Label: CONSTIPATION- magnesium carbonate, magnesium chloride, aesculus hippocastanum, flos, potassium alum, aluminum oxide, bryonia alba root, strychnos nux-vomica seed, silicon dioxide liquid

  • NDC Code(s): 43406-0070-1
  • Packager: Natural Creations, Inc.
  • 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 January 21, 2013

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS (HPUS*): Magnesium Carbonicum 3X, Magnesium Muriaticum 3X, Aesculus Hippocastanum 12X, Alumen 12X, Alumina 12X, Bryonia Alba 12X, Nux Vomica 12X, Silicea 12X

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  • PURPOSE

    USES: Temporarily relieves great straining, large, dry, hard, knotty stools, &/or other symptoms of constipation.

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  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center.

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  • INDICATIONS & USAGE

    USES: Temporarily relieves great straining, large, dry, hard, knotty stools, &/or other symptoms of constipation.

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  • WARNINGS

    WARNING:

    Consult a physician for use in children under 12 years of age. IF PREGNANT OR BREAST-FEEDING, ask a health professional before use. KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

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  • DOSAGE & ADMINISTRATION

    DIRECTIONS: Adults & children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.

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  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: Purified Water, USP Ethanol Alcohol 20%

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  • PRINCIPAL DISPLAY PANEL

    NDC: 43406-0070-1

    CONSTIPATION

    Constipation

    HOMEOPATHIC

    1 fl oz (30 mL) / 20% Alcohol

    UPC: 877730001030

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  • INGREDIENTS AND APPEARANCE
    CONSTIPATION 
    magnesium carbonate, magnesium chloride, aesculus hippocastanum, flos, potassium alum, aluminum oxide, bryonia alba root, strychnos nux-vomica seed, silicon dioxide liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:43406-0070
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D) MAGNESIUM CARBONATE 3 [hp_X]  in 1 mL
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CHLORIDE 3 [hp_X]  in 1 mL
    AESCULUS HIPPOCASTANUM FLOWER (UNII: KK0Z92II8M) (AESCULUS HIPPOCASTANUM FLOWER - UNII:KK0Z92II8M) AESCULUS HIPPOCASTANUM FLOWER 12 [hp_X]  in 1 mL
    POTASSIUM ALUM (UNII: 1L24V9R23S) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) POTASSIUM ALUM 12 [hp_X]  in 1 mL
    ALUMINUM OXIDE (UNII: LMI26O6933) (ALUMINUM OXIDE - UNII:LMI26O6933) ALUMINUM OXIDE 12 [hp_X]  in 1 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 12 [hp_X]  in 1 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 12 [hp_X]  in 1 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (COLLOIDAL SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 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:43406-0070-1 30 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 05/29/2007
    Labeler - Natural Creations, Inc. (018022074)
    Establishment
    Name Address ID/FEI Business Operations
    OHM Pharma, Inc. 030572478 manufacture(43406-0070)
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