Label: ALUMEN- aluminum potassium sulfate granule

  • Category: HUMAN OTC DRUG LABEL

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 December 17, 2019

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  • ACTIVE INGREDIENT

    Active Ingredient

    ALUMEN 30CH GR

  • PURPOSE

    Indications

    Helps to maintain a healthy digestive system

  • WARNINGS

    Warning:
    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.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions
    Adults: Take five granules three times daily or as recommended by your healthcare practitioner.
    Children: Take three granules and follow adult directions.

  • INDICATIONS & USAGE

    Indications

    Helps to maintain a healthy digestive system

    Directions
    Adults: Take five granules three times daily or as recommended by your healthcare practitioner.
    Children: Take three granules and follow adult directions.

  • INACTIVE INGREDIENT

    Inactive Ingredients
    Lactose,
    sucrose.

  • QUESTIONS

    QUESTIONS? 1-888-737-6925.

  • PRINCIPAL DISPLAY PANEL

    62106-4820

    UNDA
    Do not use if label perforation is broken
    Homeopathic Remedy
    NDC : 62106-4820-4
    ALUMEN
    Aluminum potassium sulfate
    140 granules
    Indications

    Helps to maintain a healthy digestive system

  • INGREDIENTS AND APPEARANCE
    ALUMEN 
    aluminum potassium sulfate granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-4820
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM ALUM (UNII: 1L24V9R23S) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) POTASSIUM ALUM3 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    LACTOSE (UNII: J2B2A4N98G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62106-4820-410 in 1 CARTON12/09/2015
    1140 in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/09/2015
    Labeler - Seroyal USA (018361118)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAN’UP401010287manufacture(62106-4820)