Breakthrough M2 Men's Platinum

Breakthrough M2 Men's Platinum
SPL v2
SPL
SPL Set ID c7cbf2d4-81f0-4668-91f8-ed43a420be84
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 Carbonate Ion Lycopodium Clavatum Spore Chloride Ion Strychnos Nux-vomica Seed Pancrelipase Lipase Phytolacca Americana Root Sus Scrofa Testicle
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, Kali Carbonicum 6X, Lycopodium Clavatum 12X, Natrum Muriaticum 12X, Nux Vomica 30X, Pancreatinum 12X, Phytolacca Decandra 12X, Orchitinum 8X. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. *The letters ​"HPUS" ​ indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. 


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 CHILDREN . 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 swallowing. Consult a physician 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, Kali Carbonicum 6X, Lycopodium Clavatum 12X, Natrum Muriaticum 12X, Nux Vomica 30X, Pancreatinum 12X, Phytolacca Decandra 12X, Orchitinum 8X. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. *The letters ​"HPUS" ​ indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. 

Section 50565-1

​KEEP OUT OF REACH OF CHILDREN.

Section 51727-6

Inactive ingredients:

Ethyl Alcohol, Purified Water.

Section 51945-4

NDC 70965-001-02

Breakthrough M2

Homeopathic PLATINUM®

MEN

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, Kali Carbonicum 6X, Lycopodium Clavatum 12X, Natrum Muriaticum 12X, Nux Vomica 30X, Pancreatinum 12X, Phytolacca Decandra 12X, Orchitinum 8X.

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

*The letters ​"HPUS"​ indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. 

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 swallowing. Consult a physician 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 CHILDREN . 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 70965-001-02

Breakthrough M2

Homeopathic PLATINUM®

MEN

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, Kali Carbonicum 6X, Lycopodium Clavatum 12X, Natrum Muriaticum 12X, Nux Vomica 30X, Pancreatinum 12X, Phytolacca Decandra 12X, Orchitinum 8X.

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

*The letters ​"HPUS"​ indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. 

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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