Label: AMBRA GRISEA- ambergris pellet

  • 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 March 28, 2018

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Ambra grisea

    6C,12C,15C,30C,200CK

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  • INDICATIONS & USAGE

    Ocassional sleeplessness with hypersensitivity*

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  • STOP USE

    Stop use and ask a doctor if symptoms persist for more than 3 days or worsen

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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding ask a health professional before use

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

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  • DOSAGE & ADMINISTRATION

    5 pellets 3 times a day until symptoms are relieved

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  • SPL UNCLASSIFIED SECTION

    Do not use if pellet dispenser seal is broken

    contains approx 80 pellets

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  • INACTIVE INGREDIENT

    lactose, sucrose

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  • QUESTIONS

    1-800-BOIRON-1

    Newtown Square, PA 19073-3267

    info@boironusa.com

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  • SPL UNCLASSIFIED SECTION

    These "Uses" have not been evaluated by the FDA

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  • INGREDIENTS AND APPEARANCE
    AMBRA GRISEA 
    ambergris pellet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0220-0221
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AMBERGRIS (UNII: XTC0D02P6C) (AMBERGRIS - UNII:XTC0D02P6C) AMBERGRIS 6 [hp_C]  in 6 [hp_C]
    Inactive Ingredients
    Ingredient Name Strength
    SUCROSE (UNII: C151H8M554)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    Product Characteristics
    Color white Score     
    Shape ROUND Size 4mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0220-0221-41 6 [hp_C] in 1 TUBE; Type 0: Not a Combination Product 03/03/1983
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 03/03/1983
    Labeler - Boiron (282560473)
    Registrant - Boiron, Inc. (014892269)
    Establishment
    Name Address ID/FEI Business Operations
    Boiron 282560473 manufacture(0220-0221)
    Establishment
    Name Address ID/FEI Business Operations
    Boiron 380022322 manufacture(0220-0221)
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