Label: CONSTIPATION- magnesium carbonate, magnesium chloride, horse chestnut, potassium alum, aluminum oxide, bryonia alba root, strychnos nux-vomica seed, silicon dioxide 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 January 2, 2020

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS (HPUS*): Magnesium Carbonicum 4X, Magnesium Muriaticum 4X, Aesculus Hippocastanum 12X, Alumen 12X, Alumina 12X, Bryonia Alba 12X, Nux Vomica 12X, Silicea 12X

  • PURPOSE

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

  • 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.

  • INDICATIONS & USAGE

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

  • 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.
    • Do not use if TAMPER EVIDENT seal is broken or missing.
  • DOSAGE & ADMINISTRATION

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

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: Ethyl Alcohol USP, Purified Water.

  • QUESTIONS

    Questions & Comments?

    Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

  • REFERENCES

    *The  letters “HPUS” indicate the components in the product are officially monographed in the Homeopathic Pharmacopeia of the United States.

    **These statements have not been reviewed by the FDA. They are based on traditional homeopathic practice.

  • PRINCIPAL DISPLAY PANEL

    NDC: 43406-0610-1

    CONSTIPATION

    HOMEOPATHIC

    1 fl oz (30 mL) / 20% Alcohol

    UPC: 877730001030

    image description

  • INGREDIENTS AND APPEARANCE
    CONSTIPATION 
    magnesium carbonate, magnesium chloride, horse chestnut, potassium alum, aluminum oxide, bryonia alba root, strychnos nux-vomica seed, silicon dioxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43406-0610
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D) MAGNESIUM CARBONATE4 [hp_X]  in 1 mL
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CHLORIDE4 [hp_X]  in 1 mL
    HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ) HORSE CHESTNUT12 [hp_X]  in 1 mL
    POTASSIUM ALUM (UNII: 1L24V9R23S) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) POTASSIUM ALUM12 [hp_X]  in 1 mL
    ALUMINUM OXIDE (UNII: LMI26O6933) (ALUMINUM OXIDE - UNII:LMI26O6933) ALUMINUM OXIDE12 [hp_X]  in 1 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT12 [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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43406-0610-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product09/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/01/2017
    Labeler - Natural Creations, Inc. (018022074)
    Establishment
    NameAddressID/FEIBusiness Operations
    OHM Pharma, Inc.030572478manufacture(43406-0610)
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