Label: DR. RECKEWEG R16 CIMISAN COMBINATION PRODUCT- cimicifuga racemosa 4x, gelsemium sempervirens 3x, iris versicolor 2x, sanguinaria canadensis 3x, spigelia anthelmia 4x 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 April 4, 2013

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  • ACTIVE INGREDIENT

    Active ingredients

    Cimicifuga racemosa 4X, Gelsemium sempervirens 3X, Iris versicolor 2X, Sanguinaria canadensis 3X, Spigelia anthelmia 4X, 1 g each in 10 g.  

  • PURPOSE


    Purpose

    Relieves migraine headache pain

  • INDICATIONS & USAGE


    Uses

    For the temporary relief of:


    • Migraine headache pain
  • WARNINGS


    Warnings


    Stop use and ask a doctor if symptoms persist, get worse, or if new symptoms occur.


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

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children ≥ 12 years: acute cases: 5-10 drops (up to 6 times per day);

    in chronic cases: 5-10 drops 3 times daily in a little water or undiluted or as recommended.

  • OTHER SAFETY INFORMATION


    Other information


    • Tamper resistant: do not use if safety ring at base of cap is broken.
    • Retain outer carton for full product information.
  • INACTIVE INGREDIENT


    Inactive ingredients

    Ethanol, purified water.

  • QUESTIONS


    Questions?
    Call 1-800-361-7872 or email questions@reckeweg.com
  • PRINCIPAL DISPLAY PANEL

    image of carton label

    NDC# 53346-1316-5

    Dr. Reckeweg R16 Cimisan

    Homeopathic preparation for the temporary relief of:

    • Migraine headache pain

    Manufactured by:

    Dr. Reckeweg Co. GmbH

    D-64625 Bensheim

    Germany


    1.68 fl oz
    (50 ml)

  • INGREDIENTS AND APPEARANCE
    DR. RECKEWEG R16 CIMISAN  COMBINATION PRODUCT
    cimicifuga racemosa 4x, gelsemium sempervirens 3x, iris versicolor 2x, sanguinaria canadensis 3x, spigelia anthelmia 4x liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53346-1316
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH4 [hp_X]  in 50 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT3 [hp_X]  in 50 mL
    IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR ROOT2 [hp_X]  in 50 mL
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT3 [hp_X]  in 50 mL
    SPIGELIA ANTHELMIA (UNII: WYT05213GE) (SPIGELIA ANTHELMIA - UNII:WYT05213GE) SPIGELIA ANTHELMIA4 [hp_X]  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53346-1316-550 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/01/1986
    Labeler - PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO (318602612)
    Establishment
    NameAddressID/FEIBusiness Operations
    PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO318602612manufacture(53346-1316)
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