Label: ALLERSTAT I (chelidonium majus, echinacea (angustifolia), gentiana lutea, arsenicum album, carbo vegetabilis, lycopodium clavatum, nux vomica, phosphorus, pulsatilla- pratensis liquid

  • 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 September 1, 2021

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  • ACTIVE INGREDIENTS:

    (in each drop): 16.62% of Arsenicum Album 12X, Carbo Vegetabilis 12X, Lycopodium Clavatum 12X, Nux Vomica 12X, Phosphorus 12X, Pulsatilla (Pratensis) 12X; 0.10% of Chelidonium Majus 3X, Echinacea (Angustifolia) 3X, Gentiana Lutea 3X.

  • INDICATIONS:

    May temporarily relieve digestive symptoms, such as indigestion with flatulence and bloating and loss of weight, associated with problem foods.**

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

  • 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.

  • 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 and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    May temporarily relieve digestive symptoms, such as indigestion with flatulence and bloating and loss of weight, associated with problem foods.**

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

  • INACTIVE INGREDIENTS:

    Demineralized water, 20% Ethanol.

  • QUESTIONS:

    Dist. by Energique, Inc.

    201 Apple Blvd

    Woodbine, IA 51579 800.869.8078

  • PACKAGE LABEL DISPLAY:

    ENERGIQUE
    SINCE 1987
    HOMEOPATHIC REMEDY
    ALLERSTAT I
    1 fl. oz. (30 ml)

    Allerstat I

  • INGREDIENTS AND APPEARANCE
    ALLERSTAT  I
    chelidonium majus, echinacea (angustifolia), gentiana lutea, arsenicum album, carbo vegetabilis, lycopodium clavatum, nux vomica, phosphorus, pulsatilla (pratensis) liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44911-0268
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS3 [hp_X]  in 1 mL
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA3 [hp_X]  in 1 mL
    GENTIANA LUTEA ROOT (UNII: S72O3284MS) (GENTIANA LUTEA ROOT - UNII:S72O3284MS) GENTIANA LUTEA ROOT3 [hp_X]  in 1 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE12 [hp_X]  in 1 mL
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL12 [hp_X]  in 1 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE12 [hp_X]  in 1 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED12 [hp_X]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS12 [hp_X]  in 1 mL
    ANEMONE PRATENSIS (UNII: 8E272251DI) (ANEMONE PRATENSIS - UNII:8E272251DI) ANEMONE PRATENSIS12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44911-0268-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product10/20/201502/17/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/20/201502/17/2025
    Labeler - Energique, Inc. (789886132)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(44911-0268) , api manufacture(44911-0268) , label(44911-0268) , pack(44911-0268)
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