Label: DR. RECKEWEG R35 CHADONTIN COMBINATION PRODUCT- aconitum napellus 6x, bryonia 30x, calcarea carbonica 30x, chamomilla 4x, colocynthis 12x, ignatia amara 30x, staphysagria 8x 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

    Aconitum napellus 6X, Bryonia 30X, Calcarea carbonica 30X, Chamomilla 4X, Colocynthis 12X, Ignatia amara 30X, Staphysagria 8X, 1 g each in 10 g.

  • PURPOSE

    Purpose

    Relieves discomfort and pain associated with teething

  • INDICATIONS & USAGE

    Uses

    For the temporary relief of:

    • Discomfort and pain associated with teething
  • WARNINGS

    Warnings

    Do not use

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

    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

    5-10 drops in some water 3-6 times daily 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# 53346-1335-5

    Dr. Reckeweg R35 Chadontin

    Homeopathic preparation for the temporary relief of:

    • Discomfort and pain associated with teething

    Manufactured by:

    Dr. Reckeweg Co. GmbH

    D-64625 Bensheim

    Germany

    1.68 fl oz
    (50 ml)

  • INGREDIENTS AND APPEARANCE
    DR. RECKEWEG R35 CHADONTIN  COMBINATION PRODUCT
    aconitum napellus 6x, bryonia 30x, calcarea carbonica 30x, chamomilla 4x, colocynthis 12x, ignatia amara 30x, staphysagria 8x liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53346-1335
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS6 [hp_X]  in 50 mL
    BRYONIA DIOICA ROOT (UNII: 53UB5FH7CX) (BRYONIA CRETICA SUBSP. DIOICA ROOT - UNII:53UB5FH7CX) BRYONIA DIOICA ROOT30 [hp_X]  in 50 mL
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE30 [hp_X]  in 50 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA4 [hp_X]  in 50 mL
    CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP12 [hp_X]  in 50 mL
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED30 [hp_X]  in 50 mL
    DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED8 [hp_X]  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53346-1335-550 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(53346-1335)
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