Label: DR. RECKEWEG R34 CALCOSSIN COMBINATION PRODUCT- calcarea carbonica 30x, calcarea fluorica 12x, calcarea hypophosphorosa 6x, calcarea phosphorica 12x, chamomilla 6x, hekla lava 12x, mercurius praecipitatus ruber 12x, mezereum 6x, silicea 30x 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

    Calcarea carbonica 30X, Calcarea fluorica 12X, Calcarea hypophosphorosa 6X, Calcarea phosphorica 12X, Chamomilla 6X, Hekla Lava 12X, Mercurius praecipitatus ruber 12X, Mezereum 6X, Silicea 30X,  

    1 g each in 10 g.

  • PURPOSE

    Purpose

    Relieves symptoms associated with osteoporosis in adults and bone growth in children

  • INDICATIONS & USAGE

    Uses

    For the temporary relief of minor symptoms associated with osteoporosis in adults and bone growth in children such as:

    • Minor pain in bones
    • Demineralization
  • WARNINGS

    Warnings

    Do not use

    • if allergic to plants of the daisy (Asteraceae/Compositae) family.


    Ask a doctor before use

    • in children at the age of 2-11 years.

    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 a little water or undiluted or as recommended. For children (2-11 years): consult a health care professional before use.

  • 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# 53346-1334-5

    Dr. Reckeweg R34 Calcossin

    Homeopathic preparation for the temporary relief of minor symptoms associated with osteoporosis and bone growth in children such as:

    • Minor pain in bones
    • Demineralization


    Manufactured by:

    Dr. Reckeweg Co. GmbH

    D-64625 Bensheim

    Germany

                                         
    1.68 fl oz
    (50 ml)

  • INGREDIENTS AND APPEARANCE
    DR. RECKEWEG R34 CALCOSSIN  COMBINATION PRODUCT
    calcarea carbonica 30x, calcarea fluorica 12x, calcarea hypophosphorosa 6x, calcarea phosphorica 12x, chamomilla 6x, hekla lava 12x, mercurius praecipitatus ruber 12x, mezereum 6x, silicea 30x liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53346-1334
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE30 [hp_X]  in 50 mL
    CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE12 [hp_X]  in 50 mL
    CALCIUM HYPOPHOSPHITE (UNII: CUI83R2732) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM PHOSPHATE6 [hp_X]  in 50 mL
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP) (CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS - UNII:L11K75P92J) CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE12 [hp_X]  in 50 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA6 [hp_X]  in 50 mL
    HEKLA LAVA (UNII: C21158IIRK) (HEKLA LAVA - UNII:C21158IIRK) HEKLA LAVA12 [hp_X]  in 50 mL
    MERCURIC OXIDE (UNII: IY191986AO) (MERCURIC OXIDE - UNII:IY191986AO) MERCURIC OXIDE12 [hp_X]  in 50 mL
    DAPHNE MEZEREUM BARK (UNII: X2N6E405GV) (DAPHNE MEZEREUM BARK - UNII:X2N6E405GV) DAPHNE MEZEREUM BARK6 [hp_X]  in 50 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE30 [hp_X]  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53346-1334-550 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(53346-1334)
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