Label: CONVALLARIA MAJALIS - convallaria majalis liquid

  • NDC Code(s): 55714-6174-1
  • Packager: Newton Laboratories, 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 September 1, 2011

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

  • INDICATIONS & USAGE SECTION

    Aching of legs, Irregular pulse, Headache.

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  • DOSAGE & ADMINISTRATION SECTION

    Directions:  Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

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  • OTC - ACTIVE INGREDIENT SECTION

    Convallaria majalis 15x, 10x, 30c.

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  • OTC - PURPOSE SECTION

    Aching of legs, Irregular pulse, Headache.

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  • INACTIVE INGREDIENT SECTION

    Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%. 

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  • QUESTIONS SECTION

    www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
    Questions? 1.800.448.7256

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  • WARNINGS SECTION

    WARNINGS:  Keep out of reach of children.  Do not use if tamper-evident seal is broken or missing.  If symptoms worsen or persist for more than a few days, consult a doctor.  If pregnant or breast-feeding, ask a doctor before use.

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  • OTC - PREGNANCY OR BREAST FEEDING SECTION

    If pregnant or breast-feeding, ask a doctor before use.

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  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

    Keep out of reach of children.

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  • PACKAGE LABEL
  • INGREDIENTS AND APPEARANCE
    CONVALLARIA MAJALIS  
    convallaria majalis liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-6174
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Convallaria Majalis (UNII: QHH4HVF5QE) (Convallaria Majalis - UNII:QHH4HVF5QE) Convallaria Majalis 15 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Alcohol (UNII: 3K9958V90M)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55714-6174-1 30 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 09/01/2011
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    Name Address ID/FEI Business Operations
    Newton Laboratories, Inc. 788793610 MANUFACTURE(55714-6174)
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