Label: DR. RECKEWEG R81 MALDOL COMBINATION PRODUCT- cyclamen europaeum 4x, ginkgo biloba 3x, aranea diadema 4x, cimicifuga racemosa 4x, cocculus indicus 4x, colocynthis 4x, gelsemium sempervirens 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 3, 2013

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

  • ACTIVE INGREDIENT

    Active ingredients

    Cyclamen europaeum 4X 2 g, Ginkgo biloba 3X 2 g, Aranea diadema 4X, Cimicifuga racemosa 4X, Cocculus indicus 4X, Colocynthis 4X, Gelsemium sempervirens 3X, Spigelia anthelmia 4X, 1 g each in 10 g.

  • PURPOSE


    Purpose

    Relieves headaches and pain due to rheumatism, arthritis


  • INDICATIONS & USAGE


    Uses
    For the temporary relief of headaches and pain due to:


    • Rheumatism
    • Arthritis

  • WARNINGS

    Warnings

    Do not use

    • if hypersensitive to Ginkgo biloba.

    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 5-10 drops 1-3 times daily, in acute cases 4-6

    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# 53346-1381-5

    Dr. Reckeweg R81 Maldol

    Homeopathic preparation for the temporary relief of headaches and pain due to:

    • Rheumatism
    • Arthritis

    Manufactured by:

    Dr. Reckeweg Co. GmbH

    D-64625 Bensheim

    Germany

    1.68 fl oz
    (50 ml)

  • INGREDIENTS AND APPEARANCE
    DR. RECKEWEG R81 MALDOL  COMBINATION PRODUCT
    cyclamen europaeum 4x, ginkgo biloba 3x, aranea diadema 4x, cimicifuga racemosa 4x, cocculus indicus 4x, colocynthis 4x, gelsemium sempervirens 3x, spigelia anthelmia 4x liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53346-1381
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CYCLAMEN PURPURASCENS TUBER (UNII: G728143D8Q) (CYCLAMEN PURPURASCENS TUBER - UNII:G728143D8Q) CYCLAMEN PURPURASCENS TUBER4 [hp_X]  in 50 mL
    GINKGO (UNII: 19FUJ2C58T) (GINKGO - UNII:19FUJ2C58T) GINKGO3 [hp_X]  in 50 mL
    ARANEUS DIADEMATUS (UNII: 6T6CO7R3Z5) (ARANEUS DIADEMATUS - UNII:6T6CO7R3Z5) ARANEUS DIADEMATUS4 [hp_X]  in 50 mL
    BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH4 [hp_X]  in 50 mL
    ANAMIRTA COCCULUS SEED (UNII: 810258W28U) (ANAMIRTA COCCULUS SEED - UNII:810258W28U) ANAMIRTA COCCULUS SEED4 [hp_X]  in 50 mL
    CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP4 [hp_X]  in 50 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS 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:53346-1381-550 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(53346-1381)