Label: DR. RECKEWEG R10 KLIMAKTERAN COMBINATION PRODUCT- cimicifuga racemosa 6x, lachesis mutus 12x, sanguinaria canadensis 6x, sepia 6x, sulfuricum acidum 6x 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 3, 2013

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

  • ACTIVE INGREDIENT

    Active ingredients

    Cimicifuga racemosa 6X, Lachesis mutus 12X, Sanguinaria canadensis 6X, Sepia 6X, Sulphuricum acidum 6X, 1 g each in 10 g.

  • PURPOSE


    Purpose

    Relieves symptoms associated with menopause


  • INDICATIONS & USAGE


    Uses

    For the temporary relief of minor symptoms associated with menopause such as:


    • Hot flashes
    • Moodiness
    • Irritability
  • 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: 10-15 drops 1-3 times daily;

    acute cases: 10-15 drops 3-6 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# 53346-1310-5

    Dr. Reckeweg R10 Klimakteran

    Homeopathic preparation for the temporary relief of minor symptoms associated with menopause such as:

    • Hot flashes
    • Moodiness
    • Irritability


    Manufactured by:

    Dr. Reckeweg Co. GmbH

    D-64625 Bensheim

    Germany


    1.68 fl oz
    (50 ml)

  • INGREDIENTS AND APPEARANCE
    DR. RECKEWEG R10 KLIMAKTERAN  COMBINATION PRODUCT
    cimicifuga racemosa 6x, lachesis mutus 12x, sanguinaria canadensis 6x, sepia 6x, sulfuricum acidum 6x liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53346-1310
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH6 [hp_X]  in 50 mL
    LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM12 [hp_X]  in 50 mL
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT6 [hp_X]  in 50 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE 6 [hp_X]  in 50 mL
    SULFURIC ACID (UNII: O40UQP6WCF) (SULFURIC ACID - UNII:O40UQP6WCF) SULFURIC ACID6 [hp_X]  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53346-1310-550 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(53346-1310)