ESSENTIAL WEIGHT LOSS (ammonium bromatum, fucus vesiculosus, natrum sulphuricum, nicotinamidum, spongia tosta, thiaminum hydrochloricum, pyridoxinum hydrochloricum, riboflavinum, thyroidinum- bovine, calcarea carbonica, graphites liquid

ESSENTIAL WEIGHT LOSS by

Drug Labeling and Warnings

ESSENTIAL WEIGHT LOSS by is a Homeopathic medication manufactured, distributed, or labeled by Integrative Health Alliance, Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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.

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.

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.

INDICATION FOR USE:

Safe weight management

INACTIVE INGREDIENTS:

Demineralized Water, Ethanol 25%

QUESTIONS:

Manufactured for and distributed by

Integrative Health Alliance

1089 Granada Blvd Ste 3

Ormond Beach, FL 32174

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.*

INGREDIENTS AND APPEARANCE

ESSENTIAL WEIGHT LOSS 
ammonium bromatum, fucus vesiculosus, natrum sulphuricum, nicotinamidum, spongia tosta, thiaminum hydrochloricum, pyridoxinum hydrochloricum, riboflavinum, thyroidinum (bovine), calcarea carbonica, graphites liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69207-0001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AMMONIUM BROMIDE (UNII: R0JB3224WS) (BROMIDE ION - UNII:952902IX06)	AMMONIUM BROMIDE	3 [hp_X]  in 1 mL
FUCUS VESICULOSUS (UNII: 535G2ABX9M) (FUCUS VESICULOSUS - UNII:535G2ABX9M)	FUCUS VESICULOSUS	3 [hp_X]  in 1 mL
SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750)	SODIUM SULFATE	3 [hp_X]  in 1 mL
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	3 [hp_X]  in 1 mL
SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID)	SPONGIA OFFICINALIS SKELETON, ROASTED	3 [hp_X]  in 1 mL
THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE HYDROCHLORIDE	4 [hp_X]  in 1 mL
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	6 [hp_X]  in 1 mL
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	6 [hp_X]  in 1 mL
THYROID, BOVINE (UNII: MN18OTN73W) (THYROID, BOVINE - UNII:MN18OTN73W)	THYROID, BOVINE	6 [hp_X]  in 1 mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	12 [hp_X]  in 1 mL
GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O)	GRAPHITE	12 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69207-0001-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	12/03/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/03/2014

Labeler - Integrative Health Alliance (043368329)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(69207-0001) , api manufacture(69207-0001) , label(69207-0001) , pack(69207-0001)