ingredients (HPUS*)

equal amounts of: Calcarea Carbonica 12X, Capsicum Annuum 6X, Ferrum Metallicum 12X, Glandula Suprarenalis 8X, Graphites 12X, Hepar Suis 10X, Hypothalamus 18X, Iodium 6X, Kali Carbonicum 6X, Oophorinum 8X, Pancreatinum 12X, Phytolacca Decandra 12X, Pulsatilla 30X, Sepia 30X.

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

*The letters "​HPUS" ​indicate that the componenets in this product are officially monographed in the Homeopathic Pharmacopoeia of the 

Unitied Sates.

Section 60561-8

Other information:  • Store at room temperature away from heat and sunlight. • Do not use if tamper evident neck seal is missing or broken.


Structured Label Content

Indications and Usage (34067-9)

Uses:

Temporarily gives support during weight management program.†

Dosage and Administration (34068-7)

​Directions: ​Use only as directed. Shake well before use. Take 12 drops, 3 times a day, 30 minutes before meals. Place drops under the tongue and hold for 10-15 seconds before starting any diet/exercise program.

Warnings and Precautions (34071-1)

Warnings

  • This product is not intended for use by children under 18 years of age.
  • IF PREGNANT OR NURSING or taking any medication, ask a healthcare professional before use.
  • KEEP OUT OF REACH OF CHILDERN. In case of accidental overdose, get medical help or contact a Poison Control Center immediately (800-222-1222).
Section 50565-1 (50565-1)

​KEEP OUT OF REACH OF CHILDREN.

Section 51727-6 (51727-6)

Inactive ingredients:

Ethyl Alcohol, Purified Water

Section 51945-4 (51945-4)

NDC 70965-002-02

Breakthrough

M2

Homeopathic 

PLATINUM®

​WOMEN

2 fl oz (60 mL)

Ethyl Alcohol 20%

Section 53413-1 (53413-1)

Distributed By

Breakthrough M2 Inc.

2308 St. Rte 208, Montgomery, NY 12549

 (845) 713-4320

Visit www.breakthroughM2.com

Made in USA in FDA inspected facility.

Section 55105-1 (55105-1)

Purpose: Supports healthy sleep, stable mood, lower stress levels, body processes and organ support while following a healthy weight management diet and exercise regimen.†

Section 55106-9 (55106-9)

Active Ingredients (HPUS*)

equal amounts of: Calcarea Carbonica 12X, Capsicum Annuum 6X, Ferrum Metallicum 12X, Glandula Suprarenalis 8X, Graphites 12X, Hepar Suis 10X, Hypothalamus 18X, Iodium 6X, Kali Carbonicum 6X, Oophorinum 8X, Pancreatinum 12X, Phytolacca Decandra 12X, Pulsatilla 30X, Sepia 30X.

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

*The letters "​HPUS" ​indicate that the componenets in this product are officially monographed in the Homeopathic Pharmacopoeia of the 

Unitied Sates.

Section 60561-8 (60561-8)

Other information:  • Store at room temperature away from heat and sunlight. • Do not use if tamper evident neck seal is missing or broken.


Advanced Ingredient Data


Raw Label Data

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