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

  • NDC Code(s): 69207-0001-1
  • Packager: Integrative Health Alliance
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated November 11, 2019

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  • 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.*

    Essential Weight Loss

  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:69207-0001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMMONIUM BROMIDE (UNII: R0JB3224WS) (BROMIDE ION - UNII:952902IX06) AMMONIUM BROMIDE3 [hp_X]  in 1 mL
    FUCUS VESICULOSUS (UNII: 535G2ABX9M) (FUCUS VESICULOSUS - UNII:535G2ABX9M) FUCUS VESICULOSUS3 [hp_X]  in 1 mL
    SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE3 [hp_X]  in 1 mL
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE3 [hp_X]  in 1 mL
    SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED3 [hp_X]  in 1 mL
    THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE HYDROCHLORIDE4 [hp_X]  in 1 mL
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE6 [hp_X]  in 1 mL
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN6 [hp_X]  in 1 mL
    THYROID, BOVINE (UNII: MN18OTN73W) (THYROID, BOVINE - UNII:MN18OTN73W) THYROID, BOVINE6 [hp_X]  in 1 mL
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE12 [hp_X]  in 1 mL
    GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69207-0001-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product12/03/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/03/2014
    Labeler - Integrative Health Alliance (043368329)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(69207-0001) , api manufacture(69207-0001) , label(69207-0001) , pack(69207-0001)
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